Support for healthy breastfeeding mothers with healthy term babies

  • Review
  • Intervention

Authors


Abstract

Background

There is extensive evidence of important health risks for infants and mothers related to not breastfeeding. In 2003, the World Health Organization recommended infants be exclusively breastfed until six months of age, with breastfeeding continuing as an important part of the infant’s diet till at least two years of age. However, breastfeeding rates in many countries currently do not reflect this recommendation.

Objectives

To assess the effectiveness of support for breastfeeding mothers.

Search methods

We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (3 October 2011).

Selection criteria

Randomised or quasi-randomised controlled trials comparing extra support for healthy breastfeeding mothers of healthy term babies with usual maternity care.

Data collection and analysis

Two review authors independently assessed trial quality and extracted data.

Main results

Of the 67 studies that we assessed as eligible for inclusion, 52 contributed outcome data to the review (56,451 mother-infant pairs) from 21 countries. All forms of extra support analysed together showed an increase in duration of 'any breastfeeding' (includes partial and exclusive breastfeeding) (risk ratio (RR) for stopping any breastfeeding before six months 0.91, 95% confidence interval (CI) 0.88 to 0.96). All forms of extra support together also had a positive effect on duration of exclusive breastfeeding (RR at six months 0.86, 95% CI 0.82 to 0.91; RR at four to six weeks 0.74, 95% CI 0.61 to 0.89). Extra support by both lay and professionals had a positive impact on breastfeeding outcomes. Maternal satisfaction was poorly reported.

Authors' conclusions

All women should be offered support to breastfeed their babies to increase the duration and exclusivity of breastfeeding. Support is likely to be more effective in settings with high initiation rates, so efforts to increase the uptake of breastfeeding should be in place. Support may be offered either by professional or lay/peer supporters, or a combination of both. Strategies that rely mainly on face-to-face support are more likely to succeed. Support that is only offered reactively, in which women are expected to initiate the contact, is unlikely to be effective; women should be offered ongoing visits on a scheduled basis so they can predict that support will be available. Support should be tailored to the needs of the setting and the population group.

Résumé scientifique

Prise en charge des mères allaitantes en bonne santé avec des bébés nés à terme et en bonne santé

Contexte

Il existe des preuves probantes selon lesquelles l'absence d'allaitement expose la santé des nouveau-nés et des mères à des risques importants. En 2003, l'Organisation Mondiale de la Santé recommandait que les nouveau-nés soient exclusivement allaités jusqu'à l'âge de six mois avec poursuite de l'allaitement comme élément important du régime alimentaire du nouveau-né jusqu'à au moins l'âge de deux ans. Toutefois, à l'heure actuelle, les taux d'allaitement ne reflètent pas cette recommandation dans de nombreux pays.

Objectifs

Évaluer l'efficacité de la prise en charge des mères allaitantes.

Stratégie de recherche documentaire

Nous avons effectué des recherches dans le registre des essais du groupe Cochrane sur la grossesse et la naissance (3 octobre 2011).

Critères de sélection

Des essais contrôlés randomisés ou quasi randomisés comparant une prise en charge supplémentaire des mères allaitantes en bonne santé de bébés nés à terme et en bonne santé à des soins maternels standard.

Recueil et analyse des données

Deux auteurs de la revue ont indépendamment évalué la qualité méthodologique des essais et extrait des données.

Résultats principaux

Sur les 67 études que nous avons évaluées comme étant éligibles pour l'inclusion, 52 ont fourni des données de résultat pour cette revue (56 451 paires mère - nouveau-né) et provenaient de 21 pays différents. Toutes les formes de prise en charge supplémentaire analysées montraient une augmentation de la durée de l'allaitement quel qu'il soit (inclut l'allaitement partiel et exclusif) (risque relatif (RR) de l'arrêt de l'allaitement avant six mois 0,91, intervalle de confiance (IC) à 95 % 0,88 à 0,96). Toutes les formes de prise en charge supplémentaire avaient des effets positifs sur la durée de l'allaitement exclusif (RR à six mois 0,86, IC à 95 % 0,82 à 0,91 ; RR de quatre à six semaines 0,74, IC à 95 % 0,61 à 0,89). La prise en charge supplémentaire assurée par les aidants et les professionnels avait un effet positif sur les résultats liés à l'allaitement. La satisfaction maternelle était mal signalée.

Conclusions des auteurs

Toutes les femmes doivent pouvoir bénéficier d'une prise en charge pour allaiter leurs bébés afin d'augmenter la durée et l'exclusivité de l'allaitement. Cette prise en charge aura plus de chances d'être efficace dans des lieux où les taux d'initiation sont élevés. Des efforts visant à augmenter le recours à l'allaitement doivent donc être implantés. Un professionnel ou un aidant/collègue, ou une combinaison des deux, peut proposer cette prise en charge. Les stratégies reposant principalement sur une prise en charge face à face ont plus de chances de réussir. Une prise en charge qui est uniquement proposée de façon réactive, pour laquelle les femmes doivent initier le contact, a peu de chances d'être efficace ; les femmes doivent pouvoir bénéficier de visites permanentes et planifiées afin de prévoir la disponibilité de la prise en charge qui doit être adaptée aux besoins du lieu et du groupe de population.

摘要

針對有健康滿月嬰兒的健康母乳哺餵母親的支持

背景

有廣泛的證據顯示: 若沒有母乳哺餵,對嬰兒與母親而言有重要健康風險。於2003年,世界衛生組織建議: 嬰兒六個月前採全母乳,並以持續母乳哺餵做為嬰兒飲食的主要部分直到至少兩歲。然而,在許多國家的母乳哺餵率並沒有反應此項建議。

目的

評估對母乳哺餵母親支持的有效性

搜尋策略

我們搜尋了考科藍孕期與出生群組試驗註冊 (the Cochrane Pregnancy and Childbirth Group's Trials Register) (2011年10月3日)

選擇標準

隨機或類隨機對照試驗,比較母乳哺餵健康滿月嬰兒的健康母親額外支持與一般產婦照護之效果。

資料收集與分析

兩位文獻回顧作者獨立評估試驗品質,並進行資料擷取。

主要結果

67個我們評估為合格採用的研究中,來自21國的52個研究對文獻回顧提供了成果相關資料(56,451 母嬰組)。所有形式額外的支持均一起分析,結果顯示: 在生產後6個月內,停止任何形式的母乳哺餵上,支持介入措施增加”任何母乳哺餵”的期間(包含部分與全母乳),風險比(risk ratio, RR) 0.91, 95%信賴區間(CI) 0.88 到0.96。所有形式的額外支持也在全母乳哺餵期間的延長上有正面影響 (RR 於6個月時 0.86, 95% CI 0.82 到0.91; RR 於4到6周時 0.74, 95% CI 0.61 到0.89)。由一般與專家提供的額外支持在母乳哺餵成果上都有正面影響。

作者結論

應提供所有母親以母乳哺餵嬰兒的支持,以增加全母乳哺餵的期間。支持可能可以讓有較高開始率的環境更為有效,所以應適當的在增加母乳攝取上進行努力。支持可以由專業人員或是一般/同儕支持者提供、或結合兩者。以面對面支持做為主要策略時,更有可能成功。僅以反應式的方式提供的支持,也就是預期由婦女先行開始的聯繫較不太可能有效;應提供婦女定期的、持續性的訪視,如此,她們較能預測將獲得支持。支持也應根據環境及人口群組的需求量身訂做。

Plain language summary

Support for breastfeeding mothers

The World Health Organization recommends that infants should be exclusively breastfed until six months of age with breastfeeding continuing as an important part of the infant’s diet till at least two years of age. This is because there is extensive evidence on the short-term and long-term health risks of not breastfeeding for both infants and their mothers. Many mothers stop breastfeeding before they want to as a result of problems, many of which are preventable with good care and support. This premature discontinuation may cause disappointment and distress for the mothers and health problems for both themselves and their infants. Support for breastfeeding can include giving reassurance, praise, information, and the opportunity to discuss and to respond to a mother’s questions. This review looked at whether providing extra support for breastfeeding mothers, from professionals or from trained lay people or both, would help mothers to continue to breastfeed when compared with providing standard maternity care. The review found 52 randomised controlled studies from 21 countries that included more than 56,000 women. All forms of extra support, analysed together, showed an increase in the length of time women continued to breastfeed and the length of time women breastfed without introducing any other types of liquids or foods. Support by both lay supporters and professionals had a positive impact on breastfeeding outcomes. Face-to-face support was associated with a larger treatment effect than telephone support. Support that is only offered if women seek help is unlikely to be effective. This indicates that women should be offered predictable, scheduled, ongoing visits. Interventions providing extra support had a more pronounced effect when background rates of breastfeeding initiation were high. Women's views about support interventions were not well reported in these studies. Support should be tailored to the setting and the needs of the population group. Further research is needed to identify the aspects of support that are the most effective.

Résumé simplifié

Prise en charge des mères allaitantes

L'Organisation Mondiale de la Santé recommande que les nouveau-nés soient exclusivement allaités jusqu'à l'âge de six mois avec poursuite de l'allaitement comme élément important du régime alimentaire du nouveau-né jusqu'à au moins l'âge de deux ans. Cette recommandation a été émise car il existe des preuves probantes de risques à court et long terme sur la santé des nouveau-nés et de leurs mères liés à l'absence d'allaitement. De nombreuses mères cessent prématurément d'allaiter en raison de problèmes, dont bon nombre peuvent être évités grâce à des soins et une prise en charge adaptés. Cet arrêt prématuré peut être source de déception et d'angoisse pour les mères, mais aussi de problèmes de santé pour leurs nouveau-nés et elles-mêmes. Une prise en charge de l'allaitement peut inclure des conseils visant à rassurer, à complimenter et à informer, mais c'est aussi une occasion de discuter et de répondre à des questions posées par la mère. La présente revue a examiné si une prise en charge supplémentaire pour les mères allaitantes, assurée par des professionnels et/ou des aidants ayant suivi une formation, permettait aux mères de continuer à allaiter comparée à la mise à disposition de soins de maternité standard. La revue a identifié 52 études contrôlées randomisées issues de 21 pays incluant plus de 56 000 femmes. Toutes les formes de prises en charge supplémentaires analysées montraient une augmentation de la durée d'allaitement et de la durée d'allaitement sans introduire d'autres types de liquides ou d'aliments. La prise en charge assurée par les aidants et les professionnels avait un effet positif sur les résultats liés à l'allaitement. Une prise en charge face à face était associée à un effet plus important du traitement par rapport à une prise en charge par téléphone. Cette prise en charge, uniquement proposée si les femmes recherchent une aide, a peu de chances d'être efficace. Cette indication signifie que les femmes doivent pouvoir bénéficier de visites prévisibles, planifiées et permanentes. Les interventions fournissant une prise en charge supplémentaire avaient des effets plus significatifs lorsque les taux de base d'initiation à l'allaitement étaient élevés. Les avis des femmes concernant les interventions de prise en charge n'étaient pas correctement signalés dans ces études. La prise en charge doit être adaptée au lieu et aux besoins du groupe de population. D'autres recherches seront nécessaires afin d'identifier les éléments les plus efficaces de la prise en charge.

Notes de traduction

Traduit par: French Cochrane Centre 8th June, 2012
Traduction financée par: Ministère du Travail, de l'Emploi et de la Santé Français

淺顯易懂的口語結論

母乳哺餵母親的支持

世界衛生組織建議嬰兒應在6個月前採全母乳哺餵,並且將母乳哺餵持續做為嬰兒飲食的重要部分直到2歲。這是因為有廣泛的證據顯示不以母乳哺餵在短期與長期健康風險中對嬰兒及母親都有影響。許多母親在預計停止母乳哺餵前因為許多問題而停止,這些問題中有許多是可以利用良好照護及支持而避免的。過早的中斷母乳哺餵,可能造成母親的失望與痛苦,並對母親本身及嬰兒帶來健康問題。支持母乳哺餵包含提供安慰、讚美、資訊以及討論及回應母親問題的機會。與提供標準產後照護相比,此文獻回顧觀察提供母乳哺餵母親額外支持是否能協助母親繼續母乳哺餵,額外支持可來自專家或是受訓的一般民眾或同時由兩者提供支持。 文獻回顧找到52個來自21個國家的隨機對照試驗,其包含了超過56,000名婦女。在所有的額外支持形式都一起分析下顯示: 在婦女持續母乳哺餵以及婦女無採用任何其它液體類型或食物的時間長度上有增加的情形。同時由支持者及專家提供支持在母乳哺餵成果上有正面影響。面對面支持與較大的治療效果有關,較電話支持效果好。僅在父母尋求協助時提供的支持不太可能產生效果。這表示應提供婦女可預測、計畫中、持續性的拜訪。當母乳哺餵開始的普遍率高的時候,提供額外支持的介入措施有較多的顯著影響。婦女看待支持介入措施的角度沒有在這些研究中被適當的呈現出來。支持應根據環境及人口群組的需求而量身訂做。需要額外的研究找出最有效的支持面向。

譯註

翻譯: East Asian Cochrane Alliance
翻譯補助: 此翻譯計畫由臺灣行政院衛生福利部經費補助,臺北醫學大學實證醫學研究中心統籌。

Ringkasan bahasa mudah

Sokongan untuk ibu-ibu yang menyusu bayi

Pertubuhan Kesihatan Sedunia (WHO) mencadangkan bahawa bayi harus diberi susu ibu secara eksklusif sehingga usia 6 bulan. Selepas itu, penyusuan harus diberi secara berterusan sebagai satu komponen penting dalam pemakanan bayi sehingga sekurang-kurangnya usia 2 tahun. Ini adalah kerana terdapat bukti yang banyak mengenai risiko jangka pendek dan panjang terhadap ibu dan bayi jika ibu tidak memberi penyusuan. Ramai ibu menghentikan penyusuan sebelum mereka mempunyai keinginan kerana masalah-masalah yang kebanyakkannya boleh dielakkan dengan penjagaan dan sokongan yang baik. Penamatan awal penyusuan boleh menyebabkan kecewaan dan kesedihan untuk ibu dan boleh menjejaskan kesihatan ibu dan bayi. Antara cara-cara sokongan termasuklah memberi keyakinan, pujian, maklumat, dan peluang untuk berbincang dan menjawab soalan-soalan ibu. Ulasan ini melihat sama ada penyediaan sokongan tambahan untuk ibu oleh profesional atau orang awam terlatih atau kedua-duanya boleh membantu ibu untuk terus menyusu apabila dibandingkan dengan penjagaan bersalin berpiawaian. Ulasan ini mendapat 52 kajian rambang terkawal yang meliputi lebih daripada 56,000 wanita. Apabila semua bentuk sokongan tambahan dikaji bersama-sama, tempoh masa penyusuan ibu dan tempoh masa penyusuan yang tidak memerlukan cecair atau makanan lain untuk bayi telah meningkat. Sokongan yang diberi oleh orang awam dan profesional boleh memberi kesan yang positif kepada pencapaian tempoh penyusuan. Sokongan yang diberi secara bersemuka telah dikaitkan dengan kesan rawatan yang baik berbanding dengan sokongan melalui telefon. Sokongan yang hanya ditawarkan kepada wanita yang ingin mendapatkan bantuan berkemungkinan adalah tidak berkesan. Ini menunjukkan bahawa wanita harus ditawarkan lawatan berterusan yang boleh diramal dan dijadualkan. Intervensi yang menyediakan sokongan tambahan boleh memberi kesan yang lebih ketara apabila terdapat latar berlakang yang menunjukkan kadar permulaan penyusuan yang tinggi. Akan tetapi, pandangan wanita mengenai intervensi sokongan ini tidak dilaporkan dengan baik dalam kajian-kajian tersebut. Sokongan tersebut perlu disesuaikan dengan suasana dan keperluan kumpulan penduduk. Oleh itu, kajian lanjutan diperlukan untuk mengenal pasti aspek sokongan yang paling berkesan.

Catatan terjemahan

Diterjemahkan oleh Raymond Chieng Siang Ching, Melaka Manipal Medical College. Untuk sebarang pertanyaan mengenai terjemahan ini sila hubungi raymondchieng@gmail.com

Laički sažetak

Najbolji oblik podrške za dojilje

Svjetska zdravstvena organizacija preporučuje ekskluzivno dojenje novorođenčadi tijekom prvih 6 mjeseci života, nakon čega bi dojenje također trebalo nastaviti kao važan dio djetetove prehrane najmanje do druge godine života. Razlozi za takvu preporuku leže u nizu dokaza koji pokazuju da izostanak dojenja uzrokuje različite kratkoročne i dugoročne rizike i kod majke i kod djeteta. Brojne žene prestanu dojiti prije nego to žele zbog niza problema, od kojih se mnogi mogu spriječiti dobrom skrbi i podrškom. Takvo preuranjeno prekidanje dojenja može uzrokovati razočaranje i stres kod majke te zdravstvene probleme i kod majke i kod djeteta. Podrška za dojilje uključuje davanje podrške, pohvale, informacija i priliku za razgovor i odgovaranje na pitanja. Ovaj Cochrane sustavni pregled je analizirao kliničke pokuse provedene na tu temu kako bi se ispitalo da li pružanje dodatne podrške dojiljama, od strane zdravstvenih radnika ili educiranih laika, može pomoći dojiljama da nastave dojiti u usporedbi sa standardnom skrbi za dojilje. U sustavni pregled uključeno je 52 randomiziranih kontroliranih studija (u kojima su ispitanice nasumično podijeljene u više skupina) koje su provedene u 21 zemlje i u koje je bilo uključeno više od 56.000 žena. Kad su analizirani zajedno svi oblici dodatne podrške pokazali su povećanje duljine vremena tijekom kojeg je žena nastavila dojiti i duljine vremena tijekom kojeg je žena dojila bez uvođenja drugih vrsta tekućine ili hrane. Podrška educiranih laika, kao i zdravstvenih radnika, imala je pozitivan učinak na pokazatelje dojenja. Osobna podrška licem u lice imala je veći učinak nego podrška preko telefona. Nije vjerojatno da je učinkovita podrška koja se pruža samo onda kad je žena zatraži. Ti rezultati pokazuju da bi se ženama koje doje trebalo omogućiti zakazane i kontinuirane posjete osoba koje joj mogu pružiti podršku u dojenju. Intervencije koje uključuju dodatnu podršku imale su veći efekt kad su stope početka dojenja bile velike. Stavovi žena o intervencijama za podršku dojenju nisu dobro opisani u pronađenim studijama. Podršku dojiljama trebalo bi prilagoditi pojedinom okruženju i potrebama pojedinih skupina stanovništva. Potrebna su daljnja istraživanja kako bi se utvrdilo koji su vidovi podrške bili najdjelotvorniji.

Bilješke prijevoda

Hrvatski Cochrane
Prevela: Livia Puljak
Ovaj sažetak preveden je u okviru volonterskog projekta prevođenja Cochrane sažetaka. Uključite se u projekt i pomozite nam u prevođenju brojnih preostalih Cochrane sažetaka koji su još uvijek dostupni samo na engleskom jeziku. Kontakt: cochrane_croatia@mefst.hr

எளியமொழிச் சுருக்கம்

தாய் பாலூட்டும் தாய்களுக்கான ஆதரவு

பச்சிளங் குழந்தைகள் ஆறு மாத வயது வரை பிரத்தேயகமாக தாய் பாலூட்டப்பட வேண்டும் மற்றும் இரண்டு வருட வயது வரை பச்சிளங் குழந்தையின் உணவுத் திட்டத்தில் ஒரு முக்கியமான அங்கமாக தாய்ப்பால் தொடரப்படவேண்டும் என்று உலக சுகாதார நிறுவனம் பரிந்துரைக்கிறது. தாய் பாலுட்டாமல் இருப்பது, பச்சிளங் குழந்தைகள் மற்றும் அவர்களின் தாய்மார்களுக்கு குறுகிய-கால மற்றும் நீண்ட-கால ஆரோக்கிய அபாயத்தை ஏற்படுத்தும் என்பதற்கு அதிகளவிலான ஆதாரம் இருப்பதே இதற்கு காரணமாகும். நல்ல பராமரிப்பு மற்றும் ஆதரவுடன் தடுக்கப்பட முடிந்த பெரும்பாலான பிரச்னைகளால், பல தாய்மார்கள் தேவைப்படுவதற்கு முன்பதாகவே பாலூட்டுவதை நிறுத்துவர். இந்த குறித்த காலத்திற்கு முந்தைய தொடராமை, தாய்மார்களுக்கு ஏமாற்றம் மற்றும் வேதனையை ஏற்படுத்தக் கூடும் மற்றும் அவர்களுக்கும் பச்சிளங் குழந்தைகளுக்கும் ஆரோக்கிய பிரச்னைகளை ஏற்படுத்தும். மறுநம்பிக்கை, புகழ்ச்சி, தகவல், மற்றும் கலந்துரையாடுவதற்கு ஒரு வாய்ப்பு தருதல் மற்றும் தாயின் கேள்விகளுக்கு பதிலளித்தல் ஆகியவை பாலூட்டுவதற்கான ஆதரவில் அடங்கும். வழக்கமான மகப்பேறு பராமரிப்பை ஒப்பிடுகையில், தொழில் வல்லுநர்கள் அல்லது பயிற்சியளிக்கப்பட்ட பொது மக்கள் அல்லது இருவர் மூலம் பாலூட்டும் தாய்களுக்கு வழங்கப்படும் கூடுதலான ஆதரவு, தாய்மார்கள் அவர்கள் தாய்பாலூட்டுவதை தொடர உதவுமா என்பதை இந்த திறனாய்வு கண்டது. 21 நாடுகளிலிருந்து, 56,000-க்கும் அதிகமான பெண்களை சேர்த்திருந்த 52 சீரற்ற கட்டுப்படுத்தப்பட்ட சோதனைகளை இந்த திறனாய்வு கண்டது. அனைத்து வகையான கூடுதல் ஆதரவின் கூட்டு பகுப்பாய்வு, பெண்கள் தாய்பாலூட்டுவதை தொடர்ந்த கால அளவின் அதிகரிப்பையும் எனவும் மற்றும் பிற வகையான திரவங்கள் அல்லது உணவுகளை அறிமுகப்படுத்தாமல் தாய்பாலூட்டுவதை தொடர்ந்த கால அளவின் அதிகரிப்பையும் காட்டின. தொழில் வல்லுநர்கள் அல்லது பயிற்சியளிக்கப்பட்ட பொது மக்கள் மூலம் அளிக்கப்பட்ட ஆதரவு, தாய்பாலூட்டல் விளைவுகளின் மேல் ஒரு நேர்மறையான தாக்கத்தை ஏற்படுத்தியது. தொலைபேசி ஆதரவை விட, முக-முகமாய் அளிக்கப்பட்ட ஆதரவு பெரியளவு சிகிச்சை விளைவோடு சம்பந்தப்பட்டிருந்தது. பெண்கள் உதவி தேடும் போது மட்டும் அளிக்கப்பட்ட ஆதரவு திறனுடையதாக இருப்பதற்கு சாத்தியமில்லை. எதிர்பார்ப்போடு, அட்டவணையோடு, மற்றும் தொடரப்பட்ட சந்தித்தல்களோடு பெண்களுக்கு ஆதரவு அளிக்கப்பட வேண்டும் என்பதை சுட்டிக்காட்டுகிறது. தாய் பாலூட்டும் ஆரம்ப முயற்சிகளின் பின்புல நிகழ்வுகள் அதிகமாக இருந்த போது, கூடுதலான ஆதரவை வழங்கும் சிகிச்சை தலையீடுகள் முனைப்பான விளைவை கொண்டிருந்தன. இந்த ஆய்வுகளில், ஆதரவு சிகிச்சை தலையீடுகள் பற்றி பெண்களின் கருத்துகள் சரிவர அறிக்கையிடப்படவில்லை. அமைப்பிற்கு மற்றும் மக்கள் குழுவின் தேவைகளுக்கு ஏற்றவாறு ஆதரவு இருக்க வேண்டும். ஆதரவின் எந்த வகையான கூறுகள் மிகவும் திறன் மிக்கவையாக இருக்கும் என்பதை கண்டறிவதற்கு மேற்படியான ஆராய்ச்சி தேவைப்படுகிறது.

மொழிபெயர்ப்பு குறிப்புகள்

மொழிபெயர்ப்பாளர்கள்: சிந்தியா ஸ்வர்ணலதா ஸ்ரீகேசவன், தங்கமணி ராமலிங்கம், ப்ளசிங்டா விஜய், ஸ்ரீகேசவன் சபாபதி.

Background

Breastfeeding has a fundamental impact on the short-, medium- and long-term health of children and has an important impact on women’s health. Good quality evidence demonstrates that in both low- and high-income settings not breastfeeding contributes to infant mortality, hospitalisation for preventable disease such as gastroenteritis and respiratory disease, increased rates of childhood diabetes and obesity, and adult disease such as coeliac and cardiovascular disease, as well as increased risks of breast cancer and diabetes in the mother (Black 2008; Ip 2007; Horta 2007; Quigley 2007), and reduced birth spacing when other forms of contraception are not available (Thapa 1988). Not being breastfed has an impact on IQ, and educational and behavioural outcomes for the child (Heikkilä 2011; Quigley 2012). For many outcomes a dose-response relationship exists, with the greatest benefit resulting from breastfeeding exclusively, with no added food or fluids, for around six months, with breastfeeding continuing thereafter as an important component of the infant’s diet (Kramer 2002; Raisler 1999). The negative impact of not breastfeeding has been demonstrated in a range of settings and population groups, though the balance of risks and benefits varies from setting to setting; gastroenteritis will result in much higher mortality in low-income countries, for example (Black 2008; Victora 2008). 

Few health behaviours have such a broad-spectrum and long-lasting impact on population health, with the potential to improve life chances, health and wellbeing. The cost burden of not breastfeeding is significant and includes the cost of caring for children and women with chronic disease as well as short-term illness (Bartick 2010; Smith 2010). 

The established negative impact on a population of not breastfeeding has resulted in global and national support for encouraging the initiation and continuation of breastfeeding. The World Health Organization (WHO) recommends that, wherever possible, infants should be fed exclusively on breast milk until six months of age (WHO 2003), with breastfeeding continuing as an important part of the infant’s diet till at least two years of age. Other agencies and countries have endorsed the recommendation to breastfeed exclusively to around six months of age (e.g. CDC 2010; DoH 2003; EFSA Panel 2009).

Although some high-income countries such as Scandinavia, Germany, and Norway have high rates of both initiation and continuation of breastfeeding (Cattaneo 2003; Nicoll 2002), rates in many high-income countries are low. Initiation rates have risen in some high-income countries in recent years (e.g. NHS 2011; USDoHHS 2005), but there remains a marked decline in breastfeeding within the first few weeks after initiation, and exclusive breastfeeding is rare (Bolling 2007). In middle- and low-income countries, exclusive breastfeeding is far from universal, with urban areas often showing lower rates than rural areas (WHO 2011). This is particularly important as when breastfeeding continues for long periods of time, infant and young child mortality are reduced in the second year of life in low- and middle-income countries (WHO 2000).

The early discontinuation of breastfeeding is not a decision that is taken lightly by women; it is associated with a high prevalence of problems such as painful breasts and nipples, concern about adequacy of milk supply and about the baby’s behaviour, and embarrassment related to breastfeeding in public; and many mothers report distress related to the decision to discontinue breastfeeding (e.g. Bolling 2007), even in cultures where breastfeeding rates are high (Almqvist 2011).  A key factor is the widespread lack of appropriate education for health professionals in the prevention and treatment of breastfeeding problems, which means that in a wide range of settings women commonly do not receive the care needed from the health services (EU 2008; Renfrew 2006). 

Infant feeding is strongly related to inequalities in health and far from being an individual decision made by each woman, is influenced most strongly by structural determinants of health. The range of different rates of initiation and continuation of breastfeeding in different settings globally demonstrates that the key factors influencing infant feeding rates are likely to be socio-cultural and related to societal norms, public policy, and the availability of appropriate care and support, both professional and lay (EU 2008). In high-income countries, for example, young mothers and women in low-income groups, or women who ceased full-time education at an early age, are least likely either to start breastfeeding or to continue for a period of time sufficient to benefit from the greatest health gain (Bolling 2007). Enkin 2000 notes that industrial societies, on the whole, do not provide women with the opportunity to observe other breastfeeding women before they attempt breastfeeding themselves. In such societies, where breastfeeding is not normative behaviour and women may find it socially challenging to breastfeed, women are at particular risk of finding a serious lack of support to continue breastfeeding.  Migrant women have been shown to adopt breastfeeding practices that are more similar to the country in which they live, than the country of their birth (e.g. McLachlan 2006). Rates in low-income countries also vary widely, especially rates of exclusive breastfeeding (WHO 2011).

In few settings is standard care offered by professionals with an in-depth understanding of the prevention and treatment of breastfeeding problems. To address this, UNICEF and the WHO established the global Baby Friendly Hospital Initiative (Baby Friendly Initiative in some countries) in 1991 to train health professionals and remove inappropriate routines such as supplementary feeding and restrictions on feeding times. Over 15,000 facilities in 134 countries have been accredited (UNICEF 2011), but most babies are still not born in a Baby Friendly environment. 

It is therefore fundamentally important to examine the support that mothers receive when breastfeeding to determine what might be effective in helping women continue to breastfeed, whatever setting they live in.  ‘Support’ can include several elements, including reassurance, praise, information, the opportunity to discuss and to respond to the mother’s questions.  It can be offered in a range of ways, by health professionals or lay people, trained or untrained, in hospital and community settings.  It can be offered to groups of women or one-to-one, it can involve mother-to-mother support, and it can be offered proactively by contacting women directly, or reactively, by waiting for women to get in touch.  It can be provided face-to-face or over the phone, and it can involve only one contact or regular, ongoing contact over several months.  Support is a complex intervention that tackles the multifaceted challenge of enabling women to breastfeed, and it should not be surprising that it varies from setting to setting and from study to study. However, it is likely that different forms of support in different contexts will be differentially effective. Whilst many support interventions include breastfeeding education for mothers, our review excludes interventions described as solely educational in nature and interventions with no postnatal component. A Cochrane review of antenatal breastfeeding education for increasing breastfeeding duration has recently been published (Lumbiganon 2011).

The purpose of this review is to examine interventions which provide extra support for mothers who are breastfeeding or considering breastfeeding; and to assess their impact on breastfeeding duration and exclusivity and, where recorded, on health outcomes and maternal satisfaction. The focus of this review is support for mothers and babies who are part of the general healthy population of their countries; mothers of premature and sick babies and mothers with some medical conditions have additional issues with breastfeeding, and interventions to support these mothers need to be reviewed separately. Specific objectives of this review were to describe forms of support which have been evaluated in controlled studies, and the settings in which they have been used. It was also of interest to examine the effectiveness of different modes of offering similar supportive interventions (for example, face-to-face or over the telephone), whether interventions containing both antenatal and postnatal elements were more effective than those taking place in the postnatal period alone, and whether the support was offered proactively to women, or whether they needed to seek it out. We also planned to examine the effectiveness of different care providers and the possible impact of background breastfeeding rates in the countries or areas where the trials took place on the effectiveness of supportive interventions. It is important to note that the support interventions offered were in addition to standard care, which varied from setting to setting, though in few settings is standard care offered by people with training and skill in enabling women to breastfeed.

Objectives

  1. To describe forms of breastfeeding support which have been evaluated in controlled studies, the timing of the interventions and the settings in which they have been used.

  2. To examine the effectiveness of different modes of offering similar supportive interventions (for example, whether the support offered was proactive or reactive, face-to-face or over the telephone), and whether interventions containing both antenatal and postnatal elements were more effective than those taking place in the postnatal period alone.

  3. To examine the effectiveness of different care providers and (where information was available) training.

  4. To explore the interaction between background breastfeeding rates and effectiveness of support.

Methods

Criteria for considering studies for this review

Types of studies

All randomised or quasi-randomised controlled trials, with or without blinding.

Types of participants

Participants were women breastfeeding their babies. Studies that recruited pregnant women considering or intending to breastfeed were included if the intervention included breastfeeding support after the birth.

Types of interventions

Contact with an individual or individuals (either professional or volunteer) offering support which is supplementary to the standard care offered in that setting. ‘Support’ interventions eligible for this review could include elements such as reassurance, praise, information, and the opportunity to discuss and to respond to the mother’s questions, and it could also include staff training to improve the supportive care given to women. It could be offered by health professionals or lay people, trained or untrained, in hospital and community settings. It could be offered to groups of women or one-to-one, including mother-to-mother support, and it could be offered proactively by contacting women directly, or reactively, by waiting for women to get in touch. It could be provided face-to-face or over the phone, and it could involve only one contact or regular, ongoing contact over several months. Studies were included if the intervention occurred in the postnatal period alone or also included an antenatal component. Interventions taking place in the antenatal period alone were excluded from this review, as were interventions described as solely educational in nature.

Types of outcome measures

The main outcome measure was the effect of the interventions on stopping breastfeeding by specified points in time. Primary outcomes were recorded for stopping any or exclusive breastfeeding before four to six weeks and at the last study assessment (up to six months). Other outcomes of interest were stopping any or exclusive breastfeeding at other time points (two, three, four, nine and 12 months), measures of neonatal and infant morbidity (where available) and measures of maternal satisfaction with care or feeding method.

Primary outcomes
  1. Stopping breastfeeding before six months postpartum.

  2. Stopping exclusive breastfeeding before six months postpartum.

  3. Stopping any breastfeeding before four to six weeks postpartum.

  4. Stopping exclusive breastfeeding before four to six weeks postpartum.

Secondary outcomes
  1. Stopping breastfeeding before two, three, nine and 12 months postpartum.

  2. Stopping exclusive breastfeeding before two, three, nine and 12 months postpartum.

  3. Maternal satisfaction with care.

  4. Maternal satisfaction with feeding method.

  5. All-cause infant or neonatal morbidity.

Search methods for identification of studies

Electronic searches

We searched the Cochrane Pregnancy and Childbirth Group's Trials Register by contacting the Trials Search Co-ordinator (3 October 2011).

The Cochrane Pregnancy and Childbirth Group’s Trials Register is maintained by the Trials Search Co-ordinator and contains trials identified from: 

  1. quarterly searches of the Cochrane Central Register of Controlled Trials (CENTRAL);

  2. weekly searches of MEDLINE;

  3. weekly searches EMBASE;

  4. handsearches of 30 journals and the proceedings of major conferences;

  5. weekly current awareness alerts for a further 44 journals plus monthly BioMed Central email alerts.

Details of the search strategies for CENTRAL, MEDLINE and EMBASE, the list of handsearched journals and conference proceedings, and the list of journals reviewed via the current awareness service can be found in the ‘Specialized Register’ section within the editorial information about the Cochrane Pregnancy and Childbirth Group

Trials identified through the searching activities described above are each assigned to a review topic (or topics). The Trials Search Co-ordinator searches the register for each review using the topic list rather than keywords. 

Trials identified through the searching activities described above are given a code (or codes) depending on the topic. The codes are linked to review topics. The Trials Search Co-ordinator searches the register for each review using these codes rather than keywords.

In previous versions of the review, we carried out additional searches of MEDLINE (1966 to November 2005), EMBASE (1974 to November 2005) and handsearched Midwives Information and Resource Service (MIDIRS) quarterly Digest from 1991 to September 2005. We scanned secondary references and obtained relevant studies. Details of the search strategies can be obtained from the review authors. In this updated version of the review we did not carry out these additional searches.

We did not apply any language restrictions.

Data collection and analysis

For the methods used when assessing the trials identified in previous versions of this review, see Appendix 1.

Selection of studies

In this update, two review authors (B Quinn and T Dowswell) independently assessed all the studies identified as a result of the search strategy for possible inclusion in the review. We resolved any disagreement through discussion or, if required, we consulted a third review author (F McCormick or M Renfrew).

Data extraction and management

We designed and piloted a form to extract data. For eligible studies, two review authors extracted information using the agreed form. We resolved discrepancies through discussion. Data were entered into Review Manager software (RevMan 2011), and checked for accuracy.

When information regarding study methods and results were unclear, we attempted to contact authors of the original reports to provide further details.

Assessment of risk of bias in included studies

Two review authors independently assessed risk of bias for each study using the criteria outlined in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). Any disagreement was resolved by discussion or by involving a third assessor.

(1) Sequence generation (checking for possible selection bias)

We have described for each included study the method used to generate the allocation sequence and assessed whether it was likely to produce comparable groups.

We assessed the method as:

  • low risk of bias (any truly random process, e.g. random number table; computer random number generator);

  • high risk of bias (any non random process, e.g. odd or even date of birth; hospital or clinic record number);

  • unclear risk of bias.   

 (2) Allocation concealment (checking for possible selection bias)

We have described for each included study the method used to conceal the allocation sequence and assessed whether the treatment allocation could have been foreseen in advance of, or during recruitment, or changed after assignment.

We assessed the methods as:

  • low risk of bias (e.g. telephone or central randomisation; consecutively numbered sealed opaque envelopes);

  • high risk of bias (open random allocation; unsealed or non-opaque envelopes, alternation; date of birth);

  • unclear risk of bias.   

(3) Blinding (checking for possible performance or detection bias)

For this type of intervention, blinding women and clinical staff is generally not feasible, although it may be possible to blind outcome assessors. We have assessed blinding for outcome assessors as:

  • low, high or unclear risk of bias.

(4) Incomplete outcome data (checking for possible attrition bias through withdrawals, dropouts, protocol deviations)

In studies examining breastfeeding support women may be followed up over many months and loss to follow-up over time may mean that studies are at high risk of bias. We have described for each included study the completeness of data including attrition and exclusions from the analysis. We have reported the numbers included in the analysis at each stage (compared with the total randomised participants), reasons for attrition or exclusion where reported, and whether missing data were balanced across groups or were related to outcomes. We assessed methods as:

  • low, high or unclear risk of bias.

We have not included outcome data in the analyses if there was more than 25% missing data for that outcome. Several studies which were otherwise eligible for inclusion in the review have not contributed any outcome data due to post randomisation exclusions and loss to follow-up which resulted in more than 25% missing data for all outcomes reported.

(5) Selective reporting bias

We have described for each included study whether we suspected any selective outcome reporting bias.

We assessed the methods as:

  • low risk of bias (where it is clear that all of the study’s pre-specified outcomes and all expected outcomes of interest to the review have been reported);

  • high risk of bias (where not all the study’s pre-specified outcomes have been reported; one or more reported primary outcomes were not pre-specified; outcomes of interest are reported incompletely and so cannot be used; study failed to include results of a key outcome that would have been expected to have been reported);

  • unclear risk of bias.

(6) Other sources of bias

We have described for each included study any important concerns we had about other possible sources of bias.

We assessed whether each study was free of other problems that could put it at risk of bias:

  • yes (low risk of other bias);

  • no (high risk of other bias);

  • unclear risk of other bias.

(7) Overall risk of bias

We have made explicit judgements about whether studies are at high risk of bias, according to the criteria given in the Handbook (Higgins 2011). With reference to (1) to (6) above, we assessed the likely magnitude and direction of the bias, and whether we considered it was likely to impact on the findings. We explored the impact of possible bias through undertaking sensitivity analyses - see Sensitivity analysis

Overall findings for our assessment of risk of bias in the included studies are set out in Figure 1 and Figure 2.

Figure 1.

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Figure 2.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Measures of treatment effect

Dichotomous data

For dichotomous data, we have presented results as summary risk ratio with 95% confidence intervals (CI). 

Continuous data

For continuous data, we planned to use the mean difference if outcomes were measured in the same way between trials or the standardised mean difference to combine trials that measured the same outcome, but used different methods.  

Unit of analysis issues

Cluster-randomised trials

We have included eight cluster-randomised trials in the analyses along with individually randomised trials. Their sample sizes have been adjusted using the methods described in the Handbook (Higgins 2011) and by Donner 2000 using an estimate of the intracluster correlation co-efficient (ICC) derived from the trial (if possible), or from another source. If ICCs from other sources were used, we have noted this and carried out sensitivity analyses to investigate the effect of variation in ICC. We have synthesised the findings from individually- and cluster-randomised trials provided that there was little heterogeneity between the study designs. and the interaction between the effect of intervention and the choice of randomisation unit was considered to be unlikely.

Dealing with missing data

For included studies, we have noted levels of attrition. We have not included any outcomes in the analyses if there was more than 25% missing data.

For all outcomes we have carried out analyses, as far as possible, on an intention-to-treat basis, i.e. we attempted to include all participants randomised to each group in the analyses. For all primary outcomes the denominator for each outcome in each trial is the number of women randomised. We have assumed that all women who were lost to follow-up had stopped breastfeeding or stopped exclusive breastfeeding. This means that estimates of treatment effect may be diluted in studies where there has been moderate loss to follow-up.

Assessment of heterogeneity

We have use the I² and T² statistics to quantify heterogeneity along with the Chi² test for heterogeneity. If we identified substantial heterogeneity (I² greater than 30%), we have drawn attention to this in the text and have advised readers to interpret results with caution. For primary outcomes where moderate or high levels of heterogeneity were identified we have also given the 95% prediction interval which gives the range of effects expected across different settings (Riley 2011).

Assessment of reporting biases

Where we suspected reporting bias (see ‘Selective reporting bias’ above), we attempted to contact study authors asking them to provide missing outcome data.

For all outcomes we have ordered studies in terms of weight, and for primary outcomes, provided sufficient studies contributed data, we have generated funnel plots. We visually examined plots to see whether there was any evidence of asymmetry suggesting different treatment effects in smaller studies which may indicate publication bias (Harbord 2006).

Data synthesis

We carried out statistical analysis using the Review Manager software (RevMan 2011). At the outset, we had anticipated that there would be some heterogeneity between studies in terms of the interventions and the populations studied, we therefore decided to use random-effects meta-analysis for combining data. Random-effects meta-analysis estimates the average treatment effect and this may not always be clinically meaningful. Further, where there is high heterogeneity the applicability of the overall effect estimate is likely to vary in different settings and we therefore advise caution in the interpretation of results.

Subgroup analysis and investigation of heterogeneity

We planned to carry out the following subgroup analyses.

  1. By type of supporter (professional versus lay person, or both).

  2. By type of support (face-to-face versus telephone support).

  3. By timing of support (antenatal and postnatal versus postnatal alone).

  4. By whether the support was proactive (scheduled contacts) or reactive (women needed to request support).

  5. By background breastfeeding initiation rates (low, medium or high background rates).

  6. By intensity of support (number of scheduled contacts).

We have used primary outcomes only in subgroup analysis.

We visually examined the forest plots of subgroup analyses to look at whether there was overlap between 95% CIs for the effects in different groups; with non-overlapping CIs suggesting a difference between subgroups. We also conducted formal statistical analyses to examine any possible differences between subgroups classifying whole trials by interaction tests as described in the Handbook (Higgins 2011) and available in RevMan 2011; we have reported results of interaction tests in the text.

Sensitivity analysis

We have carried out sensitivity analysis for primary outcomes by study quality; we did this by dividing the studies into subgroups according to whether they were at low risk of bias as opposed to unclear or high risk of bias for allocation concealment to see what impact this would have on the treatment effect.

Results

Description of studies

The main purpose of this review was to analyse the impact of the intervention, extra breastfeeding support, compared with usual maternity care, with the purpose of facilitating continued breastfeeding. We included studies if the intervention occurred in the postnatal period alone or if it also included an antenatal component. We excluded interventions taking place in the antenatal period alone, as well as interventions described as solely educational in nature.

Primary outcomes were recorded for stopping any or exclusive breastfeeding before four to six weeks and at the last assessment up to six months Other outcomes of interest were stopping breastfeeding at other time points, measures of neonatal and infant morbidity (where available) and measures of maternal satisfaction with care or feeding method.

Results of the search

In the previous version of this review (Britton 2007), we included 34 trials. In this updated version, we assessed 218 reports; as several trials resulted in multiple publications this corresponded to 150 separate studies. We have included 67 studies and excluded 79. Three studies are still ongoing (Bonuck 2008; Eneroth 2007; Patel 2011) and one study is awaiting assessment (Nunes 2011) and we hope to include results from these in future updates (see Characteristics of studies awaiting classification, Characteristics of ongoing studies and Characteristics of studies awaiting classification tables for more information about these trials).

Of the 67 studies that we assessed as eligible for inclusion, 52 contributed outcome data to the review and have been included in the results. One of these trials reported results in three African countries, and in the data and analysis tables we have entered data for each country separately and have completed three Characteristics of included studies tables as there were some differences between the three countries in the characteristics of women recruited, and the way the intervention was delivered (Tylleskar 2011a; Tylleskar 2011b; Tylleskar 2011c).

We have not included outcome data from 10 studies where loss to follow-up was greater than 25% because the results from trials with high levels of attrition are difficult to interpret, and are liable to be at high risk of bias (Aidam 2005; Anderson 2005; Ellis 1984; Gross 1998; Hall 1978; Khresheh 2011; McKeever 2002; Redman 1995; Wambach 2009; Wolfberg 2004). We have not included data from a further five trials as data were not reported in a way that allowed us to enter them into RevMan 2011 (e.g. results were not reported by randomisation group) (Bloom 1982; Caldeira 2008; Chen 1993; Kaojuri 2009; Ransjo-Arvidson 1998); where possible we have contacted authors for more information and may be able to include data from these studies in future updates.

In the results section below we will not discuss further those 15 studies not contributing data to the review, but additional information about these trials is provided in the Characteristics of included studies tables.

Included studies

Description of included studies (n = 52)

Fifty-two included studies contribute data to this update of the review. The total number of mother-infant pairs in these studies is 56,451 (this total was 29,385 in the previous version of this review Britton 2007). The 52 studies were published/conducted between 1979 and 2011 and show increases over time both in number of studies (five studies are dated earlier than 1990, 10 are dated 1990 to 1999 and 37 are dated 2000 to 2011) and range of country settings (the seven studies with dates earlier than 1994 were all undertaken in high-income countries, and the four studies from low/low-middle income countries were published in 2000 or later). The data in this review come from participants living in 21 countries. Using the World Bank classification of countries by income (http://data.worldbank.org/about/country-classifications/country-and-lending-groups, accessed 25 Oct 2011):

 1 Note: The study by Tylleskar et al (Tylleskar 2011a; Tylleskar 2011b; Tylleskar 2011c) was undertaken in three countries, two in the low-income and one in the upper middle income World Bank category. In this review, we have entered data into the analyses separately for each country.

Methods used in trials

The 52 studies include 44 individually-randomised trials and eight cluster-randomised trials.

Participants and setting

Socio-economic and health status

Participants were women from the general healthy population of their countries. However, 19 of the 52 studies were undertaken with women from low-income groups within their country. These 19 studies include 12 of the 14 US studies, with two other studies from high-income countries (Jones 1985; Quinlivan 2003), three of the studies from Brazil (Barros 1994; Coutinho 2005; Vitolo 2005), and the two studies from low-income countries. In one of these (Haider 2000, Bangladesh), participants were mainly of lower-middle and low socio-economic status. In the other (Tylleskar 2011a; Tylleskar 2011b; Tylleskar 2011c), participants came from three countries in sub-Saharan Africa, with those in one country (Uganda) from low-income groups within that country. With regard to health of the general population of countries, this author notes local HIV prevalence rates of 10% to 34% in the South Africa study sites; during recruitment, women who had not been HIV tested were encouraged to visit the antenatal clinic, and those who disclosed HIV positive status were recruited into another study.

Background rates of breastfeeding initiation/“ever breastfed”

Among the 52 studies, World Bank country income group shows an inverse relationship with background rates of breastfeeding initiation ("ever breastfed"). All the studies with intermediate (60% to < 80%, n = 18) or low (< 60%, n = 11) background rates of breastfeeding initiation were undertaken in high-income countries. Nine of the 11 studies with low background rates recruited women from low-income groups in the US (Brent 1995; Bonuck 2005; Bunik 2007; Chapman 2004; Di Meglio 2010; Frank 1987; Grossman 1990; Pugh 2002; Serafino-Cross 1992); the remaining two (UK) studies were from areas of Scotland with lower breastfeeding initiation rates than the Scottish average (Hoddinott 2009; Muirhead 2006). All the country income groups are represented among the 24 studies with high (≥ 80%) rates, however the four studies from low-/low-middle-income countries all have very high rates (≥ 95% ever breastfed). Where background rates of “ever breastfed” were not reported, we have used rates published in The WHO Global Data Bank on Infant and Young Child Feeding http://www.who.int/nutrition/databases/infantfeeding/countries/en/index.html (and for the two studies from Scotland (Hoddinott 2009; Muirhead 2006), we used http://www.isdscotlandarchive.scot.nhs.uk/isd/1914.html, both accessed November 2011).

Hospital (Baby Friendly) and community settings

Twenty-two of the 52 studies were carried out both on hospital postnatal wards and in community settings (these include hospital and community clinics). Five of the 22 hospital-based studies were set in hospitals with Baby Friendly accreditation (Aksu 2011; Chapman 2004; Coutinho 2005; de Oliveira 2006; Sinclair 2007). Thirty studies were conducted in community settings only. In one of these (Kronborg 2007), the five hospitals serving the area from which the study participants were recruited had all adopted the standards of the Baby Friendly Hospital Initiative, and three of them were certified as Baby Friendly. In another (Hoddinott 2009) the clusters were seven intervention group localities paired with seven control group localities. In the intervention group, the number of localities in which the hospital where most women gave birth had the Baby Friendly award was three before the intervention and four after the intervention. In the control group, the corresponding numbers were four localities before and six after the intervention.

Interventions

Level of the intervention

In 45/52 studies, women received the intervention. In six studies (three cluster-randomised trials; Bhandari 2003; Ekstrom 2006; and Kramer 2001, and three individually-randomised trials; Labarere 2005; Santiago 2003; Sinclair 2007), the intervention was additional training in breastfeeding support for staff. One cluster-randomised trial (Hoddinott 2009) evaluated a policy for providing breastfeeding groups.

Breastfeeding support: proactive/indirect

In 41/45 of the studies where women received the intervention and five of the six studies of staff training, breastfeeding support was delivered directly to women. In five other studies (Graffy 2004; Hoddinott 2009; Labarere 2005; Morrell 2000; Winterburn 2003), breastfeeding support was not proactively offered; women were encouraged to access it, but breastfeeding support was not delivered directly to women as part of these interventions. One study (Kools 2005) evaluated a multi-faceted intervention of which breastfeeding support delivered directly to women was one component.

One-to-one/group support

In 48/52 studies there was individual, one-to-one contact between the breastfeeding supporter and the breastfeeding mother. One study (Hoddinott 2009), offered group support, one (Ekstrom 2006) offered both individual and group support, and in two studies this aspect of support was unclear (Kools 2005; Kramer 2001).

Breastfeeding support from professional/ lay supporters

In the previous edition of this review, the people providing breastfeeding support were categorised as 'professional', 'lay and professional' or 'lay'. Using those categories, the 52 studies in this update comprise 30 studies of professional support, nine of lay and professional support and 13 of lay support. In view of the growing body of work evaluating breastfeeding peer support, we have distinguished between this and other kinds of lay support, following the definition by Dennis 2002: “Peer support is provided by lay individuals who are not part of the client’s own embedded network, who possess experiential knowledge of the targeted behaviour (i.e. successful breastfeeding skills) and similar qualities (i.e. age, socioeconomic status, ethnicity, residency etc.,) in order to aid the client during a time of actual or potential stress (i.e. the initiation and continuation of breastfeeding”.

Professional

In 30/52 studies a variety of medical, nursing and allied professionals (for example, nutritionists, lactation consultants and researchers) provided the breastfeeding support (Albernaz 2003; Bunik 2007; Bashour 2008; Bonuck 2005; Brent 1995; de Oliveira 2006; Di Napoli 2004; Ekstrom 2006; Frank 1987; Froozani 1999; Gagnon 2002; Jones 1985; Kramer 2001; Kronborg 2007; Lynch 1986; McDonald 2010; McQueen 2011; Petrova 2009; Porteous 2000; Pugh 1998; Quinlivan 2003; Santiago 2003; Serafino-Cross 1992; Sinclair 2007; Sjolin 1979; Su 2007; Vitolo 2005; Wrenn 1997).

Professional and lay

Professionals provided breastfeeding support with other people in a further nine studies; para-professionals (Kools 2005; Morrell 2000), peer supporters (Bhandari 2003; Hopkinson 2009; Pugh 2002; Pugh 2007), and lay people (employees who had to be mothers in Barros 1994; someone chosen by the mother in Winterburn 2003; and a group of mothers in Hoddinott 2009).

Lay

Lay people provided breastfeeding support in 13 studies. In eight of these, the lay people were peer supporters (Chapman 2004; Dennis 2002; Di Meglio 2010; Haider 2000; Leite 2005; Morrow 1999; Muirhead 2006; Tylleskar 2011a; Tylleskar 2011b; Tylleskar 2011c). The other five studies (Aksu 2011; Coutinho 2005; Graffy 2004; Jenner 1988; Mongeon 1995) did not report that the lay supporters met the criteria (Dennis 2002) for us to classify them as peer supporters. 

Training in breastfeeding support

Overall, 36/52 studies report that the people providing breastfeeding support had additional training to provide breastfeeding support (21/30 professional, 3/9 professional and lay and 12/13 peer/lay). Sixteen of the 21 studies where professionals had additional training give details of the training. In eight studies, the training was specific to the study (Bashour 2008; de Oliveira 2006; Ekstrom 2006; Labarere 2005; McDonald 2010; Santiago 2003; Sinclair 2007; Vitolo 2005) and lasted, where reported, five to 16 hours. In five of the remaining eight studies professionals had WHO/Unicef training for 18 hours (Di Napoli 2004; Kramer 2001; Kronborg 2007) or 40 hours (Albernaz 2003; Froozani 1999) and in three studies the professionals were International Board Certified Lactation Consultants (IBCLC) (Brent 1995; Petrova 2009; Pugh 1998).

In one of the studies of support from professionals and paraprofessionals, the professionals were lactation consultants (Kools 2005) and in the other they were midwives not stated to have had extra training in breastfeeding support (Morrell 2000); in both these studies the para-professionals were trained to refer women with breastfeeding problems to the professionals. Two of the four studies of support from professionals and peers reported training; in Bhandari 2003 peer supporters received WHO-based training, and in Hopkinson 2009 the professionals were IBCLCs and the peer supporters had three days training in lactation management, 20 hours training in peer counselling and at least one year’s work experience. One of the three studies study of professional and lay support states lay supporters received breastfeeding support training (Barros 1994).

All eight studies of peer support (alone) reported peer supporters were trained. The training was WHO 20 hours (Leite 2005), 40 hours (Haider 2000) or one week (Tylleskar 2011); La Leche League (LLL) 30 hours (Chapman 2004), 20 hours (Di Meglio 2010) and length not specified (Morrow 1999). Two studies reported the length but not the type of training; 2.5 hours (Dennis 2002) and more than two days (Muirhead 2006). Three of the five studies of lay support (alone) reported breastfeeding training; WHO 18 hours plus five days (Coutinho 2005), WHO 18 hours (Aksu 2011) and National Childbirth Trust training (Graffy 2004).

Mode of support (face-to-face and/or by telephone)

Twenty-seven of the 52 studies offered telephone support and all but one of these (Albernaz 2003, Brazil) were undertaken in countries classified High Income by the World Bank. Three studies (Dennis 2002; Bunik 2007; Di Meglio 2010) offered breastfeeding support only by telephone. Twenty-four offered both face-to-face and telephone support, with telephone support either predominant (e.g. Muirhead 2006; Petrova 2009) or as backup (e.g. Chapman 2004). In some studies (e.g. Kools 2005; Pugh 1998), telephone contact with the breastfeeding support specialist came after the women had been visited by someone else. Across the 27 studies examining telephone support, details of whether or not the telephone support was proactively offered by the peer or professional supporter were not consistently reported. Twenty-four studies offered only face-to-face support. In the one remaining study (Winterburn 2003), the support was not proactive and the mode of support was not specified.

Support with an antenatal component and intention to breastfeed

The outcomes of interventions intended to promote longer duration of breastfeeding could be expected to differ according to whether women were recruited before or after they started to breastfeed. Two-thirds of the studies (34/52) included postnatal women at or after initiation of breastfeeding. In the one study of breastfeeding in groups (Hoddinott 2009), pregnant women and breastfeeding mothers could be invited to attend groups. The remaining 17 studies recruited women before the birth, not all of whom went on to initiate breastfeeding. Six of the 17 studies (Kramer 2001, Belarus; Jenner 1988 and Winterburn 2003, UK; Serafino-Cross 1992, US; Mongeon 1995, Canada; Tylleskar 2011a; Tylleskar 2011b; Tylleskar 2011c, Burkina Faso, Uganda and South Africa) included only women who intended to breastfeed. In the study by Tylleskar 2011, this inclusion criterion was related to HIV/AIDS prevention and management in the country and study populations. Eleven studies that recruited before the birth did not specify that participants had to intend to breastfeed.

Intensity of the intervention

Forty-five of the 52 studies reported the intensity of the intervention in terms of the number of postnatal contacts the mother could have for breastfeeding support. Sixteen studies specified three or fewer contacts, 16 four to eight contacts, and the remaining 13 studies specified nine or more contacts. We have performed a subgroup analysis and results are described in the text.

Duration of the intervention and duration of data collection

The length of time between the end of an intervention and collection of outcome data could be a factor in effectiveness of the intervention. Among the 52 studies, duration of the intervention ranged from three days to one year and the last data collection point for breastfeeding outcomes ranged from two weeks to 18 months (note the analyses in this review only include data where follow-up was at least 75%). For 46/52 studies it was possible to calculate the length of time between the end of the intervention and the end of data collection. In 21 studies the intervention and data collection ended at the same time (at one year in three studies; six months in seven studies; five months in one study; four months in four studies; three months in five studies and at four weeks in one study, Porteous 2000). In the remaining 25 studies the time interval between the end of the intervention and the end of data collection ranged from 1.5 weeks (Gagnon 2002) to 17.9 months (Aksu 2011); in these two studies the intervention ended at four and three days respectively.

Control group care

Five of the 52 studies were undertaken in hospital settings with Baby Friendly accreditation (Aksu 2011; Chapman 2004; Coutinho 2005; de Oliveira 2006; Sinclair 2007). These study interventions were additional to care that met Baby Friendly standards and were received by everyone at the hospital including all the study participants in the intervention and control groups. In two community-based cluster-randomised trials (Hoddinott 2009; Kronborg 2007), most of the maternity hospitals in which the participants had given birth had Baby Friendly accreditation. In 20 studies control group care was not specified (n = 7) or stated to be standard care but not described (n = 13). In half the studies (27/52) there was some description of control group care (see Characteristics of included studies). Standard postnatal care varies both between and within countries. Care may have differed within the study period and may also have differed from that which is offered at the present time.

Outcomes

Level of data collection

In 45/52 studies data outcome data were collected from the women who had received the intervention. In the other seven studies, the relationship between the recipients of the intervention and the source of the outcome data varied. In the three individually-randomised trials of staff training (Labarere 2005; Santiago 2003; Sinclair 2007), outcome data came from all the women randomised to receive, or not to receive, a support intervention from trained staff. In one of the three cluster-randomised trials of staff training (Ekstrom 2006), data came from mothers of singleton term healthy infants at centres where staff had been randomised, or not randomised, to receive training. In another (Bhandari 2003) trained staff visited all families in the intervention villages and outcome data were collected from all infants in the intervention and control villages, and in the third (Kramer 2001), staff in all intervention sites were trained and data were collected from mothers who intended to breastfeed in the intervention and control sites. In the cluster-randomised trial that evaluated a policy for providing breastfeeding groups (Hoddinott 2009), the policy intervention was made at locality level. Pregnant or postnatal women could be invited to groups in intervention clusters; however, only 1310 pregnant or breastfeeding women out of more than 9000 births in the intervention localities attended any group.

Duration of any and/or exclusive breastfeeding

The breastfeeding outcomes reported reflect World Bank country income group of the countries where the 52 studies were undertaken. Most studies (29/52) report the effect of the intervention on rates of both any and exclusive breastfeeding. However, all 14 studies that only report any breastfeeding were undertaken in high-income countries, and the nine studies that only report exclusive breastfeeding include all four from low-/lower-middle-income countries. Some studies newly included in this review report details about data collection that make it clear duration of exclusive breastfeeding at specific time points was not necessarily measured from birth (Tylleskar 2011a; Tylleskar 2011b; Tylleskar 2011c; Vitolo 2005); most studies do not report this level of detail.

Secondary outcomes

A few studies reported various infant morbidity and maternal satisfaction with feeding and care outcomes by intervention group, as follows: infant morbidity in 11 studies (Bashour 2008; Bhandari 2003; Bunik 2007; Frank 1987; Froozani 1999; Kramer 2001; Morrow 1999; Petrova 2009; Pugh 2002; Quinlivan 2003; Tylleskar 2011a; Tylleskar 2011b; Tylleskar 2011c); maternal satisfaction with feeding in 11 studies (Bashour 2008; de Oliveira 2006; Dennis 2002; Hoddinott 2009; Hopkinson 2009; Kronborg 2007; Labarere 2005; McDonald 2010; McQueen 2011; Petrova 2009; Pugh 1998) and maternal satisfaction with care in six studies (Bashour 2008; Ekstrom 2006; Graffy 2004; Jones 1985; Kools 2005; Morrow 1999).

 

Excluded studies

We excluded 79 studies from the review. The main reason for exclusion was because studies were not randomised trials, or it was not clear that allocation to groups had been carried out randomly; we excluded 18 studies identified by the search for this reason (Caulfield 1998; Davies-Adetugbo 1996; Ebbeling 2007; Garcia-Montrone 1996; Hall 2007; Jang 2008; Kistin 1994; McInnes 2000; Moreno-Manzanares 1997; Neyzi 1991; Nor 2009; Pascali-Bonaro 2004; Perez-Escamilla 1992; Segura-Millan 1994; Sisk 2006; Susin 2008; Thussanasupap 2006; Valdes 2000). A further two papers were reviews rather than reports of a randomised controlled trials (Guise 2003; Lewin 2005).

We excluded 38 trials because the intervention was not relevant to this review. We excluded 17 trials on the grounds that studies examined educational interventions where the focus was on instruction rather than on support to women to encourage breastfeeding (Bolam 1998; Cattaneo 2001; Forster 2004; Hauck 1994; Henderson 2001; Isselmann 2006; Jakobsen 2008; Jones 2004; Labarere 2003; Lavender 2004; Mattar 2003; Rea 1999; Rossiter 1994; Sakha 2008; Schy 1996; Wallace 2006; Westphal 1995). We excluded a further 13 trials as the intervention was not designed to support continued breastfeeding; these studies examined more general interventions in the postnatal period (Ball 2011; Barlow 2006; Barnet 2002; Black 2001; Gagnon 1997; MacArthur 2002; Peterson 2002; Pollard 2011; Ratner 1999; Rush 1991;Serrano 2010; Thomson 2009; Wiggins 2005); a further trial by Baqui 2008 focused on breastfeeding initiation only, rather than on postnatal support to encourage continuation. Seven of the studies examined interventions carried out in the antenatal period only, and had no postnatal support component (Forster 2006; Johnston 2001; MacArthur 2009; Olenick 2011; Noel-Weiss 2006; Reeve 2004; Wockel 2009).

Fifteen of the studies that we assessed for inclusion were excluded as they did not focus on healthy mothers with healthy term infants. Four trials examined interventions for low birthweight babies (Agrasada 2005; Brown 2008; Junior 2007; Pinelli 2001), while the study by Ahmed 2008 recruited only mothers of premature babies. In the trials by Davies-Adetugbo 1997 and Haider 1996, mothers of babies with severe diarrhoea were recruited, and the studies by Merewood 2006 and Phillips 2010 recruited only mothers of babies admitted to neonatal intensive care unit. The trial by Ferrara 2008 focused on an intervention for mothers with diabetes and that by Gijsbers 2006 on families with a history of asthma, while Moore 1985 looked at infants with a parent with eczema or asthma. Three other trials recruited only women in high-risk groups (Chapman 2011; McLeod 2003; Rasmussen 2011).

The remaining trials were excluded for other reasons (Finch 2002; Lieu 2000; Mannan 2008; Rowe 1990; Sciacca 1995; Steel O'Connor 2003). Further details of these, and other excluded studies, can be found in the Characteristics of excluded studies tables.

Risk of bias in included studies

Each trial was assessed for methodological quality as outlined in the Methods section.

Allocation

We considered that approximately half of the studies contributing data to the review used methods that were at low risk of bias to generate the randomisation sequence and to conceal allocation to experimental groups. We assessed that 30 of the 52 studies contributing data were at low risk of bias for sequence generation and 26 were at low risk of bias for methods to conceal group allocation. Methods were either not described or were not clear for 15 studies with regard to sequence generation, and for 19 for allocation concealment. We assessed that seven studies were at high risk of bias for both the methods used to generate the randomisation sequence and to conceal group allocation at the point of randomisation (de Oliveira 2006; Froozani 1999; Grossman 1990; Jenner 1988; Jones 1985; Sjolin 1979; Wrenn 1997). These studies used methods such as alternation, day of clinic attendance, or time of day of birth to generate the randomisation sequence; the use of such methods would mean that those carrying out randomisation would not be blind to group allocation.

Blinding

With interventions of this type, assessing risk of bias associated with blinding is very difficult. Both mothers and the staff providing care would be likely to be aware that they were either receiving or delivering an intervention. In studies where there was randomisation at the clinic level all women may have been exposed to the same intervention, and contamination between groups would thereby be reduced, but there may still have been a risk of response bias if outcomes were reported to staff providing care.

In 19 of the 52 studies contributing data there was an attempt made to blind those staff assessing outcomes. However, it was not clear whether these attempts at blinding were successful. While interviewers collecting outcome data were frequently described as "blind" to group status, mothers may well have revealed whether or not they had received an intervention. For outcomes such as reported breastfeeding, lack of blinding, or unsuccessful blinding of outcome assessors, may represent a serious source of bias.

Incomplete outcome data

We had prespecified that we would not include data for any outcome where there were missing data for more than 25% of the randomised group. Loss to follow-up was a particular problem in studies where women were recruited in the antenatal period and, as we have described above, we have not included any outcome data from 10 studies that were otherwise eligible for inclusion in the review because of high levels of attrition for all outcomes.

For some of those studies contributing data there was still considerable loss to follow-up, and loss was not always balanced across randomisation groups. In the study by Albernaz 2003, almost a quarter of the sample was lost to follow-up, and more than 20% were lost in the Di Meglio 2010 and Vitolo 2005 trials. In three studies, we were only able to use limited outcome data as at later data collection points attrition exceeded 25% of the randomised sample (Hoddinott 2009; Petrova 2009; Serafino-Cross 1992), and in the study by Wrenn 1997, loss was not balanced across treatment groups; even moderate attrition may be a serious source of bias if loss is not balanced both in terms of the amount of loss and the reasons for loss to follow-up.

Selective reporting

We assessed bias in most of the studies included in the review from published study reports. In most cases we did not have access to the trial registration or protocol. Under these circumstances assessing risk of bias due to selective reporting bias is very difficult. For this reason, we assessed all of the studies as being of unclear risk of bias for this domain.

Other potential sources of bias

We have noted any other concerns about bias (including any apparent baseline imbalance between randomised groups) in the Characteristics of included studies tables along with further information about the judgements we made about risk of bias for each included study. The quality of the studies was very mixed and most of the studies had some methodological weakness, or did not provide good information about methods. It is important that the mixed quality of the evidence is taken into account in the interpretation of results.

Effects of interventions

Interventions to support breastfeeding versus usual care: 52 studies

The focus of this review is on breastfeeding support rather than on interventions to promote breastfeeding initiation which is addressed in another related Cochrane review (Dyson 2005). In this review we wanted to examine whether support would reduce the number of women who stopped breastfeeding early. For those studies with an antenatal component we cannot be certain that all women randomised actually started breastfeeding and received a postnatal support intervention. We carried out analysis on an intention to treat basis and all women are accounted for in the analysis whether or not they started breastfeeding and whether or not they received the intended support intervention. For primary outcomes the denominators are the number of women randomised and the women who are described as having “stopped” breastfeeding may include some women who may not have initiated or established breastfeeding.

The main outcome measures in the review are the effects of the interventions on duration of any, or exclusive breastfeeding up to specified points in time. Some studies reported exclusive breastfeeding rates and provided a clear definition of what this meant, but others were ambiguous and it was difficult for us to ascertain whether the infant was fed breast milk alone. For outcomes relating to any breastfeeding it was not always clear in study reports whether this meant that babies were predominantly or only occasionally receiving breast milk, and readers should be aware that definitions varied in different trials, and at different time points in the same trial as weaning foods were gradually introduced.

For cluster-randomised trials, where sufficient information was provided, we adjusted the sample sizes and event rates to take account of the design effect. Therefore, where we have provided information about the number of women in each analysis this represents the effective (adjusted) sample size (Donner 2000). In the analyses the cluster-randomised trial by Tylleskar et al carried out in three African countries has been entered and reported as three separate studies with adjustment of the sample size for each outcome using different reported ICCs for each country (Tylleskar 2011a (Burkina Faso); Tylleskar 2011b (Uganda); Tylleskar 2011c (South Africa)).

Primary outcomes

The main summary outcome measure was cessation of any breastfeeding at the time of the last study assessment up to six months. In the meta-analysis for this outcome we have included 40 trials with 14227 women (effective sample size). On average, interventions to support breastfeeding appear to have a beneficial effect on the number of women continuing breastfeeding beyond six months, with fewer women in the groups receiving support stopping breastfeeding by this time (average risk ratio (RR) 0.91, 95% confidence interval (CI) 0.88 to 0.96; 95% prediction interval 0.74 to 1.12) (Analysis 1.1). Overall, 50.9% of those receiving support interventions had stopped any breastfeeding by six months compared with 55.5% of controls (unweighted percentages). However, there was moderate heterogeneity for this outcome, and although the average treatment effect was positive, the wide prediction interval indicates that the effect may not be beneficial in all settings. Results should therefore be interpreted with caution (heterogeneity: tau² = 0.01, I² = 56%, Chi² test for heterogeneity P < 0.0001)). Visual inspection of the funnel plot generated for this outcome suggested that there was some asymmetry with results from smaller studies tending to show a greater positive treatment effect (Figure 3). The Harbord 2006 test for small-study effects was significant (P = 0.009) (data not shown). Sensitivity analysis using only studies assessed as low risk of bias for allocation concealment demonstrated a similar positive treatment effect on breastfeeding at up to six months (Analysis 1.8).

Figure 3.

Funnel plot of comparison: 1 All forms of support versus usual care, outcome: 1.1 Stopping breastfeeding (any) before last study assessment up to 6 months.

Thirty-three studies with 11961 women reported the number of women who had stopped exclusive breastfeeding at up to six months. Women in the intervention groups were less likely to have stopped exclusive breastfeeding before six months (average RR 0.86, 95% CI 0.82 to 0.91); while 73.9% of women in the intervention groups had stopped exclusive breastfeeding by this time, this applied to 83.1% of women in control groups (unweighted percentages) (Analysis 1.2). There was considerable variation in the size of the treatment effect amongst these studies and the wide prediction interval suggests that in some studies support may not be beneficial (heterogeneity: Tau² = 0.02, I² = 97%, Chi² test for heterogeneity P < 0.00001; 95% prediction interval 0.64 to 1.15). Sensitivity analysis using only studies assessed as low risk of bias for allocation concealment revealed that results still significantly favoured the intervention groups, although the effect size was considerably reduced in the studies at low risk of bias (RR 0.94, 05% CI 0.90 to 0.98; 95% prediction interval 0.76 to 1.17) compared with those at unclear or high risk of bias (RR 0.63, 95% 0.45 to 0.89) which suggests that the treatment effect may be partly due to bias (Analysis 1.9). Visual examination of a funnel plot for this outcome suggested that the treatment effect may have been more pronounced in smaller studies and Harbord's test for asymmetry was significant (P = 0.003) (Figure 4).

Figure 4.

Funnel plot of comparison: 1 All forms of support versus usual care, outcome: 1.2 Stopping exclusive breastfeeding before last study assessment.

Stopping breastfeeding before four to six weeks was reported in 25 studies with 8513 women. Women receiving support interventions were less likely to stop breastfeeding before six weeks (average RR 0.88, 95% CI 0.81 to 0.96) although there was considerable variation in the results from individual studies (heterogeneity: Tau² = 0.02, I² = 50%, Chi² test for heterogeneity P = 0.002; 95% prediction interval 0.65 to 1.19) (Analysis 1.3) (Figure 5). Women in the intervention groups were also less likely to abandon exclusive breastfeeding by six weeks compared with women in the control groups, although results should be interpreted with caution as the size of the treatment effect varied considerably in different studies and the wide prediction interval for this outcome suggests that in some settings the intervention may not be beneficial (average RR 0.74, 95% CI 0.61 to 0.89; 24 studies, 7693 women), (heterogeneity: Tau² = 0.20, I² = 98%, Chi² test for heterogeneity P < 0.00001; prediction interval 0.29 to 1.91) (Analysis 1.4), Again, there was some evidence that the treatment effect may be partly due to bias; sensitivity analysis including only those studies assessed as being at low risk of bias for allocation concealment showed that results still favoured the intervention group although the treatment effect was less pronounced in the studies at lower risk of bias and for any breastfeeding the result was borderline for statistical significance (Analysis 1.10; Analysis 1.11). Visual examination of the funnel plot for this outcome suggested that the treatment effect may have been more pronounced in smaller studies and the test for asymmetry was significant (Figure 6).

Figure 5.

Funnel plot of comparison: 1 All forms of support versus usual care, outcome: 1.3 Stopping breastfeeding (any) at up to 4-6 weeks.

Figure 6.

Funnel plot of comparison: 1 All forms of support versus usual care, outcome: 1.4 Stopping exclusive breastfeeding at up to 4-6 weeks.

Secondary outcomes

Analysis of results at different periods of follow-up presented us with some challenges in interpreting the data. There was variability between the studies regarding the time points when data were collected, therefore, caution has to be exercised when interpreting the trends. However, analysis of results at different periods of follow-up suggest that the benefit of all forms of support was present at all time points up to nine months (Analysis 1.5).

Health outcomes for mothers and babies

Few trials reported health outcomes and due to variation in outcomes reported, and the time at which different outcomes were measured, it was not possible to combine results in meta-analysis.

Few trials reported mothers’ satisfaction or babies’ health outcomes and due to variation in the outcomes reported, times at which different outcomes were measured and missing data, it was not possible to combine results in meta-analyses.

Health outcomes for babies

Neonatal or infant morbidity outcomes were reported by study group in 11 studies. The PROBIT study (Kramer 2001) found a significant reduction in the risk of one or more gastrointestinal infections and of atopic eczema in the clusters receiving care from health professionals who had received the WHO/UNICEF Baby Friendly Initiative training. No significant reduction in respiratory tract infection was found. The PROBIT team have published several follow-up studies reporting child health outcomes (see Kramer 2001 References to included studies). Froozani 1999 observed a significant reduction in the mean number of days of gastrointestinal illness in the group receiving support but no significant difference in respiratory illness. The number of babies reported to have suffered diarrhoea within the last fortnight at three months was reduced in the intervention groups in all three study areas in the large cluster trial in three African countries, and at six months fewer babies in the intervention group were reported to have had diarrhoea in Burkina Faso and Uganda, although not in South Africa (Tylleskar 2011a; Tylleskar 2011b; Tylleskar 2011c). Bhandari 2003 found prevalence of diarrhoea at seven days was lower in the intervention than in the control communities at three months (odds ratio (OR) 0.64, 95% CI 0.44 to 0.95) and six months (OR 0.85, 95% CI 0.72 to 0.99). Morrow 1999 reported that at three months postpartum, fewer intervention (12/96) than control (9/34) infants had had an episode of diarrhoea (P = 0.029).

Bunik 2007 reported that 40/161 babies in the intervention required health care in the first month of life while this applied to 65/180 in the control group. Pugh 2002 (n = 41) reported that infants in the intervention group had fewer visits to the healthcare provider for both checkups and sick visits and significantly fewer prescriptions (P < 0.05) than control group infants. Frank 1987 and Petrova 2009 found no difference in re-hospitalisation rates between infants in the intervention and control groups. In the study by Bashour 2008 a broad range of outcomes relating to infant morbidity was reported, however, results were difficult to interpret as the intervention also included advice relating to immunisations and baby care. Quinlivan 2003 reported a reduction in adverse neonatal outcomes (infant death, severe non-accidental injury and non-voluntary foster care) in the intervention group (2/65) compared with the control group (9/71) (RR 0.24, 95% CI 0.32 to 1.52).

Maternal satisfaction with care

Maternal satisfaction with care was reported by study group in six studies. Jones 1985 found that mothers in the intervention group were more satisfied with the help they received than were mothers in the control group. When interviewed at the end of the study by Morrow 1999, 66% of mothers in the intervention group said the most important source of infant feeding advice was a peer counsellor, followed by a physician (19%) and their mothers (7%); in the control group, 50% listed a physician as their most important source, followed by their mother (22%) and a peer counsellor (2%). Graffy 2004 found that more women in the intervention group than in the control group said their most helpful advice came from counsellors rather than from other sources. In Kools 2005, opinions of mothers about feeding advice from caregivers were no more positive in the intervention group than in the control group, except for slightly less contradictory feeding advice (P = 0.04). Ekstrom 2006 found mothers in intervention clusters were more satisfied with emotional and informative support during the first nine months postpartum than mothers in control clusters. Bashour 2008 reported over 80% of the women in each group were happy about their experiences during the postnatal period, with no significant differences between the groups.

Maternal satisfaction with feeding

Maternal satisfaction with feeding was reported in 11 studies. Dennis 2002 found that significantly more mothers in the peer support group than in the control group were satisfied with their infant feeding experience. In the study by Petrova 2009 over 90% of women in both groups reported they were satisfied with their breastfeeding experience, with no statistically significant differences between the groups. Hoddinott 2009 found no significant differences in maternal satisfaction with breastfeeding between intervention and control localities.

de Oliveira 2006 reported a range of breastfeeding problems at seven and 30 days and overall, the intervention group appeared to have fewer problems with nipple pain and breast engorgement at both time points. In the study by Hopkinson 2009 outcomes relating to breastfeeding problems were reported including low milk supply, breast engorgement, difficulty breastfeeding, breast pain and exhaustion. Results were not consistent however; women in the intervention group had more positive outcomes for some problems (e.g. engorgement and breast pain). Labarere 2005 reported that similar numbers of women in the intervention and control groups reported breast pain and mastitis although fewer women in the intervention group (26/112) reported having "not enough milk" compared with women in control groups (43/114). Bashour 2008 reported the number of women complaining of breast engorgement; there were no clear differences between groups. Pugh 1998 found no differences between groups in mean maternal fatigue scores at six months. McDonald 2010 found no statistically significant differences between the groups in breastfeeding problems, though the problems experienced changed over time; engorgement, unsettled baby, nipple soreness and attachment difficulty were reported more frequently at two months, and low milk supply and unsettled baby at six months.

McQueen 2011 found no significant difference between intervention and control group mothers in breastfeeding self-efficacy scores. Kronborg 2007 found mothers in the intervention group reported more confidence than those in the control group about not knowing the exact amount of milk their babies had received when being breast fed.

Subgroup analysis

There was considerable variation between the trials in terms of the interventions examined, the standard care offered to women, and the background breastfeeding initiation rates in the various study settings. We wanted to explore whether different types of support and settings were associated with different or more pronounced treatment effects. Therefore, for the review's four primary outcomes we carried out subgroup analysis to explore the impact of interventions involving different types of supporter (professional versus lay person, or both); types of support (face-to-face versus telephone support or both); timing of support (antenatal and postnatal versus postnatal alone); whether the support was proactive (scheduled contacts) or reactive (women needed to request support); and whether support interventions had similar effects in settings with different background breastfeeding initiation rates (low, medium or high background rates).

Who delivered the support

For our four primary outcomes, we examined whether the treatment effect was similar where the support was delivered by professionals as opposed to non-professionals (lay support) or both. For cessation of any breastfeeding at up to six months it appeared that support from non-professionals was associated with an increased treatment effect (RR 0.85, 95% CI 0.77 to 0.93), compared with support from professionals or both (RR 0.94, 95% CI 0.88 to 0.99 and RR 0.97, 95% CI 0.91 to 1.03 respectively), (Analysis 2.1), although the test for subgroup differences was borderline for statistical significance (P = 0.05, I² = 66.4). For cessation of any breastfeeding by four to six weeks) there were no clear differences between subgroups; for this outcome there was considerable within subgroup heterogeneity and there were no significant differences between subgroups (Analysis 2.3). For cessation of exclusive breastfeeding at up to six months the treatment effect appeared to be greater where the intervention was delivered by non-professionals (lay support) (average RR 0.74, 95% CI 0.64 to 0.87) compared with professionals (average RR 0.93, 95% CI 0.88 to 0.98) or both (average RR 0.76, 95% CI 0.44 to 1.32 (Analysis 2.2). The test for subgroup differences for this outcome was statistically significant (Chi² = 7.67, df 2, P = 0.02, I² = 73.9%). This difference was consistent with cessation of exclusive breastfeeding at four to six weeks; again, the effect size was more pronounced with lay support than with professional support, (Analysis 2.4). The test for subgroup differences was significant (Chi² = 6.44, df 2, P = 0.04, I² = 68.9%). However, in view of considerable within-subgroup heterogeneity, these findings should be interpreted with caution. Further, as we discussed above, there was some evidence that more pronounced treatment effects were associated with studies at higher risk of bias; this could potentially confound any differences between subgroups.

Type of support

We compared different types of intervention (support provided predominantly by face-to-face contact, predominantly by telephone, or by both face-to-face and telephone contact) for our primary outcomes. For cessation of exclusive breastfeeding there was some evidence that face-to-face support was associated with a greater positive treatment effect compared with either telephone support or mixed telephone and face-to-face support. For cessation of exclusive breastfeeding at up to six months women who received support face-to-face were almost 20% less likely to have given up exclusive breastfeeding by the last study assessment up to six months compared with those in the control groups (average RR 0.81, 95% CI 0.75 to 0.88), (Analysis 3.2). There was no significant treatment effect for support that was predominantly by telephone, or that involved both face-to-face and telephone contact (average RR respectively: 1.00, 95% CI 0.99 to 1.01; average RR 0.98, 0.94 to 1.02) (Analysis 3.2). The test for subgroup differences suggested that the difference between subgroups was statistically significant (Chi² = 27.52, df 2, P = 0.00001, I² = 92.7%).

This difference between subgroups persisted for cessation of exclusive breastfeeding at up to four to six weeks. Again, while there was no significant difference between control and intervention groups for predominantly phone and mixed support (RR 0.96, 95% CI 0.68 to 1.35; RR 0.94, 95% CI 0.88 to 1.01), (Analysis 3.4), there was a positive treatment effect for those women receiving face-to-face support although there was considerable heterogeneity within this subgroup (average RR 0.62, 95% CI 0.51 to 0.77). The test for between subgroup differences was significant (Chi²= 13.73, df = 2, P < 0.001, I² = 85.4%).

These differences between subgroups did not apply to cessation of any breastfeeding at last study assessment or at up to four to six weeks; for these outcomes there was high heterogeneity within subgroups, and the tests for subgroup differences were not significant (Analysis 3.1; Analysis 3.3).

When the support was offered

We examined whether offering support with an antenatal component rather than postnatal support alone was associated with any difference in treatment effect. The results were similar in both subgroups for all of our four primary outcomes and there were no statistically significant subgroup differences, (Analysis 4.1; Analysis 4.2; Analysis 4.3; Analysis 4.4).

Proactive versus reactive support

We had planned to carry out formal subgroup analysis by whether support was proactive or reactive but due to the fact that most interventions included at least one scheduled contact (proactive), we did not think that this way of categorising studies would shed light on types of interventions that were effective or ineffective. However, in five studies the way in which support was offered differed substantively from other studies in that women were expected to access the support and it was not delivered directly to them (Graffy 2004; Hoddinott 2009; Labarere 2005; Morrell 2000; Winterburn 2003). None of these studies found a difference in outcomes between control and intervention groups. We will return to this issue in the discussion.

Background breastfeeding initiation rates in study settings

We were interested in whether or not background rates of breastfeeding in different settings had any impact on the success of interventions. We divided the studies into three groups: those carried out in settings where 80% or more women initiated breastfeeding (high background initiation), where between 60% to 80% initiated breastfeeding (intermediate) or where breastfeeding initiation rates were less than 60% (low). These groups showed an inverse relationship with World Bank country income groups. The studies with high background rates of breastfeeding initiation were set in countries from all the World Bank country income groups, however, the four studies from low-/low-middle-income countries had the highest rates (more than 95%). All the studies with intermediate or low background rates of breastfeeding initiation were undertaken in high-income countries.

While there was no clear differences between subgroups for cessation of any breastfeeding at up to six months (Analysis 5.1), it appeared that for cessation of exclusive breastfeeding there were some differences between subgroups. Interventions were associated with a more pronounced effect on exclusive breastfeeding at up to six months in settings where there were high background rates of breastfeeding initiation (average RR 0.83, 95% CI 0.78 to 0.89) compared with areas where there was intermediate or low background initiation rates (average RR respectively 0.89, 95% CI 0.79 to 1.01; and RR 1.00, 95% CI 0.99 to 1.01), (Analysis 5.2). The test for subgroup differences was statistically significant despite considerable within group heterogeneity (Chi² = 27.5, df = 2, P < 0.0001, I² = 92.7%). Results were even more pronounced for cessation of exclusive breastfeeding at up to four to six weeks with interventions seeming to be most effective for women living in areas with high background initiation rates (average RR 0.61, 95% CI 0.47 to 0.80) compared with areas with intermediate or low rates (average RR respectively 0.81, 95% CI 0.68 to 0.96; and RR 0.97, 95% CI 0.86 to 1.08), (Analysis 5.4), (test for subgroup differences: Chi² = 10.26, df = 2, P < 0.006, I² = 80.5%). The same pattern persisted for cessation of any breastfeeding at up to four to six weeks with areas where background breastfeeding rates were high having a more pronounced treatment effect, although the test for subgroup differences did not reach statistical significance (Analysis 5.3).

Intensity of the intervention: the number of postnatal contacts

We examined whether different numbers of postnatal contacts were associated with any difference in treatment effect. We divided the studies into four subgroups: unspecified or no direct contacts (for example in studies that involved staff training rather than direct contacts with women); less than four postnatal contacts; between four and eight contacts; and more than eight contacts. For any breastfeeding there were no clear subgroup differences, (Analysis 6.1; Analysis 6.3). For exclusive breastfeeding at the final study assessment there was evidence of subgroup differences, although there was no clear "dose-response" effect; the most pronounced treatment effect was associated with between four and eight postnatal contacts (average RR 0.71, 95% CI 0.60 to 0.84) (test for subgroup differences P = 0.02, I² = 71%), (Analysis 6.2). However, as we discussed above, there was some evidence that more pronounced treatment effects were associated with studies at higher risk of bias; this could potentially confound any differences between subgroups. For exclusive breastfeeding at up to four to six weeks the test for subgroup differences did not reach statistical significance, although again women receiving between four and eight postnatal contacts were the most likely to be still exclusively breastfeeding at this time-point, (Analysis 6.4).

Discussion

Summary of main results

This substantively updated review provides evidence that breastfeeding support interventions increase the number of women continuing to breastfeed, and the number of women continuing to exclusively breastfeed, at up to six months and at up to four to six weeks. The size of the treatment effects varied considerably in different trials, and average treatment effects may not be applicable in different settings. The subgroup analysis suggested that face-to-face support was associated with a greater treatment effect than telephone support for exclusive breastfeeding, and that interventions had an increased effect on exclusive breastfeeding in areas where background breastfeeding initiation was high.

The 52 trials included span the years from 1979 to 2011, with 37 (71%) having been published since 2000. They were conducted in 21 countries, with 37 (55% of participants) being conducted in high-income countries, two in low-income countries (one in Bangladesh, one in Burkino Faso, Uganda and South Africa) and the remainder in low-to-middle income countries.  These numbers indicate that the challenge of supporting women to breastfeed is both longstanding and international; this is also reflected in the continuing low rates of duration and exclusivity of breastfeeding in many countries, despite increasing availability of good quality evidence of the scale of its public health impact.   

A striking aspect of this updated review is the heterogeneity of the support interventions, and the diversity of setting and of standard care. Interventions deemed by researchers to be ‘supportive’ included some where it was difficult to see how women might actually feel supported, especially when the support service provided was one they had to ask for, or travel a distance to get to (e.g. Graffy 2004; Hoddinott 2009), or where there was only one scheduled contact with the support person. Having said that, this updated review has shown that the effect of supportive interventions is robust across settings and population groups, and results from a wide range of interventions. 

Overall completeness and applicability of evidence

This review adds 18 trials to its predecessors (Britton 2007; Sikorski 2002), and the number of mother-infant pairs in these studies has increased to 56,451 from 29,385 in Britton 2007. The reporting of the included studies was, however, often not comprehensive - lacking, for example, in terms of a description of the components of the support intervention, details of the training and qualifications of the supporters, the definitions used of the extent of breastfeeding and in the description of adherence to the support protocol. There was also a failure to present details of the interventions and of the standard care available to both intervention and comparison groups. Very few of the trials described a theoretical basis for the intervention tested, with the result that the findings are difficult to explain or to replicate. There has been no notable improvement in study reporting or quality, with 26 out of the 52 trials contributing data (50%) reporting an approach to allocation concealment considered at low risk of bias compared to 15 of the 34 trials (44%) in the previous review.

Interventions offered were very diverse, as was the provision of standard care. Interventions included, for example, one individual session in hospital, offering women the opportunity to attend a group session in community settings, telephone support, and multiple one-to-one visits at home over several months. Five studies offered the intervention in the context of Baby Friendly accreditation of the hospital, and are unlikely to be generalisable to settings where this standard of care is not available to all women.

Study end-points also varied widely, with some substantial gaps of many months between the completion of the intervention and the last study outcome assessed. Very few interventions continue for longer than six months, and many only offered support in the early days or weeks. These factors, together with the range of different settings and population subgroups studied, should urge some caution in the interpretation of the analysis of pooled data.

Despite this caution, the overall benefit found from all forms of support interventions has been explored with subgroup and sensitivity analyses and is moderately robust following exclusion of the methodologically weaker trials. In this review, the greatest effect of breastfeeding support interventions on reducing cessation of breastfeeding before six months occurred in communities with high (over 80%) levels of breastfeeding initiation. This  suggests that work to promote breastfeeding at a population level should continue as one strategy to increase breastfeeding duration and exclusivity (Dyson 2009). 

While the effect size of support interventions on reducing the cessation of any breastfeeding is modest, there is evidence of a greater effect on the prolongation of exclusive breastfeeding. There was a reduction in the cessation of exclusive breastfeeding within the first six months and at up to four to six weeks when lay support was used, although the test for statistical significance was borderline at the earlier time point. Professional support, lay support and combinations of lay and professional support did not differ significantly in their effect on the continuance of any breastfeeding at either time-point, although the results were consistent with those for exclusive breastfeeding.

Few conclusions can be drawn about the impact on the health and wellbeing of mothers and babies in these studies, as very few studies measured such outcomes. Those that did identified a positive impact. This represents a missed opportunity to measure such key outcomes within a randomised trial context. 

We have explored a range of possible reasons to explain the significant heterogeneity in the findings.  As noted above, included studies were very varied in setting, population group studied, content, timing and intensity of the intervention, whether it was proactively offered to women or available only if they asked for it, the standard care available, staff training programmes, and the type and timing of the outcomes measured. Strategies that depend mainly on face-to-face support appear more effective than those that rely primarily on telephone contact. The duration of the intervention also seems to be an important factor. Interventions that relied on one session in hospital are very different from interventions where women receive repeated home visits. We attempted to examine this by assessing the intensity of the intervention, and found that studies with four to eight visits seemed to be associated with a more pronounced treatment effect. Care is needed in the interpretation of this finding as there is inconsistent reporting due to variations in the timing of outcome assessments, and the settings of studies and the population groups included in studies with more face-to-face visits also varied. It is likely that support will be most effective when it reflects the local needs of the population. It was notable that none of the five studies where women were expected to access support without any proactive element found a difference in outcomes between control and intervention groups. Four of these five were UK-based studies, which may help to explain the lack of effect seen in recent UK trials (Hoddinott 2011). 

Quality of the evidence

We considered that the overall methodological quality of trials included in the review was mixed, with approximately half of the included studies using methods that we assessed as being at low risk of bias for generating the randomisation sequence and concealing group allocation. When we carried out sensitivity analysis including only those studies at low risk of bias for allocation concealment, the results were not substantially different. A potentially important source of bias in these studies was the general lack of blinding. For support interventions trialists would face considerable difficulties in blinding staff, women and outcome assessors to treatment group. Even where there was an attempt made to blind outcome assessment there would still be a high risk of response bias for outcomes relying on self-report such as any or exclusive breastfeeding. A further possible source of bias was loss to follow-up and missing outcome data. Although we did not include outcome data where there was attrition of more than 25%, we are aware that even lower levels of attrition are problematic, particularly where loss was not balanced in different arms of trials. To avoid problems associated with attrition, we carried out intention-to-treat analysis for our primary outcomes; that is, we assumed that all women who were lost to follow-up had stopped breastfeeding by given time points. This is likely to have diluted overall treatment effects but these estimates may be more appropriate given the possibility of response bias and the increased likelihood of women who stopped breastfeeding dropping out before those who continued.

Potential biases in the review process

We are aware that there was a risk of introducing bias at all stages in the review process. In this updated version of the review two authors independently assessed eligibility for inclusion and carried out data extraction, and data checks were carried out by a third author. However, assessing risk of bias is not an exact science and involves judgement. We would encourage readers to consider the tables where the characteristics of included studies are summarised, to assist them in interpreting results.

Agreements and disagreements with other studies or reviews

These findings are similar to previous versions of this review, and the findings of other reviews (e.g. Dyson 2009; Guise 2003; Renfrew 1995), in that peer and professional support have been shown to be effective interventions.  We concur with others (e.g. Hoddinott 2011; Renfrew 2007) that it is critically important to identify the characteristics of support that may make this important but heterogenous intervention more or less effective in different circumstances. 

Authors' conclusions

Implications for practice

All women should be offered support to breastfeed their babies to increase the duration and exclusivity of breastfeeding. Healthcare settings should provide such trained support as standard. Support is likely to be more effective in settings with high initiation rates, so efforts to increase the uptake of breastfeeding should be in place. Support may be offered either by professional or lay/peer supporters, or a combination of both. Strategies that rely mainly on face-to-face support are more likely to succeed. Support that is only offered when women seek help is unlikely to be effective; women should be offered ongoing visits on a scheduled basis so they can predict that support will be available. Support should be tailored to the setting and the needs of the population group.

Implications for research

There are several areas which require further study in the light of the results of this review.

  • Future trials should describe in detail the attributes of the intervention (who delivered it, setting, intensity, proactive or reactive); standard care (Baby Friendly accreditation or not, staff trained in breastfeeding or not); the population group studied (low- versus high-income, any selection criteria); and the background breastfeeding rates in the population studies.

  • Trials should examine the potential for synergy between support and other interventions that aim to increase breastefeeding rates, as it may be that a package of interventions is more effective than single interventions in tackling the multifaceted challenge of increasing breastfeeding rates. Packages to be tested could include peer and professional support along with e.g. antenatal education, staff training, and mother-to-mother support.

  • Further trials are required to assess the effectiveness of lay, professional and combined support in different settings - in particular in those communities with low rates of breastfeeding initiation.

  • Trials should test the effectiveness of different training programmes (which should be well-defined and reproducible) and should attempt to address impact on both exclusive and any breastfeeding where possible.

  • Trials should explicate the theoretical basis for their approach, and analyse the elements of their approach that appear to have an impact, including training, timing, and intensity of the intervention, and differential impact on different population subgroups.

  • Prospective economic analyses are required to accompany trials to establish the cost-effectiveness of different interventions.

  • Implementation of the Baby Friendly Initiative should be accompanied by the continued monitoring of breastfeeding rates to explore whether its effect is similar in countries with differing rates of initiation and prevalence of breastfeeding.

  • Further trials to investigate appropriate strategies for supporting women who wish to breastfeed longer than six months are required.

  • Further exploration of maternal satisfaction and wellbeing should be included in future trials as these elements are consistently poorly evaluated.

  • Health outcomes for infants and mothers should be included in future trials, to examine this perspective on impact, and to allow assessment of such outcomes within randomised controlled trials. Trials should be appropriately sized if health outcomes are included.

 

Acknowledgements

The review authors wish to thank those study authors who were very helpful in responding to queries.

As part of the pre-publication editorial process, this review has been commented on by three peers (an editor and two referees who are external to the editorial team), a member of the Pregnancy and Childbirth Group's international panel of consumers and the Group's Statistical Adviser.

Work on this review was supported in part by a grant from the National Institute for Health Research Health Technology Assessment programme, grant number 10/106/01.

Data and analyses

Download statistical data

Comparison 1. All forms of support versus usual care
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Stopping breastfeeding (any) before last study assessment up to 6 months4014227Risk Ratio (M-H, Random, 95% CI)0.91 [0.88, 0.96]
2 Stopping exclusive breastfeeding before last study assessment3311961Risk Ratio (M-H, Random, 95% CI)0.86 [0.82, 0.91]
3 Stopping breastfeeding (any) at up to 4-6 weeks258513Risk Ratio (M-H, Random, 95% CI)0.88 [0.81, 0.96]
4 Stopping exclusive breastfeeding at up to 4-6 weeks247693Risk Ratio (M-H, Random, 95% CI)0.74 [0.61, 0.89]
5 Stopping any breastfeeding at different times43 Risk Ratio (M-H, Random, 95% CI)Subtotals only
5.1 Before 4 to 6 weeks258513Risk Ratio (M-H, Random, 95% CI)0.88 [0.81, 0.96]
5.2 Before 2 months82520Risk Ratio (M-H, Random, 95% CI)0.84 [0.71, 0.99]
5.3 Before 3 months206859Risk Ratio (M-H, Random, 95% CI)0.83 [0.75, 0.92]
5.4 Before 4 months93780Risk Ratio (M-H, Random, 95% CI)0.86 [0.77, 0.96]
5.5 Before 6 months155346Risk Ratio (M-H, Random, 95% CI)0.88 [0.79, 0.98]
5.6 Before 9 months2688Risk Ratio (M-H, Random, 95% CI)0.90 [0.81, 0.99]
5.7 Before 12 months32012Risk Ratio (M-H, Random, 95% CI)0.94 [0.84, 1.07]
6 Stopping exclusive breastfeeding at different times34 Risk Ratio (M-H, Random, 95% CI)Subtotals only
6.1 Before 4 to 6 weeks247693Risk Ratio (M-H, Random, 95% CI)0.74 [0.61, 0.89]
6.2 Before 2 months71524Risk Ratio (M-H, Random, 95% CI)0.64 [0.46, 0.89]
6.3 Before 3 months122896Risk Ratio (M-H, Random, 95% CI)0.66 [0.52, 0.82]
6.4 Before 4 months93400Risk Ratio (M-H, Random, 95% CI)0.69 [0.54, 0.88]
6.5 Before 5 months1590Risk Ratio (M-H, Random, 95% CI)0.47 [0.40, 0.54]
6.6 Before 6 months83149Risk Ratio (M-H, Random, 95% CI)0.89 [0.82, 0.97]
7 Duration of breastfeeding (mean number of days)160Mean Difference (IV, Fixed, 95% CI)48.00 [-10.98, 106.98]
8 Sensitivity analysis by risk of bias: stopping any breastfeeding at up to six months4014227Risk Ratio (M-H, Random, 95% CI)0.91 [0.88, 0.96]
8.1 studies at low risk of bias228795Risk Ratio (M-H, Random, 95% CI)0.93 [0.88, 0.98]
8.2 Risk of bias unclear or high185432Risk Ratio (M-H, Random, 95% CI)0.89 [0.83, 0.96]
9 Sensitivity analysis by risk of bias: stopping exclusive breastfeeding at up to six months3311961Risk Ratio (M-H, Random, 95% CI)0.86 [0.82, 0.91]
9.1 Studies at low risk of bias197681Risk Ratio (M-H, Random, 95% CI)0.94 [0.90, 0.98]
9.2 Unclear or high risk of bias144280Risk Ratio (M-H, Random, 95% CI)0.63 [0.45, 0.89]
10 Sensitivity analysis by risk of bias: stopping any breastfeeding at 4-6 weeks258513Risk Ratio (M-H, Random, 95% CI)0.88 [0.81, 0.96]
10.1 Studies at low risk of bias134985Risk Ratio (M-H, Random, 95% CI)0.93 [0.86, 1.00]
10.2 Unclear or high risk of bias123528Risk Ratio (M-H, Random, 95% CI)0.84 [0.68, 1.03]
11 Sensitivity analysis by risk of bias: stopping exclusive breastfeeding by 4-6 weeks247693Risk Ratio (M-H, Random, 95% CI)0.74 [0.61, 0.89]
11.1 Studies at low risk of bias145283Risk Ratio (M-H, Random, 95% CI)0.86 [0.75, 0.98]
11.2 Unclear of high risk of bias102410Risk Ratio (M-H, Random, 95% CI)0.59 [0.43, 0.80]
Analysis 1.1.

Comparison 1 All forms of support versus usual care, Outcome 1 Stopping breastfeeding (any) before last study assessment up to 6 months.

Analysis 1.2.

Comparison 1 All forms of support versus usual care, Outcome 2 Stopping exclusive breastfeeding before last study assessment.

Analysis 1.3.

Comparison 1 All forms of support versus usual care, Outcome 3 Stopping breastfeeding (any) at up to 4-6 weeks.

Analysis 1.4.

Comparison 1 All forms of support versus usual care, Outcome 4 Stopping exclusive breastfeeding at up to 4-6 weeks.

Analysis 1.5.

Comparison 1 All forms of support versus usual care, Outcome 5 Stopping any breastfeeding at different times.

Analysis 1.6.

Comparison 1 All forms of support versus usual care, Outcome 6 Stopping exclusive breastfeeding at different times.

Analysis 1.7.

Comparison 1 All forms of support versus usual care, Outcome 7 Duration of breastfeeding (mean number of days).

Analysis 1.8.

Comparison 1 All forms of support versus usual care, Outcome 8 Sensitivity analysis by risk of bias: stopping any breastfeeding at up to six months.

Analysis 1.9.

Comparison 1 All forms of support versus usual care, Outcome 9 Sensitivity analysis by risk of bias: stopping exclusive breastfeeding at up to six months.

Analysis 1.10.

Comparison 1 All forms of support versus usual care, Outcome 10 Sensitivity analysis by risk of bias: stopping any breastfeeding at 4-6 weeks.

Analysis 1.11.

Comparison 1 All forms of support versus usual care, Outcome 11 Sensitivity analysis by risk of bias: stopping exclusive breastfeeding by 4-6 weeks.

Comparison 2. All forms of support versus usual care: SUBGROUP ANALYSIS by who delivered the intervention
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Stopping any breastfeeding before last study assessment up to 6 months4014227Risk Ratio (M-H, Random, 95% CI)0.91 [0.88, 0.96]
1.1 Professional support269644Risk Ratio (M-H, Random, 95% CI)0.94 [0.88, 0.99]
1.2 Lay support93109Risk Ratio (M-H, Random, 95% CI)0.85 [0.77, 0.93]
1.3 Both professional and lay support51474Risk Ratio (M-H, Random, 95% CI)0.97 [0.91, 1.03]
2 Stopping exclusive breastfeeding before last study assessment3311961Risk Ratio (M-H, Random, 95% CI)0.86 [0.82, 0.91]
2.1 Professional support186537Risk Ratio (M-H, Random, 95% CI)0.93 [0.88, 0.98]
2.2 Lay support124350Risk Ratio (M-H, Random, 95% CI)0.74 [0.64, 0.87]
2.3 Both professional and lay support31074Risk Ratio (M-H, Random, 95% CI)0.76 [0.44, 1.32]
3 Stopping any breastfeeding at up to 4-6 weeks269148Risk Ratio (M-H, Random, 95% CI)0.86 [0.78, 0.94]
3.1 Professional support165685Risk Ratio (M-H, Random, 95% CI)0.84 [0.73, 0.95]
3.2 Lay support72541Risk Ratio (M-H, Random, 95% CI)0.88 [0.73, 1.06]
3.3 Both professional and lay support3922Risk Ratio (M-H, Random, 95% CI)0.87 [0.68, 1.11]
4 Stopping exclusive breastfeeding at up to 4-6 weeks247667Risk Ratio (M-H, Random, 95% CI)0.74 [0.61, 0.89]
4.1 Professional support154408Risk Ratio (M-H, Random, 95% CI)0.75 [0.57, 0.99]
4.2 Lay support72114Risk Ratio (M-H, Random, 95% CI)0.64 [0.45, 0.92]
4.3 Both professional and lay support21145Risk Ratio (M-H, Random, 95% CI)0.94 [0.89, 0.99]
Analysis 2.1.

Comparison 2 All forms of support versus usual care: SUBGROUP ANALYSIS by who delivered the intervention, Outcome 1 Stopping any breastfeeding before last study assessment up to 6 months.

Analysis 2.2.

Comparison 2 All forms of support versus usual care: SUBGROUP ANALYSIS by who delivered the intervention, Outcome 2 Stopping exclusive breastfeeding before last study assessment.

Analysis 2.3.

Comparison 2 All forms of support versus usual care: SUBGROUP ANALYSIS by who delivered the intervention, Outcome 3 Stopping any breastfeeding at up to 4-6 weeks.

Analysis 2.4.

Comparison 2 All forms of support versus usual care: SUBGROUP ANALYSIS by who delivered the intervention, Outcome 4 Stopping exclusive breastfeeding at up to 4-6 weeks.

Comparison 3. All forms of support versus usual care: SUBGROUP ANALYSIS by type of support
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Stopping any breastfeeding before last study assessment up to 6 months4014227Risk Ratio (M-H, Random, 95% CI)0.91 [0.88, 0.96]
1.1 Predominant telephone support3677Risk Ratio (M-H, Random, 95% CI)0.87 [0.65, 1.17]
1.2 Predominant face-to-face contact167859Risk Ratio (M-H, Random, 95% CI)0.90 [0.84, 0.96]
1.3 Balanced telephone and face-to-face support215691Risk Ratio (M-H, Random, 95% CI)0.93 [0.87, 0.99]
2 Stopping exclusive breastfeeding by last study assessment up to 6 months3311475Risk Ratio (M-H, Random, 95% CI)0.90 [0.87, 0.94]
2.1 Predominant telephone support2419Risk Ratio (M-H, Random, 95% CI)1.0 [0.99, 1.01]
2.2 Predominant face-to-face contact177113Risk Ratio (M-H, Random, 95% CI)0.81 [0.75, 0.88]
2.3 Balanced telephone and face-to-face143943Risk Ratio (M-H, Random, 95% CI)0.98 [0.94, 1.02]
3 Stopping any breastfeeding by 4-6 weeks248409Risk Ratio (M-H, Random, 95% CI)0.88 [0.81, 0.96]
3.1 Predominant telephone support2599Risk Ratio (M-H, Random, 95% CI)0.70 [0.31, 1.58]
3.2 Predominant face-to-face contact104178Risk Ratio (M-H, Random, 95% CI)0.82 [0.70, 0.95]
3.3 Balanced telephone and face-to-face123632Risk Ratio (M-H, Random, 95% CI)0.94 [0.84, 1.06]
4 Stopping exclusive breastfeeding by 4-6 weeks237044Risk Ratio (M-H, Random, 95% CI)0.72 [0.58, 0.90]
4.1 Predominant telephone support2419Risk Ratio (M-H, Random, 95% CI)0.96 [0.68, 1.35]
4.2 Predominant face-to-face contact123889Risk Ratio (M-H, Random, 95% CI)0.62 [0.51, 0.77]
4.3 Balanced telephone and face-to-face92736Risk Ratio (M-H, Random, 95% CI)0.94 [0.88, 1.01]
Analysis 3.1.

Comparison 3 All forms of support versus usual care: SUBGROUP ANALYSIS by type of support, Outcome 1 Stopping any breastfeeding before last study assessment up to 6 months.

Analysis 3.2.

Comparison 3 All forms of support versus usual care: SUBGROUP ANALYSIS by type of support, Outcome 2 Stopping exclusive breastfeeding by last study assessment up to 6 months.

Analysis 3.3.

Comparison 3 All forms of support versus usual care: SUBGROUP ANALYSIS by type of support, Outcome 3 Stopping any breastfeeding by 4-6 weeks.

Analysis 3.4.

Comparison 3 All forms of support versus usual care: SUBGROUP ANALYSIS by type of support, Outcome 4 Stopping exclusive breastfeeding by 4-6 weeks.

Comparison 4. All forms of support versus usual care: SUBGROUP ANALYSIS by timing of support
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Stopping any breastfeeding at last study assessment up to 6 months4014227Risk Ratio (M-H, Random, 95% CI)0.91 [0.88, 0.96]
1.1 Postnatal support alone279527Risk Ratio (M-H, Random, 95% CI)0.91 [0.86, 0.97]
1.2 Antenatal component to support134700Risk Ratio (M-H, Random, 95% CI)0.92 [0.86, 0.99]
2 Stopping exclusive breastfeeding by last assessment up to 6 months3211371Risk Ratio (M-H, Random, 95% CI)0.90 [0.86, 0.94]
2.1 Postnatal support alone217113Risk Ratio (M-H, Random, 95% CI)0.87 [0.81, 0.94]
2.2 Antenatal component to support114258Risk Ratio (M-H, Random, 95% CI)0.92 [0.87, 0.98]
3 Stopping any breastfeeding at 4-6 weeks248595Risk Ratio (M-H, Random, 95% CI)0.88 [0.81, 0.96]
3.1 Postnatal support alone176062Risk Ratio (M-H, Random, 95% CI)0.84 [0.75, 0.95]
3.2 Antenatal component to support72533Risk Ratio (M-H, Random, 95% CI)0.94 [0.84, 1.06]
4 Stopping exclusive breastfeeding at up to 4-6 weeks237044Risk Ratio (M-H, Random, 95% CI)0.72 [0.58, 0.90]
4.1 Postnatal support alone185425Risk Ratio (M-H, Random, 95% CI)0.68 [0.46, 1.02]
4.2 Antenatal component to support51619Risk Ratio (M-H, Random, 95% CI)0.88 [0.77, 1.01]
Analysis 4.1.

Comparison 4 All forms of support versus usual care: SUBGROUP ANALYSIS by timing of support, Outcome 1 Stopping any breastfeeding at last study assessment up to 6 months.

Analysis 4.2.

Comparison 4 All forms of support versus usual care: SUBGROUP ANALYSIS by timing of support, Outcome 2 Stopping exclusive breastfeeding by last assessment up to 6 months.

Analysis 4.3.

Comparison 4 All forms of support versus usual care: SUBGROUP ANALYSIS by timing of support, Outcome 3 Stopping any breastfeeding at 4-6 weeks.

Analysis 4.4.

Comparison 4 All forms of support versus usual care: SUBGROUP ANALYSIS by timing of support, Outcome 4 Stopping exclusive breastfeeding at up to 4-6 weeks.

Comparison 5. All forms of support versus usual care: SUBGROUP ANALYSIS by breastfeeding initiation
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Stopping any breastfeeding by last assessment up to 6 months3914071Risk Ratio (M-H, Random, 95% CI)0.92 [0.88, 0.96]
1.1 Settings with high breastfeeding initiation rates146549Risk Ratio (M-H, Random, 95% CI)0.90 [0.82, 0.98]
1.2 Settings with Intermediate initiation rates155396Risk Ratio (M-H, Random, 95% CI)0.94 [0.88, 1.00]
1.3 Settings with low initiation rates102126Risk Ratio (M-H, Random, 95% CI)0.92 [0.84, 1.00]
2 Stopping exclusive breastfeeding at last assessment up to 6 months3111185Risk Ratio (M-H, Random, 95% CI)0.90 [0.86, 0.94]
2.1 Settings with high breastfeeding initiation rates197606Risk Ratio (M-H, Random, 95% CI)0.83 [0.78, 0.89]
2.2 Settings with Intermediate initiation rates72210Risk Ratio (M-H, Random, 95% CI)0.89 [0.79, 1.01]
2.3 Settings with low initiation rates51369Risk Ratio (M-H, Random, 95% CI)1.00 [0.99, 1.01]
3 Stopping any breastfeeding at up to 4-6 weeks237804Risk Ratio (M-H, Random, 95% CI)0.87 [0.79, 0.96]
3.1 Settings with high breastfeeding initiation rates51897Risk Ratio (M-H, Random, 95% CI)0.69 [0.55, 0.85]
3.2 Settings with Intermediate initiation rates124369Risk Ratio (M-H, Random, 95% CI)0.93 [0.83, 1.05]
3.3 Settings with low initiation rates61538Risk Ratio (M-H, Random, 95% CI)0.89 [0.79, 1.00]
4 Stopping exclusive breastfeeding at up to 4-6 weeks226858Risk Ratio (M-H, Random, 95% CI)0.71 [0.56, 0.90]
4.1 Settings with high breastfeeding initiation rates113568Risk Ratio (M-H, Random, 95% CI)0.61 [0.47, 0.80]
4.2 Settings with Intermediate initiation rates61921Risk Ratio (M-H, Random, 95% CI)0.81 [0.68, 0.96]
4.3 Settings with low initiation rates51369Risk Ratio (M-H, Random, 95% CI)0.97 [0.86, 1.08]
Analysis 5.1.

Comparison 5 All forms of support versus usual care: SUBGROUP ANALYSIS by breastfeeding initiation, Outcome 1 Stopping any breastfeeding by last assessment up to 6 months.

Analysis 5.2.

Comparison 5 All forms of support versus usual care: SUBGROUP ANALYSIS by breastfeeding initiation, Outcome 2 Stopping exclusive breastfeeding at last assessment up to 6 months.

Analysis 5.3.

Comparison 5 All forms of support versus usual care: SUBGROUP ANALYSIS by breastfeeding initiation, Outcome 3 Stopping any breastfeeding at up to 4-6 weeks.

Analysis 5.4.

Comparison 5 All forms of support versus usual care: SUBGROUP ANALYSIS by breastfeeding initiation, Outcome 4 Stopping exclusive breastfeeding at up to 4-6 weeks.

Comparison 6. All forms of support vs usual care: SUBGROUP ANALYSIS by number of postnatal contacts
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Stopping any breastfeeding before last study assessment up to 6 months4014227Risk Ratio (M-H, Random, 95% CI)0.91 [0.88, 0.96]
1.1 Unspecified number of contacts52747Risk Ratio (M-H, Random, 95% CI)0.94 [0.87, 1.02]
1.2 Less than 4 postnatal contacts103667Risk Ratio (M-H, Random, 95% CI)0.91 [0.82, 1.01]
1.3 Between 4 and 8 postnatal contacts133183Risk Ratio (M-H, Random, 95% CI)0.85 [0.75, 0.96]
1.4 9 or more postnatal contacts124630Risk Ratio (M-H, Random, 95% CI)0.94 [0.88, 1.01]
2 Stopping exclusive breastfeeding before last study assessment3311961Risk Ratio (M-H, Random, 95% CI)0.86 [0.82, 0.91]
2.1 Unspecified number of contacts21102Risk Ratio (M-H, Random, 95% CI)0.99 [0.88, 1.11]
2.2 Less than 4 postnatal contacts82550Risk Ratio (M-H, Random, 95% CI)0.92 [0.84, 1.01]
2.3 Between 4 and 8 postnatal contacts133943Risk Ratio (M-H, Random, 95% CI)0.71 [0.60, 0.84]
2.4 9 or more postnatal contacts104366Risk Ratio (M-H, Random, 95% CI)0.88 [0.78, 0.99]
3 Stopping any breastfeeding at up to 4-6 weeks258513Risk Ratio (M-H, Random, 95% CI)0.88 [0.81, 0.96]
3.1 Unspecified number of contacts41943Risk Ratio (M-H, Random, 95% CI)0.94 [0.83, 1.06]
3.2 Less than 4 postnatal contacts103949Risk Ratio (M-H, Random, 95% CI)0.83 [0.70, 0.97]
3.3 Between 4 and 8 postnatal contacts5554Risk Ratio (M-H, Random, 95% CI)0.80 [0.56, 1.15]
3.4 9 or more postnatal contacts62067Risk Ratio (M-H, Random, 95% CI)0.92 [0.77, 1.11]
4 Stopping exclusive breastfeeding at up to 4-6 weeks247693Risk Ratio (M-H, Random, 95% CI)0.74 [0.61, 0.89]
4.1 Unspecified number of contacts31284Risk Ratio (M-H, Random, 95% CI)0.91 [0.78, 1.06]
4.2 Less than 4 postnatal contacts92906Risk Ratio (M-H, Random, 95% CI)0.90 [0.84, 0.96]
4.3 Between 4 and 8 postnatal contacts5556Risk Ratio (M-H, Random, 95% CI)0.52 [0.31, 0.87]
4.4 9 or more postnatal contacts72947Risk Ratio (M-H, Random, 95% CI)0.69 [0.28, 1.74]
Analysis 6.1.

Comparison 6 All forms of support vs usual care: SUBGROUP ANALYSIS by number of postnatal contacts, Outcome 1 Stopping any breastfeeding before last study assessment up to 6 months.

Analysis 6.2.

Comparison 6 All forms of support vs usual care: SUBGROUP ANALYSIS by number of postnatal contacts, Outcome 2 Stopping exclusive breastfeeding before last study assessment.

Analysis 6.3.

Comparison 6 All forms of support vs usual care: SUBGROUP ANALYSIS by number of postnatal contacts, Outcome 3 Stopping any breastfeeding at up to 4-6 weeks.

Analysis 6.4.

Comparison 6 All forms of support vs usual care: SUBGROUP ANALYSIS by number of postnatal contacts, Outcome 4 Stopping exclusive breastfeeding at up to 4-6 weeks.

Appendices

Appendix 1. Methods used to assess trials included in previous versions of this review

Titles and abstracts of the electronic searches were assessed for inclusion by a review author and a research assistant (Felicia McCormick (FM), Natasha Danson). All the included trials offered an intervention to breastfeeding women with the purpose of encouraging continued breastfeeding. All articles identified were available in English. Two review authors independently read articles identified via the search strategy to determine inclusion or exclusion (Cathryn Britton (CB), FM). Any differences in opinion were resolved in consultation with a third author (Mary Renfrew). When information regarding the study was unclear, we attempted to contact authors of original reports to provide further details. Angie Wade and Sarah King provided statistical advice and review.

We designed a data extraction form. Two authors (CB, FM) used data extraction forms and quality appraisal forms independently. One author extracted and the second author checked the data. Disagreements were resolved through discussion between the authors. We identified 34 randomised or quasi-randomised controlled trials from 14 countries as eligible for inclusion in this review. We extracted the following study characteristics and entered them in the table of included studies: country, setting, demographic data on study group and controls, study design, randomisation procedure, intervention package, length and completeness of follow-up, description of withdrawals and drop-outs, blinding of assessors and outcome measures. We used Review Manager software (RevMan 2003) to double enter all the data.

We assessed the method of allocation concealment used in each study using criteria outlined in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2005). We categorised studies according to whether the method of allocation concealment reported was judged to have been adequate (A), unclear (B) inadequate (C), or if allocation was not concealed (D). We also checked study reports for clear descriptions of inclusion and exclusion criteria; randomisation methods; withdrawals and drop-outs; statistical analysis used; blinding of outcome assessment; and intention-to-treat analysis. Methods used for generation of the randomisation sequence are described in the 'Characteristics of included studies' table. Included trials had a minimum of 75% initial follow-up. When included trials reported data at more than one time point and follow-up rates fell, we included only data from time points where follow-up rates were at least 75% in the analysis.

We carried out statistical analysis using RevMan 2003. We analysed data on an intention-to-treat basis whenever possible, even if intention-to-treat analysis had not been used in the study report. When cluster-randomised trials were incorporated, we calculated effective sample sizes and entered these into the meta-analyses. We determined effective sample sizes via calculation of the intraclass correlation coefficient, where the data were available, or through consideration of the relative sizes of the confidence intervals obtained from analyses which did and did not correct for clustering of the outcomes.

We calculated relative risk as the preferred estimate of treatment effect. We preferred random-effects models to perform all meta-analyses since studies were clinically heterogeneous. We also undertook subgroup analyses of all studies offering support compared with those that had adequate allocation concealment; studies in settings with high, medium and low baseline breastfeeding initiation rates; support offered by professional, lay or a combination of professional and lay supporters; face-to-face, phone or balanced telephone and face-to-face contact; and postnatal support alone or support with an antenatal component.

What's new

Last assessed as up-to-date: 2 April 2012.

DateEventDescription
12 December 2011New citation required but conclusions have not changedThe update was prepared by a new author team. Studies were carried out in 21 countries. Overall conclusions have not changed, but we include more evidence on the effect of interventions in different settings and for different types of interventions; proactive interventions that rely mainly on face-to-face support are more likely to succeed.
12 December 2011New search has been performedIn the previous version of this review (Britton 2007) we included 34 trials in 14 countries. In this updated version, we assessed 218 reports; corresponding to 150 separate studies. We have included 67 studies and excluded 79. Four studies are still ongoing or awaiting further assessment. In this updated version we have added further subgroup analysis and discuss the impact of different types of support interventions.

History

Protocol first published: Issue 3, 1998
Review first published: Issue 1, 1999

DateEventDescription
27 July 2009AmendedSearch updated, 68 reports added to Studies awaiting classification.
6 November 2008AmendedConverted to new review format.
30 January 2006New search has been performedSearches updated. We have included fourteen new studies and excluded an additional 30 studies.
30 January 2006New citation required and conclusions have changed

New review team prepared this update.

Previous versions of this review categorised support as 'professional' or 'lay'. This edition introduces a new category: combined lay and professional support. Studies in this category demonstrated a significant effect on duration of any breastfeeding, especially in the first two months.

Contributions of authors

This update is based on the previous Cochrane review (Britton 2007).

Mary Renfrew was co-author of all the earlier versions of this review. In this update of the review she contributed to planning its restructure, assessment of study eligibility, analysis, drafting text for the Background, Discussion and Conclusions, and commented on review drafts.

Felicia McCormick was co-author of Britton 2007. In this version she contributed to planning its restructure, assessment of study eligibility, data extraction and analysis, drafting text for the Description of included studies, and commented on review drafts.

Angie Wade provided statistical advice for this and all the earlier versions of this review. She advised about including cluster-randomised trials in the analyses and commented on review drafts.

Beverly Quinn was involved in this update and contributed to assessment of study eligibility, data extraction, and commented on drafts.

Therese Dowswell was involved in this update and contributed to planning its restructure, assessment of study eligibility and data extraction. She set up the analyses, drafted text for the Methods and Results sections and commented on review drafts.

Declarations of interest

None declared.

Sources of support

Internal sources

  • University of York, UK.

External sources

  • UK Medical Research Council, UK.

  • NIHR, UK.

    TD is supported by the NIHR NHS Cochrane Collaboration Programme grant scheme award for NHS-prioritised centrally-managed, pregnancy and childbirth systematic reviews: CPGS 10/4001/02

Differences between protocol and review

The methods section has been updated and the review now focuses on healthy mothers with healthy term infants.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Aidam 2005

MethodsRCT, 3-arm trial with individual randomisation.
Participants

The study was carried out in the Tema area of Ghana (sub-Saharan Africa). Women were recruited in prenatal clinics in 2 hospitals (1 government and 1 private). The study hospitals served urban areas (an industrial city and a commercial town).

High baseline prevalence of breastfeeding. In Ghana, the median duration of breastfeeding was reported as being 22 months and 53.4% of women with babies less than 6 months breastfeeding exclusively. It was reported that "almost all" mothers initiated  breastfeeding.

231 women randomised (136 eligible at the beginning of the intervention period).

Inclusion criteria: pregnant women in the last trimester planning delivery in the study hospitals and to stay in study area for 6 months after delivery. After delivery: singleton babies with normal birthweight (> 2500 g) and Apgar scores 6 or more at 1 and 5 min.

Exclusion criteria: multiple birth, low Apgar score or planning to move out of area.

Maternal education: 38% of the women had only primary level or no formal education; 90% of the women were married or living with a partner; 46% of the women were primiparous; 73% of the women had vaginal birth; 24% lived in households with access to a car; 74% were described as Trader/Artisan.

Interventions

All 3 groups (Intervention group 1, Intervention group 2 and control group) were allocated to 2 educational group sessions during pregnancy by trained nurses and 9 proactive home visits by trained nurse counsellors at 1, 2, 4, 6, 8, 12, 16, 20 and 24 weeks postpartum. These were additional to standard care. The content of the sessions differed between the 3 groups. 63% of group 1, 73% of group 2 and 65% of control group women received all 9 scheduled home follow-up visits.

Control group: 85 randomised, 49 followed up. Content of sessions was general health and childcare topics such as immunisation, HIV/AIDS, nutrition and family planning.

Intervention group 1: 74 randomised, 43 followed up. Content of sessions was breastfeeding and exclusive breastfeeding. The 2 educational sessions, of approximately 20 minutes each, were given by trained local nurses with experience of breastfeeding to groups of 2-4 women during the 3rd trimester. At the postpartum home visits women received individual counselling and nurses were advised to respond to concerns. Materials were developed from WHO/UNICEF breastfeeding counselling training manual.

Intervention group 2: 72 randomised, 44 followed up. Content of the pregnancy sessions was general health and childcare as for control group. Content of the postpartum home visits was breastfeeding and exclusive breastfeeding as for intervention group 1.

OutcomesBreastfeeding status at 1, 2, 3, 4, 5, and 6 months exclusive breastfeeding up to 6 months, infant morbidity and growth.
NotesWe have not included data from this study in the review due to high levels of attrition (> 25% loss to follow-up). Most data were reported in graphs and difficult to interpret. Several measures of exclusive breastfeeding were reported; at 1 and 6 months women were asked about breastfeeding since birth, during previous month and on previous day. In this review we have reported figures for exclusive breastfeeding since birth for both time points. Figures in the paper were expressed as percentage of women still exclusively breastfeeding; in order to use the data we used subtraction to calculate a figure for women who had stopped breastfeeding.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk“Randomization was achieved by writing numbers 1 to 3 on folded pieces of paper."
Allocation concealment (selection bias)High risk

"The numbers were not viewed by either study staff or mothers and the pieces of paper looked the same on the outside. Before offering papers to mothers, they were shuffled in the interviewer’s palm.”

“The randomisation scheme used was not a formal one. It was one that could be conducted easily in the field. Despite this, it functionally produced balanced groups with no evidence of bias.” 

Blinding (performance bias and detection bias)
outcome assessors
High risk

Participants: "were not aware of their group allocation or of differences in the content of the health education. " However, women in all 3 intervention arms received an intervention. Women would be aware that they had received an intervention although they may not have been aware of what women in other groups received.

Staff: "It was impossible to keep counsellors unaware of study design.... research assistants [collecting outcome data] were aware of mothers group allocation."

Incomplete outcome data (attrition bias)
All outcomes
High risk

231 women randomised during the 3rd trimester. At delivery 95 women were excluded as they were no longer eligible (41% lost before the intervention). A further 13 women were lost to follow-up during the intervention period.  123 completed the final follow-up at 6 months (i.e. 53% of the original randomised sample but 90% of those still eligible at delivery).

Results were reported in graphs and percentages and it was not clear how many women commenced breastfeeding, so group denominators are not clear.

Loss to follow-up appeared balanced across groups.

Selective reporting (reporting bias)Unclear riskFailure to provide denominators for results means that they are very difficult to interpret.
Other biasUnclear riskWomen in the 3 arms of the trial appeared similar at baseline. Analysis was according to group allocation.

Aksu 2011

MethodsRCT (n = 66) single site, a Baby-Friendly hospital, March to July 2008.
Participants

Urban state maternity hospital in Turkey. Background rates of breastfeeding initiation: high.

Inclusion criteria: primaparous, live vaginal birth, healthy term singleton infant, lives in study area, speaks Turkish, no history of chronic diseases, non-smoker, intends to breastfeed. Exclusion criteria: infant birthweight < 2500 g, Apgar score ≤ 7, congenital anomalies, serious disease or needing intensive care. Baseline prevalence of "ever breastfed" in Turkey: 96.7% (WHO Global data bank 2010, accessed 6.10.2011).

Interventions

At this Baby-Friendly hospital, a standard breastfeeding education session lasting 20-30 minutes was provided to all mothers before standard discharge home at 24 hours after the birth. The session included the topics covered by the 18h WHO/Unicef training.

The intervention group received standard breastfeeding support plus support from trained lay supporters who had undergone WHO/UNICEF 18 h training. The intervention was a single home visit on day 3 after the birth (in hospital), by 2 lay breastfeeding, that lasted about 30 minutes and covered the same topics as routine support.

OutcomesExclusive breastfeeding at 2 and 6 weeks and 6 months postpartum; breastfeeding duration (any/exclusive) to 18 months; breastfeeding knowledge scores at 2 and 6 weeks postpartum.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer-generated random numbers.
Allocation concealment (selection bias)Unclear riskNot described.
Blinding (performance bias and detection bias)
outcome assessors
Unclear riskNot described.
Incomplete outcome data (attrition bias)
All outcomes
Low risk82% follow-up at 18 months. Reasons for loss were explained and were balanced across groups.
Selective reporting (reporting bias)Low riskNot apparent.
Other biasLow riskGroups appeared similar at baseline.

Albernaz 2003

MethodsPrimary care facilities. Recruitment over 5 months, n = 169.
Participants3 hospitals in the city of Pelotas, in southern Brazil. Background rates of breastfeeding initiation: high. Ethnic composition not described. Inclusion criteria: term healthy baby, family income at least US $500 per month (no economic constraints to baby's growth), mother intends to breastfeed and does not smoke. Baseline prevalence of breastfeeding in Brazil in the first 30 days = 88%.
Interventions

Control: attended paediatric clinics where general advice on advantages of breastfeeding may have been offered, but specific lactation counselling was not provided.

Intervention: hospital visit, home visits at 5, 15, 30, 45, 90 and 120 days, and 24 hour telephone hotline for help or to arrange visits. 2 members of the lactation support team had received the 40 h WHO lactation support training course.

OutcomesBreastfeeding pattern and duration up to age 4 months. Breastmilk intake for a subgroup of 68 infants at 4 months.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer-generated code.
Allocation concealment (selection bias)Low riskSealed envelopes.
Blinding (performance bias and detection bias)
outcome assessors
Unclear riskIt was stated that different field-workers delivered the intervention and collected outcome data; but it was not clear whether this attempt at blinding was successful.
Incomplete outcome data (attrition bias)
All outcomes
High risk188 women were randomised. 21 were excluded after 2 weeks as they had introduced formula. A further 26 withdrew (some data were available for some of these women). 141 women completed the trial (75%).
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskExcluding women who introduced formula within 2 weeks of randomisation is likely to have introduced bias although similar numbers were excluded from both groups (9 women lost from the intervention group for this reason and 11 women from the control group and an additional control was withdrawn for smoking).

Anderson 2005

MethodsRCT, 2 arms with individual randomisation.
Participants

Hartford area of Connecticut, USA in a hospital providing care for predominantly Latina low-income women.

Inclusion criteria: age 18 years or older; gestational age less than 32 weeks at first approach; healthy, considering breastfeeding, planning delivery at study hospital and resident in area for 3 months after the birth, 185% of the federal poverty level, available for telephone contact and willing to participate.

Exclusion criteria: Mothers - medical conditions such as diabetes or hypertension; drug use that could impair breastfeeding. Infants - preterm, low birthweight (< 2500 g) baby, any complications requiring admission to special care, Apgar score < 7 at 1 and 5 minutes.

Participant characteristics: at baseline: intervention n = 63; control n = 72.

Age: intervention 68%; control 66%; Married/cohabiting: intervention 40%; control 26%; Hispanic race: intervention 81%; control 64%; Education < high school: intervention 31%; control 38%; Received welfare: intervention 31%; control 38%; Primiparous: intervention 92%; control 89%; Planned breastfeeding duration:- Less than 6 months: intervention 20%; control 46%; 6-12 months or longer: intervention 80%; control 54%.

Interventions

Control group received what would have been standard care for private patients (these women may not have normally qualified to receive this care as many were participating in welfare programmes). This consisted of: breastfeeding support line open to mothers after delivery staffed by lactation specialist. Usual inpatient care and support for breastfeeding was provided by hospital staff.

Intervention group received in addition 3 prenatal home visits, daily in-hospital visits and 9 postpartum home visits from peer counsellors, scheduled 3 in first week, 2 in second week and 1 in each week 3-6. Women could also phone peer counsellors. Peer counsellors were mothers from the area with experience of successful breastfeeding and training from lactation consultant.

OutcomesInfant feeding practices (weekly for first month) breastfeeding and exclusive breastfeeding. Infant morbidity (diarrhoea and ear infection). Breastfeeding outcomes measured in 3 different ways – over the past 24 hours, over the past week and since the birth (ever given).
NotesWe have not included data from this study in the review due to high levels of attrition (> 25% loss to follow-up).
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskSPSS software was used to randomly assign subjects to study groups.
Allocation concealment (selection bias)Low risk

"Recruited subjects were entered into the database at the end of every week” and then random allocation by computer software.

 

Blinding (performance bias and detection bias)
outcome assessors
Unclear riskBlinding not attempted, women, staff and outcome assessors were likely to have been aware of group assignments.
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk182 women were recruited and randomised. 162 were still eligible at delivery and 135 completed the trial (84% of those still eligible at delivery and 74% of the total randomised).
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskGroups appeared similar at baseline although women in the control group were more likely (46%) to plan to breastfeed for less than 6 months than women in the intervention group (20.4%). This difference in breastfeeding intentions mean that results are more difficult to interpret.

Barros 1994

MethodsRCT 2-arm trial. Single-site study, n = 900.
ParticipantsUrban setting in Brazil: in-patient maternity unit. Background rates of breastfeeding initiation: High. Ethnic composition not described. Inclusion criteria: family income less than twice the minimum Brazilian wage; hospital stay less than 5 days; wanting to breastfeed: living within the city of Pelotas. Baseline prevalence in Pelotas (1993) for any breastfeeding: 85% at 1 month, 66% at 3 months and 38% at 6 months.
Interventions

In usual care, a social assistant would not normally make routine home visits but would visit only when requested to do so by the hospital team.

Intervention: 3 home visits at 5, 10 and 20 days postpartum by a social assistant or nutritionist. The visitor was required to have a personal history of successfully breastfeeding a child and received training in breastfeeding physiology and common breastfeeding problems and their solutions.

OutcomesBreastfeeding at monthly intervals to 6 months and median duration of breastfeeding. Time to introduction of artificial feeds. Difficulties encountered during breastfeeding and reasons for weaning also recorded.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot described.
Allocation concealment (selection bias)Unclear riskNot described.
Blinding (performance bias and detection bias)
outcome assessors
High riskThe nurse collecting outcome data was not aware of previous contacts but the authors state that s/he may have been made aware of group assignment as women were likely to talk about the intervention.
Incomplete outcome data (attrition bias)
All outcomes
Low risk900 randomised, approximately 8% lost to follow-up in the interventions and control groups.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskNo baseline imbalance apparent. Assessment of risk of bias was made from translation notes. The original paper is in Portuguese.

Bashour 2008

MethodsRandomised controlled trial, 3-arm trial with individual randomisation.
Participants

Recruited from Maternity Teaching Hospital in Damascus, Syria. Background rates of breastfeeding initiation: High.

Inclusion criteria: consenting women who delivered a healthy newborn whether by vaginal delivery or caesarean section, who lived within 30 km from hospital, and who were available for the follow-up for the coming 6 months.

Exclusion criteria (infants): premature, low birthweight (< 2500 g), with apparent congenital anomalies.

Participant characteristics: age not clear. Approximately 37% primiparous, 90% had normal labour, more than 99% of the women married. Home conditions were described as bad (number of rooms, poor sanitation or water, etc) in 28.5% of control group and approximately 20% of the intervention groups. Few of the women (approximately 5%) worked outside the home.

Interventions

Control group received standard care in Syria (no postnatal visits).

Intervention group 1 (301 randomised): 4 structured home visits from trained midwives at 1, 3 and 7 days and 4 weeks after the birth. Midwives examined mothers and infants and provided and advice and support on a range of healthcare issues including breastfeeding support and education.

Intervention group 2 (301 randomised) a single postnatal visit from a trained midwife at 3 days which included advice and education on breastfeeding.

Outcomes

Primary outcomes: maternal postpartum morbidities, postnatal care uptake, contraceptive uptake and type, infant morbidities, infant immunisation according to the national schedule at 3 months and Infant feeding, namely exclusive breastfeeding during the first 4 months of life.

Secondary outcomes: women’s perceptions of their health, impressions about the home visit and perceptions of its quality.

NotesSome baseline imbalance, women in the control groups were more likely to have poor home conditions and were less likely to have received antenatal care.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskParticipants were randomised into blocks to either of the intervention groups (4 home visits or 1 home visit) or to the control group (no home visits). Randomisation was in blocks of 7 where a caseload of 21 eligible deliveries per day was assumed, based on the average daily number of deliveries in the hospital (ranging from 30 to 35) after excluding non-eligible cases.
Allocation concealment (selection bias)Low riskNumbered, opaque and sealed envelopes..”  Group allocation was carried out by a senior midwife not involved in the rest of the study.
Blinding (performance bias and detection bias)
outcome assessors
High riskParticipants and caregivers were not blinded. For outcome assessors it states that the interviewers carrying out outcome assessment were not informed of groups but would be aware of which group women were in from the interviews.
Incomplete outcome data (attrition bias)
All outcomes
Low risk903 women met the inclusion criteria. After randomisation (301 in each arm), 27 women were excluded (18 due to lack of address detail and 9 refusals). A total of 876 women were followed up in the 3 study groups: Group A (285 women); Group B (294 women) and Group C (297 women). Incomplete data were addressed.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskSome baseline imbalance, women in the control groups were more likely to have poor home conditions and were less likely to have received antenatal care. Outcome data were collected at 4 months, but it is likely that there may have been recall bias for some outcomes, e.g. breast engorgement – women in the intervention groups will have discussed this and maybe it was recorded at the time it occurred, women in the control group will not have been asked until 4 months postpartum. Outcome data were collected for a large number of variables so any differences may have occurred by chance.

Bhandari 2003

MethodsCluster-randomised study with 8 sites, n = 1115.
Participants8 village communities located 3-5 km from the main highway in Haryana, India. Background rates of breastfeeding initiation: High. Inclusion criteria: born in a study village within 9 months of start of intervention. Baseline breastfeeding prevalence stated to be high.
Interventions

At the control sites, the research team provided routine services, in which, according to national policy, workers are required to advise exclusive breastfeeding for 4-6 months.

Health and nutrition workers in the intervention communities received training based on Integrated Management of Childhood Illnesses Training Manual on Breastfeeding Counseling (WHO 1997). Messages - feed only breast milk for first 6 months of life; breastfeed the infant day and night, at least 8 times in 24 h; possible adverse effects of other foods and fluids given to breastfeeding infants - given to mothers at birth, monthly home visits, immunisation clinics and neighbourhood meetings.

OutcomesFeeding at 3 months.
Anthropometry and diarrhoea prevalence at 3 and 6 months.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskCommunities were paired on the basis of similar scores for socio-economic, mortality and morbidity indicators. 1 of each pair was allocated to the intervention using a random numbers table. 8 areas randomised (4 to each condition).
Allocation concealment (selection bias)Low riskStatistician independent of project carried out randomisation.
Blinding (performance bias and detection bias)
outcome assessors
High riskWomen, staff and outcome assessors all aware of intervention.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskReasons for drop-out recorded. 1151 births within the study period (not clear how many in each area). 588 families received the intervention and 527 no intervention. 895 completed 3 months follow-up (80%) and 880 6 months (79%).
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskAreas were paired but it was not clear whether or not this achieved similar baseline characteristics between groups. Results were reported to have been adjusted for clustering.

Bloom 1982

MethodsRCT, 2 arms randomised, individual randomisation (although the study also included a non-randomised comparison group).
Participants

100 breastfeeding mothers randomised; recruited 3 days after the birth.

Inclusion criteria:  married, primiparous with healthy infants born at a maternity hospital in Nova Scotia, Canada.

Exclusion criteria: infants with birthweight < 2500 g, with Apgar scores less than 5, twins, women having operative deliveries, women who did not speak English.

Interventions

Women in both groups received a pamphlet on breastfeeding. Women in the control group received usual care (not specified).

Intervention: weekly telephone calls beginning 10 days after the birth made by a nurse interviewer, offering support and advice and referral if necessary. Calls lasted 5-10 minutes and were described as friendly. Women received up to 3 calls up to 6 weeks postpartum. Calls ceased when women discontinued breastfeeding.

OutcomesInterviews at 6 weeks postpartum. Women were asked about infant behaviour and infant feeding and breastfeeding duration.
NotesWe have not included data from this study, because results in this paper were not reported in a form in which we could use them in the review. Most of the results were not reported according to randomisation group (rather authors described factors and associations with e.g. breastfeeding). Breastfeeding in the randomised groups at 6 weeks was not reported and it was not possible to contact the authors to obtain this information. It was stated that average breastfeeding duration was 28.6 days in the intervention group vs 21.0 days for controls, but no standard deviations were reported. It was not clear when or how breastfeeding duration data were collected; if at the 6 week postpartum interviews this suggests that figures for average breastfeeding duration only apply to those women who had discontinued breastfeeding and denominators are therefore not clear.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot described.
Allocation concealment (selection bias)Unclear riskDescribed as “randomly assigned”.
Blinding (performance bias and detection bias)
outcome assessors
Unclear riskThe interviewer who recruited women also carried out the intervention. The interviewer carrying out outcome assessment was reported not to be aware of the initial feeding choice (but may have been made aware of the intervention allocation by women).
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskRates of follow-up at 6 weeks were high (97%). However, denominators for breastfeeding duration results were not reported.
Selective reporting (reporting bias)Unclear riskMost results were not reported by randomisation group and are difficult to interpret.
Other biasUnclear riskUnclear - no baseline characteristics table for randomised groups.

Bonuck 2005

MethodsRCT, 2-arm trial, n = 382 women randomised.
Participants

From 2 prenatal care centres in the Bronx, New York (reported to be the US county with the highest poverty rate). Background rates of breastfeeding initiation: Low.

Inclusion criteria: speaks English or Spanish, singleton or twin pregnancy <24 weeks (twins subsequently excluded), intending to keep infant and attend for prenatal and postnatal care at centre and affiliated hospital, telephone contact numbers available.

Exclusion criteria: HIV positive status, chronic disease with medication not compatible with breastfeeding, diabetes, serious illness, or breast reduction surgery.

Participant characteristics: 57% Hispanic, 36% African American, 62% multiparous (70% of these had previous breastfeeding experience), mean age 25 years (SD 6.23), 51.5% married or living with a partner, 57% receiving Medicaid.

Interventions

Control group (194 randomised): Women in the control group had no contact with the lactation consultant. Standard care varied between the sites and neither site followed an established protocol for breastfeeding. Women enrolled in women and child nutrition programmes (WIC) had the opportunity to visit a breastfeeding coordinator.

Intervention group (188 randomised). The intervention was by a trained lactation consultant. Women recruited before they were 24 weeks pregnant had 2 prenatal lactation consultant visits scheduled. During late pregnancy there was telephone contact, and hospital and home visits and telephone support (up to 12 months postpartum) were planned for the postnatal period. In the postnatal period 25% of the intervention group received at least 1 hospital contact; approximately 50% had telephone and/or home visits; but 36% received no home or hospital visits and no telephone support.

OutcomesInfant health outcomes. Duration of breastfeeding and exclusive breastfeeding was presented mostly in graphical form and was difficult to interpret. Breastfeeding was categorised on a 7-point scale from 7 exclusive breastfeeding (which was defined as no other milk or food, but infants may have received water and other liquids) through to exclusive formula, between there were various “intensities” of breastfeeding (e.g. more than 50% breast milk). This means results are complicated and not easy to interpret. Women were followed up to 12 months and detailed (graphical) weekly data are reported for weeks 1-26 postpartum.
NotesResults estimated from graphs.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk“The project’s biostatistical office generated and maintained a list of random codes for subjects... undisclosed blocking factor and stratification according to center”.
Allocation concealment (selection bias)Low riskSealed envelopes, numbered and opened sequentially.
Blinding (performance bias and detection bias)
outcome assessors
High risk“Neither the RA [research assistant] collecting breastfeeding outcome data nor the LC [lactation consultant] providing the intervention were blind with respect to treatment group.”
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskWomen were recruited in the antenatal period. 382 women were randomised.  Loss to follow-up included 10 women who miscarried or terminated the pregnancy. 304 women were followed up into the postnatal period (80% of those randomised).  There was further missing data for longer term follow-up. Loss to follow-up was balanced across groups.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskThe intervention did not appear to be standardised and many women in the intervention group (36%) did not receive any postnatal visits.

Brent 1995

MethodsSingle-site study. Duration not stated, n = 115. RCT. 2-arm trial with individual randomisation.
Participants

Urban USA - ambulatory care centre and in-patient maternity unit. Background rates of breastfeeding initiation: Low. Baseline prevalence of breastfeeding at birth in national WIC sample = 33% (1991).

Inclusion criteria: English speaking; nulliparous. Exclusion criteria: separated from child at birth; preterm delivery; child in NICU longer than 72 hours. Ethnic composition: described as 71% white. 90% of participants were eligible for WIC programmes for those on low income. Study population not limited to those intending to breastfeed.

Interventions

Control group were offered optional prenatal breastfeeding classes, postpartum breastfeeding instruction by nurses and physicians and out-patient follow-up by nurses and physicians in the paediatric ambulatory department.

Intervention: package of: 2-4 prenatal sessions with lactation consultant (10-15 minutes each); telephone call 48 hours after discharge; visit to lactation clinic at 1 week postpartum (staffed by paediatrician or lactation consultant); contact with lactation consultant at each health supervision visit until weaning or 1 year; professional education of nursing and medical staff.

OutcomesRates of breastfeeding at 2 months and median duration of breastfeeding.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskSample stratified by age with block randomisation in blocks of 8.
Allocation concealment (selection bias)Unclear riskNot described.
Blinding (performance bias and detection bias)
outcome assessors
High riskOutcome assessment not independent of intervention. Outcome data were collected by questionnaire administered by the lactation consultant who was not blind to group allocation.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskFollow-up 94%. It appeared that 115 women were randomised. It was stated that 7 in  the intervention were excluded as they did not receive the intervention. 8 women in the control group were subsequently excluded from the analysis for at least some outcomes as the treatment they received deviated from protocol.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskPotential confounders: women were excluded from intervention group following randomisation if they had received fewer than 2 prenatal lactation consultations; ITT analysis not performed (8 women in control group who met lactation consultant excluded); intervention included input by staff caring for both intervention and control groups.

Bunik 2007

MethodsRCT, 2-arm trial with individual randomisation (n = 339) with add-on qualitative study.
Participants

Denver, USA; a clinic providing care for a predominantly Hispanic, medically underserved population. Background rates of breastfeeding initiation: Low.

Inclusion criteria: women aged 18 years or older, primiparous with healthy, term, singleton baby who were willing to consider breastfeeding.

Exclusion criteria: primary language not English or Spanish, medical complication that interfered with breastfeeding, hospital stay longer than 72 hours following vaginal births or longer than 96 hours following caesarean section, baby with medical problems, admitted to NICU or had a hospital stay longer than 72 hours.

Participant characteristics: Mean age 22 years; 88% Hispanic or Latino; 77% vaginal delivery. Planned to breastfeed only: Intervention group 50%, control group 55% (other women planned to combine breastfeeding with formula). More than 60% were participating in WIC programmes at 1 month and 74% of these women were provided with formula at WIC clinics.

Interventions

Control: usual hospital care (pamphlets on breastfeeding, a breast pump, lanolin cream and a water bottle); usual discharge care (commercial discharge packs) and scheduled healthcare visits at 3-5 days and at 2 weeks at the local community health centre.

Intervention: telephone support daily, from the day following hospital discharge until 2 weeks postpartum, from trained nurses following a specific protocol covering advantages and disadvantages of breastfeeding, cultural issues, technique, problems and with referral for any lactation or medical problems.

OutcomesAny breastfeeding or predominantly breastfeeding. Maternal satisfaction, healthcare utilisation, reasons for stopping breastfeeding.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer-generated block random allocation.
Allocation concealment (selection bias)Low riskSequentially numbered opaque sealed envelopes.
Blinding (performance bias and detection bias)
outcome assessors
Unclear riskNo blinding for participants or caregivers and not described for outcome assessors.
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk341 women were randomised. At 1 month there approximately 8% loss to follow-up. By 6 months 27% loss. 73% were described as included in the analyses; women in the intervention group that did not receive the intervention as planned were not included.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskGroups appeared similar at baseline.

Caldeira 2008

MethodsStudy methods were not clear. This appeared to be a cluster-randomised trial in 35 clinics.The intervention was carried out with healthcare workers. Results are for women attending intervention and control clinics before and after the intervention period.
Participants

Setting: family healthcare teams from Montes Claros city in South East Brazil.

Baseline prevalence of breastfeeding initiation in country/setting: not clear.

1423 women (unclear). Follow-up for 12 months.

Inclusion criteria: mothers with children between 0 and 2 years old registered with the family health teams.

Approximately 20% under 20 years, 38% primiparous, 27% vaginal deliveries, 90% more than 4 years education. 

Interventions

Control: healthcare teams (n = 15 - unclear) in control clinics did not receive the training

Intervention: 20 healthcare teams received staff training to promote breastfeeding, based on the Baby Friendly Hospital Initiative. Duration of the intervention unclear; there was an initial interview before the study and a second interview 12 months after the start of training. 

OutcomesNumber of exclusive breastfeeding days; survival curves.
NotesWe have not included data from this study. Data were not reported in a way in which we could incorporate results into the review. Authors report the number of days not the number of participants for exclusive breastfeeding. It is reported that the median duration of exclusive breastfeeding was 106 days before and 107 days after the intervention period for the control group. For the intervention group the median duration of exclusive breastfeeding was reported to be104 days before and 125 days after the intervention period; the difference was reported to be statistically significant.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskMethod not described; it was reported that half of the women were assigned to the Intervention group and the other half to the control group
Allocation concealment (selection bias)Unclear riskNot described; 20 intervention clinics and 15 control (not clear).
Blinding (performance bias and detection bias)
outcome assessors
High riskClinics assigned to intervention and control (blinding not attempted?).
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNot clear. Authors reported that dropouts were negligible because all children registered were contacted with the help of community health agent.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskData extraction from translation (original paper in Portuguese). Cluster trial with no apparent adjustment for design effect

Chapman 2004

MethodsRCT 2-arm trial. Individual randomisation (n = 219). Recruitment July 2000-August 2002 at an urban US hospital with BFI accreditation.
Participants

Urban US hospital prenatal clinic serving a low-income, predominantly Latina population. Background rates of breastfeeding initiation: Low.

Antenatal inclusion criteria: low-income women at least 18 years old, at 26 weeks' gestation or less, considering breastfeeding, not yet enrolled in peer counselling programme, resident in hospital area, available for telephone follow-up. Postnatal inclusion criteria: healthy, full term singleton infants, no congenital abnormalities, no maternal history of HIV and no admission to NICU. After birth, n = 165 women remained in the study, 90 in the intervention group and 75 controls

Participant characteristics: Ethnic composition 80% Hispanic (61% Puerto Rican origin), 9% African American, 3% white, 8% other.

Interventions

Control: routine breastfeeding education offered by the study hospital, and the same breastfeeding services as privately paying women. A small amount of exposure to peer counsellors among the control group was reported.

Intervention: 1 prenatal home visit, daily visits during postpartum hospitalisation, home visit within 24 hours and at least 2 more home visits as requested, and telephone/pager contact. Intervention from peer counsellors with 30 hours classroom training that covered LLLI Peer Counseling Program and Hispanic Health Council's curriculae. Peer counsellors had to score 85% in a written exam and work for 3-6 months with experienced peer counsellors to demonstrate competence before working independently with clients. Peer counsellors had 1 hour per month continuing education and were paid for their work.

OutcomesBreastfeeding rates at birth and 1, 3 and 6 months postpartum.
Subgroups most responsive to breastfeeding peer counselling.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskBy computer programme.
Allocation concealment (selection bias)Unclear riskNot described.
Blinding (performance bias and detection bias)
outcome assessors
Unclear riskIt was not stated whether there was any attempt to blind outcome assessors.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskLoss to follow-up appeared reasonably balanced although there was more loss from the control group. Reasons for loss to follow-up stated. 219 were randomised, 72% followed up at 1 month, 70% at 3 months and 66% at 6 months.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskGroups appeared similar at baseline. It was reported that many women in the intervention group received less than half of the planned visits.

Chen 1993

MethodsQuasi-randomised trial with sequential allocation to 3 study groups.
Participants180 women (not clear) attending a hospital in Southern Taiwan. Inclusion criteria: breastfeeding at hospital discharge, term, healthy infant, able to read Chinese. (Hospital discharge at approximately 5 days.)
Interventions

Control: usual care.

Phone support intervention: weekly phone calls for 2 weeks after hospital discharge then at 4 and 8 weeks postpartum by maternity nurse. The calls were to increase women’s self confidence.

Home visits intervention: same schedule as phone support group with visits at home by the maternity nurse.

OutcomesBreastfeeding duration and analysis of factors affecting duration of breastfeeding.
NotesWe have not included data from this study in the review as data were not reported in a way that allowed us to enter them into RevMan 2011 for meta-analysis.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High risk

Sequentially to 1 of 3 groups.

 

Allocation concealment (selection bias)High riskIn sequence (could be anticipated and changed by the person carrying out randomisation).
Blinding (performance bias and detection bias)
outcome assessors
Unclear riskNot discussed.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNot clear. 180 women were followed up. It was not clear whether this number was randomised.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskBaseline characteristics of 3 groups similar.

Coutinho 2005

MethodsRCT, 2-arm trial with individual randomisation
Participants

The study was carried out in 2 hospitals serving urban areas and neighbouring small towns in the interior of the State of Pernambuco, north-eastern Brazil. Background rates of breastfeeding initiation: High.

Inclusion criteria: singleton infants. Exclusion criteria: infants with congenital anomalies or serious illness necessitating intensive care and those whose mothers had serious disease or mental illness or were planning to leave the area within 6 months.

Approximately 60% had income lower than the minimum wage; 33% did not have access to a flush toilet, approximately 35% of the mothers were less than 20 years, 39% primiparous, approximately 28% CS.

Interventions

Maternity staff in both hospitals received (90%) the 18h UNICEF/WHO Baby Friendly Hospital Initiative training course. All participants in the intervention and control groups received their hospital postnatal care from these Baby-Friendly trained staff.

In addition, women in the intervention group received ten postnatal home visits (mean duration 30 minutes); 4 during the first month, 2 during the second month and 1 per month during the 3rd to 6th months. Each mother was given an illustrated booklet. At each visit the home visitors observed the positioning of the infant at the breast, flow of milk and the baby’s satisfaction; encouraged exclusive breastfeeding for 6 months and continued breastfeeding for at least 2 years and used the booklet as a basis for discussions of key topics relevant to the infant’s age. If there were any difficulties home visitors could not resolve they referred the mother for more specialist help at the hospital. If other family members were present, their attitude towards exclusive breastfeeding was assessed and their support was sought, including help with household chores.

OutcomesThe main outcome is exclusive breastfeeding. Data collected prospectively at 1, 10, 30, 60, 90, 120,150 and 180 days after birth. Any breastfeeding at same time points. The type of other fluids introduced was also recorded at each time point.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomised in blocks of 10 per town by use of a random numbers table. The random numbers were generated by the project manager, and enrolment and group assignment were made by 2 maternity-based research assistants.
Allocation concealment (selection bias)Unclear riskConcealment was achieved by drawing numbers from envelopes at the time of assignment.
Blinding (performance bias and detection bias)
outcome assessors
High riskData were collected in the trial by 4 researchers who were not aware of group allocation and were unconnected with the delivery of the interventions. Mothers in the trial were not close neighbours, so discussion with other mothers is unlikely, but we did not formally assess whether masking was maintained. For participants they were not blinded and they did not formally assess whether masking was maintained. For those delivering the intervention (caregivers), they would be aware of group assignment. For the outcome assessors, they were described as blinded but not clear if blinding was effective.
Incomplete outcome data (attrition bias)
All outcomes
Low risk350 women were randomised, 175 in each group. 20 women (6%) were lost to follow-up.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear risk

The random numbers were generated by the project manager and so this leads to bias.

Results were presented in graphs and aggregated results were not simple to interpret.

de Oliveira 2006

MethodsRCT (methods not clear) 2 arm trial with individual randomisation.
Participants

From maternity ward of the Hospital de Clinicas de Porto Alegre in Brazil, a university general hospital with Baby Friendly accreditation. Background rates of breastfeeding initiation high, however median duration of exclusive breastfeeding 29 days. Inclusion criteria: mothers living in the city of Porto Alegre, healthy non twin newborns with a birthweight equal or greater than 2500 g. Exclusion criteria: mother-infant pairs that were unable to stay together due to a health concern in either the mother or infant.

Mothers 20 years old or more 76%, vaginal delivery 72%, white mothers 70%, more than 8 years education 64%, living with partner 83%.

Interventions

Control: standard hospital care met Baby-Friendly standards. The control group appear not to have received home visits.

Intervention: In hospital, 2 nurses reinforced the orientation about breastfeeding technique routinely given to mothers, following the WHO breastfeeding counselling principles, in a 30-minute session with no more than 2 mother-infant pairs. Topics included comfortable and proper mother and infant positioning, correct attachment of the child to the breast and manual milk expression. Pictures, dolls and a model breast were used for demonstrating proper breastfeeding technique. The intervention group also received 2 home visits from the same nurse, when the child reached 7 and 30 days of age. Infant feeding patterns, positioning, attachment, milk expression and breastfeeding problems were discussed, and breast examination performed.

OutcomesThe primary outcome is the number of mothers who breastfed and exclusively breastfed on maternity ward and at 30 days. The secondary outcome is the frequency of breastfeeding related problems.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High riskFollowing interviews and feeding assessments, mother-infant pairs were randomly assigned by pulling coloured balls from a bag indicating either the control or experimental group. After the number of mothers calculated for the experimental group were selected, all women eligible for the study were added to the control group until the sample was complete.
Allocation concealment (selection bias)High riskBy drawing coloured balls from bags – this could be changed and it was not clear that all women in the control group were randomly allocated.
Blinding (performance bias and detection bias)
outcome assessors
Unclear riskThe researchers responsible for the breastfeeding evaluations did not participate in the intervention and were blinded to the group to which the mother infant pairs had been assigned”. Not clear if blinding was effective.
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk233 women were eligible, 211 followed up. (It was not clear how many were randomised.)
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear risk

Groups were described as similar at baseline although it appeared that more women in the control group that had had previous breastfeeding experience were more likely to feed for 6 months (65%) compared to women in the intervention group (47.5%).

Unequal numbers in the intervention and control group.

The groups were not balanced (74 in the intervention group and 137 controls). It was not clear that all the women in the control group were randomly allocated.

Dennis 2002

MethodsSingle-site study recruiting over 10 months, n = 258. RCT, 2-arm trial with individual randomisation.
ParticipantsWomen at home in Toronto, Canada. Background rates of breastfeeding initiation: Intermediate. Inclusion criteria: English speaking; primiparous; 16 years or over; single full-term baby. Intending to breastfeed. Predominantly educated, Caucasian and over 25 years with income over $40,000/year.
Baseline prevalence: breastfeeding initiation 79%; 35% exclusive breastfeeding at 4 months.
Interventions

Control: not described

Intervention: telephone support by briefly-trained volunteers (2.5 hour session) who had personal breastfeeding experience for at least 6 months. First contact within 48 hours of hospital discharge and then as required. Mean number of contacts in those completing log-books = 5.4. Mean duration of telephone contact = 16.2 min. 97% of contacts by telephone. 3% at home.

OutcomesBreastfeeding (any or exclusive) at 1, 2 and 3 months.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomly generated numbers were provided by a statistician who was not involved in the recruitment process.
Allocation concealment (selection bias)Low riskConsecutively numbered, sealed opaque envelopes.
Blinding (performance bias and detection bias)
outcome assessors
Unclear risk“A research assistant blinded to group allocation telephoned the participants to collect data regarding current infant feeding status, breast problems encountered and health services used.” Not clear if attempted blinding of outcome assessor was successful.
Incomplete outcome data (attrition bias)
All outcomes
Low riskVery little loss to follow-up. 258 women randomised and 2 women lost to follow-up
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasLow riskNo apparent differences between groups at baseline.

Di Meglio 2010

MethodsRCT, 2 arms with individual randomisation (n = 78).
Participants

Setting: 2 hospitals in Rochester, NY, USA. Background rates of breastfeeding initiation: Low.

Inclusion criteria: Maternal age < 20 years, uncomplicated postpartum, breastfeeding singleton infant born at gestational age > 36 weeks and weight > 2000 g, mothers and infants discharged home together.

Exclusion criteria: maternal contraindications to breastfeeding (HIV, active substance abuse), postpartum transfusion or intensive care; infants in intensive or special care unit > 6 hours, infants with anomalies that interfered with breastfeeding (e.g. cleft lip or palate).

Participant characteristics: Mean age 18.3 years, approximately half were African Americans, approximately one-third had private or health maintenance organisation insurance, the rest were on Medicaid or Medicaid HMO, more than 80% were first time mothers and gave birth vaginally.

Interventions

Usual care included access to paediatric care providers and hospital lactation consultants.The control group did not receive telephone peer support.

Intervention group: telephone support from trained peer supporters (teen mothers who had breastfed for more than 4 weeks). Peer supporters telephoned the new teen mothers at 2, 4, 7 days and 2, 3, 4 and 5 weeks post discharge. Peers introduced themselves and talked about the breastfeeding experience. No specific discussion topics were assigned. Peers offered their telephone numbers so that new mothers could call for support. They were advised to refer anyone with a problem to telephone resources for breastfeeding information or to their physician. Peers and women received gift voucher incentives to complete assessments and training.

OutcomesPrimary outcome: ‘any breastfeeding’ duration, as measured by the age in days at complete breastfeeding cessation. Secondary outcome: exclusive breastfeeding duration, as measured by the time to the first introduction of any other supplement (water, juice, vitamins or formula).
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk

Computer-generated random numbers.

 

Allocation concealment (selection bias)Low risk“The assignment was recorded in a sealed and numbered envelope. Envelopes were sequentially opened.”
Blinding (performance bias and detection bias)
outcome assessors
Unclear risk

Blinding attempted but not clear if it was successful.

Participants: “In order to blind subjects to the study hypothesis, recruiters explained that this study was about: how young mothers who breastfeed in the hospitals feed their babies at home; how young mothers make feeding decisions and who helps them make those decisions.”

Outcome assessor: “a single research assistant conducted all the telephone interviews, using standardised, closed ended questionnaires. The interviewer had no knowledge of the study hypothesis or design.”

Incomplete outcome data (attrition bias)
All outcomes
High risk

78 randomised (38 intervention, 40 control).

In control group- 5 dropouts before first interview; 2 dropouts before 8-week interview; 9 dropouts between 8 and 21 weeks.

In intervention group- 6 dropouts before first interview; 3 dropouts before 8-week interview; 7 dropouts between 8 and 37 weeks.

Overall,  11 women dropped out immediately after recruitment (14%). By 8 weeks 21% lost to follow-up. 46/78 (61%) were successfully followed up to complete breastfeeding cessation (22 intervention and 24 control).

Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear risk

Of  the 5 adolescents who completed peer support training, there was only 1 that remained involved for the entire duration of the study.

There was very poor compliance with possibly only half of the intervention group receiving the planned intervention. The analysis is presented in diagrams that are not simple to interpret.

Study results published in 2010, data collection 1996-7.

Di Napoli 2004

MethodsRCT 2-arm trial. Women randomised. Single-site study. Mothers recruited March 2000-December 2001, n = 605.
ParticipantsUrban Italy. Background rates of breastfeeding initiation: Intermediate. Inclusion criteria: mothers in public maternity ward in Rome, intending to breastfeed. Exclusion criteria: mothers who did not speak Italian, had no phone, breastfeeding medically contraindicated, baby in SCBU. Ethnic composition not defined. Baseline national breastfeeding initiation rate 70%.
Interventions

Control: standard care (not described).

Intervention: home visit and telephone contact. Home visit, from 1 of the 6 midwives from the maternity ward of the study hospital, took place within 7 days of hospital discharge. Telephone breastfeeding counselling session provided by the same midwife. These midwives had attended the UNICEF 18 h intensive training course on breastfeeding techniques and management.

OutcomesAny breastfeeding up to 60 days.
NotesExtra information about reported numbers requested and received from author.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskSample was stratified "for age and parity, and finally randomly assigned to either the intervention or control group".
Allocation concealment (selection bias)Unclear riskNot described.
Blinding (performance bias and detection bias)
outcome assessors
High riskOutcome assessment not blinded.
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk605 women randomised. Full data were available for 278 women (46%) and partial data available for a further 264 (44%). Follow-up rates for breastfeeding outcomes collected up to 180 days but after 60 days follow-up rates were less than 75% so only outcomes up to 60 days are included in this review. Reasons for drop-out reported by group.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskBaseline characteristics similar and no apparent differences between those who refused intervention and those who received it, see Table 1.

Ekstrom 2006

MethodsLongitudinal study. 2 arms. Cluster-randomised trial. 10 Swedish municipalities randomised.
Participants

Setting: Antenatal Centres and Child Health Centres in 10 municipalities in Southwest Sweden. Background rates of breastfeeding initiation: High.

Inclusion criteria: Swedish speaking mothers who gave birth to singleton, healthy term infants spontaneously, by vacuum extraction or by caesarean section.

Participant characteristics: mean age approx 27 years, married 61-69%, vaginal delivery 70-75%, university educated 36%.

Interventions

Control group: offered standard family classes, usually discontinued at birth.

Intervention group: The intervention included continuity of care at the antenatal and child centres, and a process oriented training program of 7 sessions for health professionals. The staff training included reflection on personal experience of breastfeeding and breastfeeding counselling, management and promotion. Staff were encouraged to develop a common breastfeeding policy between the antenatal and child health centres. The family classes were also kept together before and after childbirth.

OutcomesMaternal perceptions of the relationship with the infant, maternal feelings for the infant and duration of exclusive/any breastfeeding.
Notes10 centres randomised. A total of 540 women took part in the study (intervention group 206 women; 2 control groups 162+172 = 334 women). Data collection took place at different times for the 2 control groups. We have included data from 378 women; the intervention group (206 women) and 1 control group (172 women), from which data were collected at the same time as from the intervention group.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskThe 10 largest municipalities were classified in pairs that were similar in size and had similar figures of breastfeeding duration. The municipalities were randomised pair wise to either an intervention or control group.
Allocation concealment (selection bias)Unclear riskDoes not say.
Blinding (performance bias and detection bias)
outcome assessors
High riskDoes not appear to be any blinding.
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk

The sample included women cared for in intervention clinics and then 2 control groups. However, data collection in 1 of the control groups was carried out before the intervention period so in the analyses we have included only the control group were collected simultaneously with the intervention group (total 540 women, 378 included in analysis).

Response rates at 3 days 84% and 93% in the intervention and control groups, by 9 months postpartum 64% and 73%.

There was no adjustment for cluster design.

Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskThere was no baseline imbalance apparent, although duration of exclusive breastfeeding was presented as a baseline characteristic.

Ellis 1984

MethodsStudy design: RCT. 2-arm trial with individual randomisation.
ParticipantsSetting not clear: women expecting to give birth in an urban maternity unit, Canada. 120 women recruited in late pregnancy. 
Interventions

Control: usual care in hospital with assistance from nurses who had received breastfeeding education.

Intervention: In addition to usual care, prenatal breastfeeding class and postnatal drop-in breastfeeding session. Telephone follow-up by nurse at 2, 6 and 12 weeks postpartum. 

OutcomesExclusive breastfeeding at 1 and 3 months and any breastfeeding at 3 and 6 months.
NotesWe have not included data from this study in the review due to high levels of attrition (> 25% loss to follow-up). Recruitment to the study took place during pregnancy and by 1 month postpartum there was high loss to follow-up and loss was not balanced across groups. At 1 month 42% of controls and 22% of the intervention group were not available for follow-up. The high level and unbalanced attrition means that results from this study are difficult to interpret.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot described.
Allocation concealment (selection bias)Unclear riskDescribed as “randomly assigned”.
Blinding (performance bias and detection bias)
outcome assessors
Unclear riskNot discussed.
Incomplete outcome data (attrition bias)
All outcomes
High risk

Recruitment to the study took place during pregnancy and by 1 month postpartum there was high loss to follow-up and loss was not balanced across groups. At 1 month 42% of controls and 22% of the intervention group were not available for follow-up. The high level and unbalanced attrition means that results from this study are difficult to interpret.

 

Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskOther bias: there was very little information on study methods and most of the results in the paper are not reported by randomisation group.

Frank 1987

MethodsSingle-site RCT (n = 343) recruiting over 17 months. (4-arm trial with factorial design).
Participants

Urban USA: in-patient maternity unit. Background rates of breastfeeding initiation: Low.

Inclusion criteria: breastfed once in hospital; able to speak Spanish or English; baby needed less than 48 hours on NICU; able to be contacted by telephone after discharge.

Participant characteristics: 57% primiparous. Ethnic composition: black 65%, Hispanic 19%, white 13%, other 4%. Socio-economic status defined by: < 100% poverty level - 69%; 100%-200% poverty level - 21%; > 200% poverty level - 10%. Mean age of participants 25.7 years.

Interventions

Routine care consisted of postpartum staff nursing contacts (including discharge teaching session on infant care), infrequent breastfeeding classes, written information on breastfeeding management and the opportunity to access a midwife-run telephone advice line.

Intervention:

(1) Postpartum breastfeeding counselling in hospital by trained counsellor (20-40 minutes) and by telephone at 5, 7, 14, 21, 28, days and 6, 8 and 12 weeks. 24 hour advice by pager.
(2) Research discharge pack in English and Spanish.

OutcomesExclusive breastfeeding at 1, 2, 3 and 4 months. Any breastfeeding at 4 months. Median duration of breastfeeding. Time to introduction of formula or solids. Rehospitalisation of infants.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomised block design (block size 8) with computer-generated list of random numbers.
Allocation concealment (selection bias)Low riskSequentially numbered opaque sealed envelopes.
Blinding (performance bias and detection bias)
outcome assessors
Unclear riskFor follow-up at 4 months it was stated that the investigator was not aware of group assignment; however, it was not clear whether outcome assessment blinding was effective (outcome assessment by telephone interview).
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk

Participants received a fee to minimise sample attrition.

343 women were recruited. There were a small number of protocol deviations (7 women received the wrong type of discharge pack and were analysed according to treatment received rather than by randomisation group). 19 women were lost to follow-up. Attrition and reasons for attrition were described as similar across groups. follow-up 94%. Appropriate randomisation procedures.

Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasLow riskNo baseline imbalance apparent.

Froozani 1999

MethodsSingle-site study recruiting over 7 months, n = 134.
ParticipantsUrban Iran. Background rates of breastfeeding initiation: High. Inclusion: Women without breastfeeding experience or chronic disease giving birth normally at term to a healthy baby 2.5 kg or over.
Interventions

Control: standard care not described.

Intervention: nutritionist trained using WHO Breastfeeding Counseling training course (40 hours). Contact in hospital immediately after birth, between 10 and 15 days, after 30 days and monthly to the 4th month at home or in a lactation clinic.

OutcomesExclusive breastfeeding at 1, 2, 3 and 4 months. Mean number of days illness with diarrhoea.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High riskAllocation by day of the week of birth.
Allocation concealment (selection bias)High riskAllocation could be anticipated in advance and different days of the week may have had different characteristics (e.g. staff on duty).
Blinding (performance bias and detection bias)
outcome assessors
High riskWomen were not told directly which group they had been assigned to but would be aware of whether or not they had received the intervention. It was not stated whether or not there was any attempt to blind outcome assessment.
Incomplete outcome data (attrition bias)
All outcomes
Low risk134 randomised and 120 followed up.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasLow riskNo baseline imbalance apparent.

Gagnon 2002

MethodsRCT with individual randomisation. 2-arm trial, n = 586, 292 assigned to intervention group and 294 to control group.
Participants

Study conducted at a University teaching hospital and affiliated community health centres. Recruitment January 1997-September 1998 Urban Quebec, Canada. Background rates of breastfeeding initiation: Intermediate.

Inclusion criteria: mothers participating in hospital short-stay programme. Ethnic and socio-economic composition of sample not reported. Baseline prevalence of breastfeeding initiation in Canada (excluding territories) 1994-5 = 73%.

Interventions

Control: usual care was a 48-hour postpartum contact and 1 postpartum hospital clinic visit (day 3) following a standard plan of care and lasting up to 45 minutes. Referral for continued care was available.

Intervention: Home visit from community nurse 3-4 days postpartum. Nurses were Baccalaureate prepared, had minimum 3 years clinical experience in maternal-child health, and had attended training to ensure assessment skills of maternal-newborn and breastfeeding support. Contact with the nurse continued if required.

OutcomesBreastfeeding frequency and infant weight gain assessed at 2 weeks postpartum.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskBlock randomisation (block size 8) stratified by parity, by computer-generated random numbers.
Allocation concealment (selection bias)Unclear riskNot described.
Blinding (performance bias and detection bias)
outcome assessors
Unclear riskIt was reported that outcome data were collected by blind investigators. It was not clear whether planned blinding was effective, although investigators apparently asked women "not to divulge their group status".
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk586 randomised. 21 protocol deviations but analysis according to randomisation. 499 completed trial and provided information on primary outcome (15% attrition). Some further missing data for some outcomes.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasLow riskGroups described as similar at baseline.

Graffy 2004

MethodsRCT 2-arm trial with individual randomisation. Study conducted in 32 general practices in the UK. Recruitment April 1995-August 1998, n = 720, 363 assigned to intervention group and 357 to control group.
ParticipantsUrban South-East England. Background rates of breastfeeding initiation: Intermediate. Inclusion criteria: mothers considering breastfeeding who had not breastfed a previous child for 6 weeks. Exclusion criteria: planning to contact a breastfeeding counsellor, address considered unsafe to visit, baby born before 36 weeks' gestation. Ethnic composition of sample: 59% white (UK) participants, 11% white (other) participants, 16% African or Caribbean, 8% Indian subcontinent, 6% other. Socio-economic status on RG classification: 10% I, 26% II, 19% IIINM, 26% IIIM, 12% IV, 3% V, 5% other. First baby: 74%. National baseline prevalence 66% breastfeeding at birth.
Interventions

Control: standard care (UK standard care includes postnatal home visits from midwives and health visitors)

Intervention: women were allocated to receive 1 antenatal visit from a National Childbirth Trust trained breastfeeding counsellor, who offered postnatal support by telephone or further visits if the mother requested this after the birth.

OutcomesPrevalence of any breastfeeding to 6 weeks; duration of any breastfeeding to 4 months; time to introduction of formula feeds; maternal satisfaction and common feeding problems; mothers' perspectives on support from counsellors; association between counselling uptake and feeding behaviour.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskPermuted block design stratified by GP practice and parity, randomisation schedule prepared by statistician.
Allocation concealment (selection bias)Low riskNumbered sealed envelopes.
Blinding (performance bias and detection bias)
outcome assessors
Unclear riskReported that responses to follow-up questionnaires were coded by blind assessors.
Incomplete outcome data (attrition bias)
All outcomes
Low risk720 women recruited and randomised. 97% available for follow-up at birth, 93% at 6 weeks and 86% at 4 months.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskGroups were similar at baseline although more women in the intervention group (16) than the control group (6) were undecided about breastfeeding intention at the antenatal assessment. It was reported that a sensitivity analysis was carried out to adjust for this possible confounder.

Gross 1998

MethodsCluster-randomised trial. 4 clinics were “randomly assigned" to 4 different conditions.
Participants

Setting: 4 WIC clinics in Baltimore USA. Women were predominantly African American (>90%).

548 women attending study clinics enrolled at between 6 and 24 weeks’ gestation. Women were WIC eligible with singleton pregnancies, planning to keep the baby and to stay in study areas.

Interventions

The study was carried out in 4 clinics. Each clinic offered a different intervention.

Clinic 1: standard care (usual breastfeeding promotion by clinic staff).

Clinic 2: standard care plus motivational video (encouraging breastfeeding) playing repetitively in the clinic waiting area.

Clinic 3: peer support by a mother who had breastfed and undertaken training. Peer supporters contacted pregnant women and discussed breastfeeding. Women were offered a 1-hour group breastfeeding support session in the WIC clinic before the birth. After the birth peer counsellors contacted women and remained in contact with breastfeeding women (phone or visits) until 16 weeks after the birth.

Clinic 4: standard care plus video plus peer support.

OutcomesInfant feeding method at 8 and 16 weeks postpartum and maternal work status.
Notes

We were not able to include data from this study in the review due to very high levels of attrition. The study was at high risk of bias. This was a cluster trial with 4 clinics each allocated to a different intervention and with no adjustment for study design effect. Women were recruited in the antenatal period

548 women were enrolled on the study but information was only available for 273 women at 7 to 10 days postpartum (50%); of the 275 women lost to follow-up 31% (74) were excluded due to pregnancy complications, the remaining 73% (201 women) refused or could not be contacted – these women represent 37% of the original randomised sample. It was not clear whether loss was similar in the 4 clinics.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskCluster trial. 4 clinics;  method of randomisation not described.
Allocation concealment (selection bias)Unclear risk

Not described.

 

Blinding (performance bias and detection bias)
outcome assessors
Unclear riskNot attempted. Randomisation at clinic level may have reduced contamination.
Incomplete outcome data (attrition bias)
All outcomes
High risk548 women were enrolled on the study but information was only available for 273 women at 7 to 10 days postpartum (50%); of the 275 women lost to follow-up 31% (74) were excluded due to pregnancy complications, the remaining 73% (201 women) refused or could not be contacted – these women represent 37% of the original randomised sample. It was not clear whether  loss was similar in the 4 clinics.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskBaseline characteristics imbalance for educational status, employment and parity - although these were adjusted for in the analysis.

Grossman 1990

MethodsQuasi-RCT, 2-arm trial with individual randomisation. Single-site study recruiting over 10 months, n = 97. Follow-up 90%. Quasi-randomised (coin toss with women sharing same room allocated by the same toss).
Participants

Urban USA - in-patient maternity unit. Background rates of breastfeeding initiation: Low. WIC breastfeeding prevalence at birth 1991 = 33%.

Inclusion criteria: women eligible for WIC programme services for those on low incomes; women intending to breastfeed.

Participant characteristics: Approximately one-third were primiparous. Ethnic composition described as 54% black. Mean age 25.4 years.

Interventions

Control: routine postnatal teaching on infant care and feeding by obstetrical nursing staff.

Intervention package of: face-to-face meeting in hospital with lactation counsellor (a registered nurse) after birth lasting 30-45 minutes - educational booklet given; telephone contacts on days 2, 4, 7, 10 and 21; a telephone help-line staffed by a nurse or paediatrician; back up support for those with problems from a lactation clinic.

OutcomesRates of breastfeeding at 6 weeks and 3 and 6 months. Median duration of breastfeeding.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High riskCoin toss at the point of randomisation.
Allocation concealment (selection bias)High riskCoin toss at the point of randomisation, so allocation could be altered. If 2 women occupied the same room they were allocated to the same group.
Blinding (performance bias and detection bias)
outcome assessors
High riskSome data were derived from medical records but telephone outcome assessment not blinded.
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk97 women randomised, by 6 weeks 4 control group women could not be contacted (> 90% follow-up but loss not balanced across groups).
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskGroups appeared similar at baseline.

Haider 2000

MethodsCommunity-based cluster-randomised study (40 adjacent areas randomised). Recruitment over 10 months, n = 726.
ParticipantsDakka, Bangladesh. Background rates of breastfeeding initiation: High. Mainly lower-middle and low socio-economic status. Women aged 16-35 with 3 children or fewer (or 6 pregnancies or fewer) and no serious illness. Multiple births; children with congenital abnormalities, and those weighing less than 1800 g were excluded. National baseline prevalence reported in paper to be similar to control group rates. UNICEF quotes higher rates - 53% exclusive breastfeeding at 0-3 months.
InterventionsPeer counselling by women with personal breastfeeding experience trained over 40 hours with the WHO/UNICEF Breastfeeding Counseling course. Paid honorarium. Supervised caseload of 12-25 mothers. 15 home visits: 2 in last trimester/4 in month 1/2-weekly in months 2-5. Duration of visits 20-40 minutes.
OutcomesExclusive breastfeeding at birth, 4 days, 4 weeks, 2, 3, 4 and 5 months.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskRandom number tables.
Allocation concealment (selection bias)Unclear riskNot described.
Blinding (performance bias and detection bias)
outcome assessors
High riskWomen and counsellors aware of group assignment and interviewers collecting outcome data would also be aware of assignment.
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk40 areas randomised (20 intervention, 20 control) 726 women randomised. 653 available to follow-up at delivery (90%). 573 available at 5 months (79%). Loss appeared balanced across groups. No ITT analysis.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasLow riskNo differences in baseline characteristics apparent. Staed that results were based on individual level analysis but with adjustment for cluster level of randomisation.

Hall 1978

MethodsStudy design: RCT with 3 arms
Participants49 women giving birth in a small community hospital in the USA planning to breastfeed for at least 6 weeks and breastfeeding for the first time. All women had healthy babies. Women were described as married and middle class aged 17–31.
Interventions

3 groups.

Control: 18 randomised 12 followed up (not clear).

Intervention group 1: 15 randomised 13 followed up (not clear): usual care plus an educational session.

Intervention group 2: 16 randomised 15 followed up (not clear): usual care plus education plus daily visits by nurse while in hospital and telephone support 2 days after discharge and 1 week later and further support if necessary (up to 5 weeks postpartum). 

OutcomesUnclear. Breastfeeding at 6 weeks and breastfeeding problems.
NotesWe have not included data from this study in the review due to methodological weakness and high and unbalanced levels of attrition. More than 30% of the control group were lost to follow-up and results were therefore difficult to interpret. Most results were not reported according to randomisation group and the only result on breastfeeding duration was approximate. “Approximately 50% of the control group and 50% of the group which received the teaching unit were still nursing at six weeks. Of the group who received the teaching plus support 80% were still nursing at 6 weeks.” 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot described.
Allocation concealment (selection bias)Unclear riskDescribed as “randomly assigned”.
Blinding (performance bias and detection bias)
outcome assessors
Unclear riskNo blinding although outcome assessment was not by the same nurse as the 1 delivering the intervention.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskThere was high attrition in this small study. More than 30% of the control group were lost to follow-up and results were therefore difficult to interpret.
Selective reporting (reporting bias)Unclear riskMost results were not reported by randomisation group.
Other biasUnclear riskNo baseline characteristics reported.

Hoddinott 2009

MethodsCluster-RCT with prospective mixed method embedded case studies to evaluate implementation processes; 2 arms. 14 localities randomised; recruitment 2002-4.
Participants

Setting: women registered at GP practices in 14 localities (of 66) in Scotland. Background rates of breastfeeding initiation: Low. In Scotland, only 44% of babies received any breast milk at 6 weeks in 2005.

Clusters randomised n = 14, birth records supplying data n = 9747 in intervention group and n = 9111 in control group. Inclusion criteria: pregnant women and breastfeeding mothers. Exclusion criteria: not stated.

In intervention localities 25.2% of the populations were in the most deprived social groups, compared with 32.1% in the control localities. Mean age of mothers at the first child health record was 28-29 years. In 7 areas (3 intervention, 4 control) women gave birth at Baby-Friendly hospitals.

Interventions

Control: control localities received no additional intervention; however, breastfeeding support groups existed in some control areas.

Intervention: this was a policy intervention aimed at locality areas rather than at individual women. The intervention was a policy aim to double the number of local breastfeeding support groups and to make weekly support groups open to all pregnant women and breastfeeding mothers. The local breastfeeding support groups were to be facilitated by health professionals taking a woman-centred approach and aiming to provide breastfeeding support and social interaction for women. 

Outcomes

Primary outcome: number of babies receiving any breast milk at 6-8 weeks, as reported in routinely collected data for the 2 pre-trial years and 2 trial years.

Secondary outcomes: any breastfeeding at birth, 5-7 days and 8-9 months, and maternal satisfaction.

Results were not presented in a way which allowed us to enter them into data and analysis tables but we have summarised findings in the text.

NotesWhen we updated our search in October 2011, Hoddinott 2009 was the only evaluation we found a) of a policy-level intervention; b) of breastfeeding in groups; c) that used routinely collected locality-level outcome data.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskCluster-RCT; 14 localities randomised. Localities varied in size, baseline breastfeeding rates and numbers of pre-existing groups and how pregnancy and postnatal care were organised. Localities were matched on breastfeeding rates and existing support groups “An independent statistician used random number tables to randomise locality pairs to either intervention or control”. 
Allocation concealment (selection bias)Low riskResearchers analysing primary and secondary outcomes were blind to allocation, ensured by coding of localities.
Blinding (performance bias and detection bias)
outcome assessors
Unclear riskCluster-randomised trial so women may not have been aware of the study although they would be aware of the intervention. Researchers analysing primary and secondary outcomes were reported to be blinded.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskAccording to flow chart no clusters discontinued the intervention or were lost to follow-up and there was follow-up of national data in all localities included in the trial. The amount of data missing for women varied for different outcomes (e.g. birth and 6 week postpartum records were available for most of the eligible population but child health records at 8-9 months available for approximately a quarter of children).
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskAnalysis took into account aspects of design effect. It appeared that there were some differences in the localities at baseline. Control localities may have had higher levels of social deprivation

Hopkinson 2009

MethodsRCT with 2 arms, n = 522 women randomised.
Participants

A large metropolitan hospital in Houston, Texas, USA, serving predominantly immigrant Hispanic women (85% monolingual Hispanic). Background rates of breastfeeding initiation high in this study population. Inclusion criteria: mothers of low-risk infants, mixed feeding in hospitals, had telephones and access to transportation.

Exclusion criteria: Infants with elevated risk for hyperbilirubinaemia (preterm, discharged at < 48 hours old, jaundice within 24 hours of birth, Rh-incompatibility, cephalohematoma, positive Coombs test, family history of disorders of red blood cell enzyme defects, or defects of red blood cell shape and size).

Participant characteristics: Mean maternal age intervention group 26.8, control group 27.1; mean parity intervention group 1.5, control group 1.5; mothers born in the USA intervention group 2.8%, control group 1.1% (most of the women were born in Mexico or Central America).

Interventions

Control group: received usual care, which included bedside breastfeeding assistance before hospital discharge and the phone number of the hospital breastfeeding clinic with instructions to call if needed.

Intervention group: mothers were given an appointment to visit the hospital-based breastfeeding clinic at 3 to 7 days postpartum. At the breastfeeding clinic, peer counselling sessions included a breastfeeding history, breast examination, infant oral-motor assessment, measurement of infant weight, evaluation of latch and milk transfer, and discussion of the mother's concerns and support system. Additional visits and telephone consultations were provided if deemed necessary by the mother and the clinic staff. Women who missed appointments received a telephone call.

OutcomesPrimary outcome: exclusive breastfeeding at 1 month. Secondary outcomes: volume of formula given by mothers who were mixed feeding and incidence of breastfeeding problems.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk

Generated by random number table.

 

Allocation concealment (selection bias)Low riskAfter participants had given informed consent, the group was determined using opaque, sealed envelopes containing assignments generated by random table number. The envelope was opened by the mother.
Blinding (performance bias and detection bias)
outcome assessors
Unclear riskParticipants were not blinded as the envelope was opened by the mother. Caregivers were also not blinded. For outcome assessors, outcomes were determined by telephone survey at 4 weeks postpartum by interviewers blinded to group assignment.
Incomplete outcome data (attrition bias)
All outcomes
Low risk522 randomised (255 in intervention group and 267 in control group. 55 women were lost to follow-up at 4 weeks. (10.5%). Loss was balanced in the 2 groups. Issues around incomplete data were addressed.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasLow riskThere were slight baseline differences between control group and experimental group. Women in the intervention group were more likely to have an emergency caesarean, and were taller. Due to low compliance with the intervention secondary analysis was carried out, but we have reported data from the primary analysis (unadjusted).

Jenner 1988

MethodsQuasi-randomised trial. Recruitment location/duration not stated, n = 38.
ParticipantsUK white, working-class women 19-32 years, living with partner and intending to breastfeed. Background rates of breastfeeding initiation: Intermediate: prevalence of breastfeeding 1985 = 64% at birth and 26% at 4 months.
Interventions

Control: 1 antenatal home visit and 1 postnatal hospital visit.

Intervention: 3 antenatal home visits/1 hospital visit/1 'immediate' home visit and 1 or 2 further home visits 'in the early weeks'; face-to-face and telephone support by single lay supporter (mother/previous breastfeeding experience). No indication of training.

OutcomesBreastfeeding at 3 months. Partial breastfeeding grouped with formula feeding as 'breastfeeding failure'.
NotesModerate-to-high risk of bias.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High riskAlternate.
Allocation concealment (selection bias)High riskAlternate allocation.
Blinding (performance bias and detection bias)
outcome assessors
High riskNot attempted.
Incomplete outcome data (attrition bias)
All outcomes
Low risk38 women included. It appeared that all were followed up.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskVery little information on study methods.

Jones 1985

MethodsQuasi-randomised trial, individual randomisation. Single-site study. Recruitment period 18 months, n = 678.
Participants

UK - maternity department of district general hospital. Background rates of breastfeeding initiation: Intermediate.

Inclusion criteria: all women who attempted at least 1 breastfeed. Exclusion criteria: birth of child overlapped intervention and control periods. 55% of the sample were primiparous. Ethnic composition not stated. Socio-economic status defined by UK census categories (I and II 22%, III 46%, IV and V 13%).

Interventions

Control: not specified.

Intervention: individual support and problem solving by lactation nurse in hospital and at home. Duration of the intervention not specified.

OutcomesBreastfeeding rates at 4 weeks, 3, 6 and 12 months. Satisfaction with care and intention to breastfeed next pregnancy.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High riskAlternating 2 week periods (i.e. 2 week intervention recruitment period, 2 week control recruitment period).
Allocation concealment (selection bias)High riskThe randomisation method did not achieve balanced group size; 228 in the intervention group vs 355 controls.
Blinding (performance bias and detection bias)
outcome assessors
Unclear riskStae that 12 months follow-up was by an independent interviewer.
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk

678 women randomised and 649 available to follow-up (96%)

Potential confounder: Late exclusion of 66 women because of overlap of recruitment periods and group sizes were uneven.

Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskThe method of recruiting intervention and control women appeared different; possibly face-to-face for intervention group and records/ not clear for the control group.

Kaojuri 2009

MethodsNot clear; described as “case control randomized trial”. 2 arms.
Participants

Setting: Tehran, Iran; mothers and babies recruited in a Baby Friendly accredited hospital. The intervention included a programme of home visits. 120 women (baseline characteristics not described).

Inclusion criteria: women giving birth to singletons by caesarean section only.

Exclusion criteria: infants with congenital abnormalities or serious illness necessitating intensive care and mothers who had a serious illness or were planning to leave the area within 6 months. Infants weighing less than 2500 g at birth were also excluded.

Interventions

Intervention: 4 postnatal home visits (not clear)

Control group: standard care (not clear)

Outcomes

Follow-up interviews by telephone on days 90, 120, 150 and 180.

Results were not reported in a way in which we can include them in the review. Authors report that "the patterns of exclusive breastfeeding in the 2 groups for days 3 to 180 differed significantly (P < 0.0001) with a mean aggregated of 67.72% among the group assigned home visits compared with 31.78% for the group assigned none".

NotesWe have not included data from this study in the review. Results were difficult to interpret and data were not reported in a way that allowed us to include them in meta-analyses.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot described.
Allocation concealment (selection bias)Unclear riskNot described.
Blinding (performance bias and detection bias)
outcome assessors
High riskNo blinding of participants/professionals reported.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNot clear. 120 women were recruited but it was not clear how many were followed up.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear risk

Does not state what was included in the telephone interview.

Results reported on exclusive breastfeeding (not reported in a form we can use in the review).

Khresheh 2011

MethodsRCT (n = 140) with 2 groups, Aug 2008-Apr 2009.
ParticipantsRecruitment from postnatal wards of 2 hospitals in South Jordan. Inclusion criteria: primiparous women following vaginal delivery with term infants. Exclusion criteria: women who lived outside the study area or who could not be contacted by phone. Prevalence of "ever breastfed" in country: 93% (WHO Global Data Bank on Breastfeeding, accessed 12 Oct 2011). Paper states that traditionally most women initiate breastfeeding and breastfeed for up to 2 years, with 32% fully breastfeeding for more than 6 months.
Interventions

Usual care: women were given an appointment for 6 weeks after discharge to attend the maternal and child health services for support and follow-up. Paper states most women did not return for these appointments and were not receiving any postnatal care.

Control group women did not receive postnatal home visits from a midwife or a child health nurse.

Intervention group women received a 1-hour education session approximately 2 hours after the birth. The session included demonstrations of breastfeeding. Mothers were encouraged to ask questions and were given a pamphlet on breastfeeding. At 2 and 4 months postpartum women were contacted by phone by the same researcher/nurse. The purpose of calls was to offer support, monitor breastfeeding practices and identify any problems.

OutcomesPrimary outcomes were exclusive breastfeeding at 6 months and breastfeeding knowledge. Secondary outcome was infant hospital admissions for diarrhoea and vomiting or respiratory tract infections.
NotesDue to high levels of attrition (36%) we have not included outcome data from this study in the review.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot described.
Allocation concealment (selection bias)Low riskPaper states randomisation occurred by women selecting 1 envelope from a group of sealed opaque envelopes.
Blinding (performance bias and detection bias)
outcome assessors
High riskNo blinding described and it appears that the same researchers that collected data also carried out recruitment and delivered the intervention.
Incomplete outcome data (attrition bias)
All outcomes
High riskSerious loss to follow-up. At 6 months, follow-up was 62.5% in the intervention group and 66.2% in the control group.
Selective reporting (reporting bias)Unclear riskNot apparent.
Other biasUnclear riskData collection procedures varied at 6 months. Some women were visited at home while others were telephoned. It was not clear how many women in the control and intervention groups were telephoned vs visited. The different data collection procedures may have affected responses.

Kools 2005

MethodsCluster-randomised study with 10 sites, divided into 2 groups, which had similar numbers of births and breastfeeding rates. Recruitment December 2000-December 2002, n = 781, 408 women in sites assigned to the intervention and 373 in sites assigned to the control group.
ParticipantsChild healthcare centres in Limbourg province, Netherlands. Background rates of breastfeeding initiation: High. Inclusion criteria: mothers applying for maternity care at any of the 10 centres. Exclusion criteria: birthweight < 2000 g. Ethnic composition not defined. Baseline prevalence of breastfeeding initiation 80% in the Netherlands in 2002.
Interventions

Control: not specified.

Intervention: programme with 3 elements: structured health counselling by maternity and child healthcare nurses and physicians; booklet to transfer information between caregivers and between mother and caregivers and used at each consultation; lactation consultancy available via caregiver faxing consultant with details of problem (consultant would then contact the caregiver or mother within 24 hours of receiving the fax).

OutcomesExclusive and complementary breastfeeding rates at 3 months; determinants of breastfeeding at 3 months.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskBy coin flip.
Allocation concealment (selection bias)Low riskClusters were randomised after sites were paired for similarity of breastfeeding rates and the number of births in each centre.
Blinding (performance bias and detection bias)
outcome assessors
High riskOucome assessors not reported as blinded.
Incomplete outcome data (attrition bias)
All outcomes
Low risk20 centres were randomised. 781 women. Data available for 701 for the first follow-up (90%) and 683 (87%) at 6 months postpartum.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasLow riskAnalyses adjusted for cluster effect by multi-level analysis. No baseline imbalance apparent.

Kramer 2001

MethodsMulti-site cluster-randomised study. Recruitment period 19 months, n = 17,046.
ParticipantsUrban and rural sites within Belarus. Background rates of breastfeeding initiation: High. Inclusion criteria: intention to breastfeed, healthy mother, child 2500 g or more at term, Apgar 5 or more at 5 minutes. Baseline breastfeeding prevalence 50% at 3 months.
Interventions

Control: staff did not receive the training.

Intervention: WHO/UNICEF BFI training for all staff dealing with mothers and babies in hospitals and community polyclinics. Infants seen monthly for polyclinic well-child visits and whenever ill.

OutcomesAny breastfeeding at 3, 6, 9 and 12 months. Incidence of respiratory, gastro-intestinal and atopic eczema in first year.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskCluster-randomised trial with double randomisation procedure. Random number tables were used to ascribe numbers to sites and higher/lower numbers were used to allocate sites to A or B interventions. Then later, in public, a coin flip was used to determine whether A or B would be intervention or control sites.
Allocation concealment (selection bias)Low risk2-stage randomisation procedure.
Blinding (performance bias and detection bias)
outcome assessors
Unclear riskClinical outcomes were recorded by staff caring for women but an audit was also carried out.
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk34 sites randomised, 2 of which refused to carry out allocated intervention and 1 clinic falsified outcome data and was excluded. 31 sites contributed data. In addition, follow-up data were missing for 3.3% of women.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear risk

A steering group ensured that "control sites did not institute any changes that would render their maternity hospitals or polyclinics more baby friendly".

Analysis took account of cluster design.

Groups appeared similar at baseline.

Kronborg 2007

MethodsCluster-randomised, 2 community based trial. 22 municipalities randomised to intervention and control clusters.
Participants

Western Denmark, urban and agricultural areas. Background rates of breastfeeding initiation: high. The 5 hospitals serving the area had adopted Unicef/ WHO Baby Friendly Hospital Initiative standards, and 3 of the 5 were accredited at the time of the study.

Inclusion criteria: Danish mothers who lived in the 22 municipalities and gave birth to a single child with gestational age of 37 completed weeks or more.

Participant characteristics: 36% primiparous, 7.5% multiparous with previous short breastfeeding experience

Interventions

Usual care included hospital care at hospitals working to Baby-Friendly standards, and an existing Health Visitor service in all municipalities.

Control cluster: Health Visitors' usual practice consisting of 1 or more non-standardised visits.

Intervention cluster: 1 to 3 structured home visits within the first 5 postnatal weeks from Health Visitors with additional training. Main topics for the first visit were effective breastfeeding technique and learning to know the baby; for the second visit, self-regulated feeding and interpretation of the baby's cues; for the third visit, sufficient milk and interaction with the baby. Mothers were also given a booklet about how to breastfeed and how to read the baby's cues.

OutcomesDuration of exclusive breastfeeding and mother’s satisfaction with breastfeeding
NotesThe authors did not adjust for cluster design effect. In our data and analysis tables we have adjusted the sample size and event rates to take account of the design effect. We calculated an effective sample size by dividing figures by the design effect – calculated using the ICC for breastfeeding cessation given in the paper: ICC = 0.02.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskTo ensure that the health visitors that were in regular contact with each other were randomised to the same breastfeeding procedure the 22 municipalities were chosen as clusters. The 22 clusters were stratified according to their number of births the year before the trial, and within 3 strata, 11 municipalities were randomised to the intervention group and 11 to the comparison group. The randomisation was computerised and done independently of the investigators.
Allocation concealment (selection bias)Low riskAs for the sequence generation.
Blinding (performance bias and detection bias)
outcome assessors
Unclear riskParticipants and caregivers were not blinded. Outcome assessors were blinded- the identity of the health visitors was blinded to the investigators. It was not clear whether this partial blinding was effective.
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk22 municipalities were randomised. 2186 women had babies during the study time period. 1760 women followed up (figure showing trial attrition not printed out with paper – to check).
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear risk

Reported that there were no significant differences between groups at baseline.

This was a cluster-randomised trial and authors state they did not make allowance for clustering in the sample size calculation as the cluster effect was expected to be small. Elsewhere in the paper an ICC value is provided which the authors say indicate that cluster effect was small. It was not clear that cluster design effect was taken into account in any of the analyses.

Labarere 2005

MethodsRCT, 2 arms with individual randomisation. Recruitment: October 2001 to May 2002.
Participants

Setting: the maternity section at the Chambery Teaching hospital in Chambery, France. Background rates of breastfeeding initiation: Intermediate. In the study hospital, breastfeeding prevalence rates were 70.8% in hospital and 58.1% at 1 month of infant age.

Participants randomised = 231.

Inclusion criteria: mothers of healthy singleton infants (gestational age: > 37 completed weeks), breastfeeding on the day of discharge and consented to participate in the study.

Exclusion criteria: infants admitted to neonatal unit, mothers transferred to intensive care unit, mothers <18 years old, living outside the area, unable to speak French, or unable to complete follow-up monitoring because of psychosocial problems such as homelessness.

Participant characteristics: age, mean, SD: intervention: 29.3 (4.1); control: 29.7 (4.8); education more than high school graduate: intervention: 87 (75.0); control 84 (73.0); white collar worker: intervention: 92 (79.3); control 87 (75.6); primiparous: intervention: 58 (50.0); control: 63 (54.8).

Interventions

Control group (n = 115) standard care: mothers received verbal encouragement from maternity ward staff to maintain breastfeeding. On discharge, the infant was examined by the paediatrician working in the department, for a general health assessment and an evaluation for evidence of successful breastfeeding behaviour. The mothers were also provided with the telephone number of a peer support group that they could call to ask questions and request help. The post discharge follow-up monitoring consisted of routine, preventive, outpatient visits in a primary care physician’s office at 1, 2, 3, 4, 5 and 6 months of infant age.

Intervention group (n = 116): in addition to standard care, mothers were invited to an outpatient visit in a primary care physician’s office within 2 weeks after the birth to see a primary care doctor who had received special breastfeeding education. Topics covered at this visit included general health assessment, lactation physiology, feeding position and latch on assessment, management of common lactation problems (nipple pain, nipple cracks, sore nipples, mastitis, and maternal concern regarding low milk supply), management of infant problems (insufficient weight gain, breastfeeding jaundice, diarrhoea and dehydration), maternal medication use while breastfeeding and sources of support. The physicians' training programme was delivered through lectures, panel discussions, role playing exercises and printed educational materials.

OutcomesThe primary outcome was exclusive breastfeeding at 4 weeks. Exclusive breastfeeding was defined as giving maternal milk as the only food source, with no other liquids or foods. The secondary outcomes were any breastfeeding at 4 weeks, median duration of breastfeeding, breastfeeding difficulties and maternal satisfaction with the infant feeding experience.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskThe allocation sequence was generated by the statistical adviser of the study with random permuted blocks with a block size of 8.
Allocation concealment (selection bias)Low riskThe randomisation assignments were unknown to any of the investigators and were concealed in consecutively numbered, sealed, opaque envelopes.
Blinding (performance bias and detection bias)
outcome assessors
High riskNo blinding. The trial was described as open, although questionnaires to mothers were used to reduce the risk of observer bias, and reduce outcome assessment bias.
Incomplete outcome data (attrition bias)
All outcomes
Low risk(1080 women assessed for eligibility, 849 deemed not eligible). 231 women randomised, outcome data were available for all but 5 of the woman randomised, and a sensitivity analysis was carried out where the most conservative values were assumed for those women lost to follow-up.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskThe majority of women assessed were not eligible for inclusion in this trial and so the results may not be generalisable.

Leite 2005

MethodsParticipants recruited from 8 public health maternity units. Duration of recruitment 6 months, n = 1003. RCT 2-arm trial with individual randomisation.
ParticipantsUrban Brazil. Background rates of breastfeeding initiation: High. Inclusion criteria: healthy babies, weighing < 3000 g. Exclusion criteria: twins, important health problems in mother or child.
InterventionsPeer counsellor home visits lasting 30-40 minutes at 5, 15, 30, 60, 90 and 120 days. Counsellors from same social group as women they supported, had personal experience of breastfeeding and had been associated with maternity unit milk bank for a minimum of 5 years. Trained with adapted WHO breastfeeding counselling course (20 hours). Paid $4 per visit. Each counsellor supported 25 mothers.
OutcomesRates of exclusive, predominant, partial and artificial feeding at 4 months.
NotesThis is the only study in this review that targeted babies with birthweight below 3000 g. We considered excluding it from this review as the paper does not state the babies had to be born at term and does not specify a lower limit for birthweight. However as the babies had to be "free of important health problems" we considered them to be healthy and therefore included this study.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer-generated random number table.
Allocation concealment (selection bias)Low riskStudy secretary opened a sealed envelope that contained the study code.
Blinding (performance bias and detection bias)
outcome assessors
Unclear riskInterviewers collecting outcome data had had no previous contact with the women and were described as being unaware of the objectives of the research. It was not clear if blinding was effective.
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk1003 women randomised. 14% lost to follow-up by the end of 4 months. Reasons for loss to follow-up were not described but the loss appeared balanced across the 2 groups.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasLow riskNo baseline imbalance apparent.

Lynch 1986

MethodsRCT 2-arm trial with individual randomisation Single site study. Duration of recruitment not stated, n = 270.
ParticipantsUrban Canada - maternity unit of regional general hospital. Background rates of breastfeeding initiation: Intermediate. Baseline prevalence (1984) = 69% breastfeeding initiation (75% stopping by 6 months). Inclusion criteria: intending to breastfeed; English speaking. Exclusion criteria: multiple births; birthweight < 2500 g; birth before 37 weeks. 41% were primiparous. Ethnic composition not described. Socio-economic status defined by Blishen scale for husband's occupation (62% groups 2-3).
Interventions

Control: postpartum home visit by public health nurse who gave breastfeeding advice determined largely by the questions and concerns of the mother.

Intervention: combination of home visit by breastfeeding consultant within 5 days of hospital discharge (duration 2 hours) and telephone calls by the consultant weekly for 1 month and monthly from 2-6 months.

OutcomesDuration of breastfeeding.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot described "we randomly allocated 270 new mothers".
Allocation concealment (selection bias)Unclear riskNot described.
Blinding (performance bias and detection bias)
outcome assessors
Unclear riskIt was stated that the interviewer collecting outcome data was not aware of group allocation.
Incomplete outcome data (attrition bias)
All outcomes
Low riskThere appeared to be little loss to follow-up. 270 women were randomised and questionnaire data from 256 (5% attrition). 3 women were lost from the intervention group vs 11 controls.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskLittle information on methods. Possible confounders: significant differences in baseline characteristics were present for parity (P = 0.02) and intention to return to work (P = 0.05).

McDonald 2010

MethodsRandomised controlled trial with 2 groups. Recruitment March 2000-October 2001.
ParticipantsLarge University teaching hospital in Victoria, Australia. Background rates of breastfeeding initiation: High. Participants were women intending to breastfeed their term infants, stratified by tertiary education and parity. Baseline prevalence of breastfeeding in Australia = 83% at hospital discharge.
Interventions

Control: Standard Midwifery Support (SMS) n = 424. Received routine midwifery support and information as per the hospital protocol. The study hospital was working towards Baby-Friendly accreditation during data collection (achieved in 2004).

Intervention: Extended Midwifery Support (EMS) n = 425. Received an in-hospital postnatal education session. Post-discharge, they were offered home support visits with a research midwife once per week and telephone contact at least twice per week for 6 weeks.

OutcomesAny breastfeeding and exclusive breastfeeding at 6 months.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskSample stratified by educational level and parity. Methods not clear.
Allocation concealment (selection bias)Unclear riskPaper states "Women were asked to select an envelope from a group of at least six sealed, opaque envelopes, replenished in blocks of 12. The envelopes contained the allocation to either the intervention or control group".
Blinding (performance bias and detection bias)
outcome assessors
High riskNot mentioned.
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk849 women randomised. Loss to follow-up was reported by group at 2 months (intervention 83/425, 19.5% vs control 124/424, 29.2%) and at 6 months (intervention 8/425, 1.9% vs. control 4/424, 0.9%).
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskAbstract does not include details of allocation concealment, outcome assessment or loss to follow-up. Outcomes included in the abstract are reported by ITT.

McKeever 2002

MethodsRCT with 2 arms, individual randomisation.
Participants

Setting: study carried out in Canada.101 women randomised.

Inclusion criteria: live, singleton, term or near term infant delivered in 12 hours before recruitment. Women aged at least 21 residing in defined study area, intending to breastfeed and had satisfactory home circumstances (assessed by postpartum nurses).

Exclusions: non-English speaking women, caesarean delivery, postpartum complications, infants with congenital abnormalities or morbidity.

Interventions

Control: planned hospital discharge 48-60 hours postpartum (usual care) with hospital based support for breastfeeding.

Intervention: planned early discharge from hospital (24-36 hours postpartum) and up to 3 home visits by community nurse lactation consultants. Content of support unclear.

The study aimed to compare of breastfeeding support in home and hospital settings.

OutcomesExclusive breastfeeding at 5-10 days postpartum and satisfaction with care.
NotesWe have not included data from this study in the review. Outcomes were not assessed at the same time in intervention and control groups (mean day of follow-up was 8.4 days in the intervention group vs 7.8 days for controls) and there was high attrition (26% overall, with 33% loss to follow-up in the control group).
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskCentral randomisation.
Allocation concealment (selection bias)Low riskCentral randomisation by staff not concerned with the study.
Blinding (performance bias and detection bias)
outcome assessors
Unclear riskInterviewers were reported to be initially blinded but this was not sustained as mothers revealed allocation.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskOutcomes were not assessed at the same time in both groups and there was high attrition (26% overall, with 33% loss to follow-up in the control group).
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear risk"At baseline, no differences in maternal age, parity or gestational age were found in the two groups."

McQueen 2011

MethodsPilot RCT (n = 150), March-July 2008.
Participants

Recruitment from 1 hospital in Northwestern Ontario, Canada, the sole provider of maternity care for the city and regional referral centre. Background rates of breastfeeding initiation for Canada: Intermediate, however, baseline prevalence of "ever breastfed" in Ontario 90.6% (WHO Global Data Bank on Infant and Young Child Feeding accessed 12 Oct 2011).

Inclusion criteria: English speaking, primiparous, planning on breastfeeding single, healthy, term infants. Exclusion criteria: conditions that could significantly interfere with breastfeeding such as serious illness, infant with congenital anomaly or admitted to special care.

Interventions

Control: standard in-hospital and community postpartum care, which included a visit by a public health nurse after hospital discharge.

Intervention: standard in-hospital and community postpartum care plus a 1-to-1 self-efficacy intervention from the researcher (a Registered Nurse with practice, education, and research experience working with breastfeeding mothers). The intervention included assessment of the mother’s breastfeeding goals and breastfeeding self-efficacy and her general physiologic and affective state; strategies to increase breastfeeding self-efficacy; evaluation, and planning the next session. There were 3 contacts, 2 face-to-face in hospital on days 1 and 2 after the birth, and 1 phone call up to 7 days after hospital discharge.

OutcomesFeasibility, compliance, and acceptability of the intervention. Breastfeeding confidence (self-efficacy scores), any and exclusive breastfeeding at 4 and 8 weeks.
NotesPaper states "Observation of breastfeeding at 1 of the 2 in-hospital sessions was planned, to try to maximise performance accomplishment (successful breastfeeding)”.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskGroup allocations generated by an experienced researcher not involved in the trial.
Allocation concealment (selection bias)Low riskConsecutively numbered, sealed opaque envelopes.
Blinding (performance bias and detection bias)
outcome assessors
Unclear risk

Participants and caregiver: not blinded (due to nature of the intervention).

Outcome assessor: outcomes at 4 and 8 weeks postpartum were collected during phone interview by research assistant reported to be blind to group allocation.

Incomplete outcome data (attrition bias)
All outcomes
Low riskOutcomes measured at 8 weeks in 134/150  (89%). Loss to follow-up was balanced across groups. For breastfeeding outcomes we have carried out an ITT analysis.
Selective reporting (reporting bias)Unclear riskNo baseline differences between groups apparent.
Other biasUnclear riskBaseline characteristics were similar.

Mongeon 1995

MethodsSingle-site study. Duration of recruitment not stated, n = 200. Follow-up 97%. Quasi-randomised trial (drawing numbered tickets).
ParticipantsUrban Canada. Background rates of breastfeeding initiation: Intermediate. Antenatal meetings in a community health district. Inclusion criteria: women who wish to breastfeed and who have not previously breastfed. 97% of subjects were primiparous. Ethnic composition not stated. 57% had received education to college or university level. No specific socio-economic classification used.
InterventionsHome visit by volunteer during last month of pregnancy followed by telephone contacts weekly for 6 weeks and then 2 weekly to 5 months or until weaning. Volunteers were women who had breastfed themselves and had received 3 training sessions of 3 hours duration followed by on-going monthly supervision sessions. Average caseload 1-3 cases at any one time.
OutcomesBreastfeeding rates at 1, 2, 3, 4 and 6 months.
NotesControl group received home visit from public health nurse during the first month after birth followed by other contacts (face-to-face or by telephone) as determined by the mother.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskRandomisation by "drawing numbered papers".
Allocation concealment (selection bias)Unclear riskNot clear.
Blinding (performance bias and detection bias)
outcome assessors
Unclear riskThere was an attempt to blind outcome assessors.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskReasons for drop-out recorded. 200 randomise, 3 babies died and 3 other women lost to follow-up.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskNot clear over what time period women were recruited or whether controls and intervention women were recruited at the same time. "Subjects were recruited during various periods of time, depending on the availability of volunteers".

Morrell 2000

MethodsRCT. 2-arm trial, individual randomisation.Single-site study recruiting over 14 months, n = 632.
ParticipantsUrban UK. Background rates of breastfeeding initiation: Intermediate. National baseline prevalence 66% breastfeeding at birth and 42% at 4 months. Exclusive breastfeeding 21% at 4 months. All English-speaking women 17 years or over giving birth at the study hospital unless their baby spent more than 48 hours on the SCBU.
Interventions

Control: standard UK care (includes postnatal home visits from midwives and health visitors).

Intervention: community postnatal support worker. 8 week training. Home-based support of up to 10 visits in the first 28 days. Maximum 3 hours per visit.

OutcomesExclusive or any breastfeeding at 6 weeks and 6 months.
Notes

Study population not limited to those intending to breastfeed.

Women consenting to participation more likely to be white and have had a CS.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandom number tables
Allocation concealment (selection bias)Low riskSequentially numbered sealed opaque envelopes.
Blinding (performance bias and detection bias)
outcome assessors
High riskNot stated whether there was any attempt to blind outcome assessors.
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk623 women randomised. Stated that analysis was by ITT; 30 women who declined visits were included in the analysis. 78% follow-up.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskThere was some baseline imbalance between groups. Women in the intervention group were more likely to have twins (9 vs 1), to have another adult resident in their household and to have used TENS in labour.

Morrow 1999

MethodsCommunity-based cluster-randomised study. Recruitment over 18 months, n = 130.
ParticipantsPeri-urban Mexican community. Background rates of breastfeeding initiation: High. All pregnant or postnatal women in 39 geographical clusters. Perinatal death only clinical exclusion criterion. Baseline breastfeeding prevalence: 92% initiation; 4% exclusivity at 2 weeks and 3 months; 50% cessation by 6 months.
Interventions

Control: not specified.

Intervention: home visits by peer-counsellors trained by La Leche League.
(7 days theoretical teaching/2 months in lactation clinics and with mother to mother support groups.) Personal breastfeeding experience not essential. 2 intervention groups 1. 6 visits (mid and late pregnancy and 1, 2, 4 and 8 weeks) 2. 3 visits (late pregnancy and 1 and 2 weeks). 30% secondary education.

OutcomesBreastfeeding at 3 and 6 months. Incidence of diarrhoea in infants 0-3 months.
NotesSubgroup analysis: antenatal and postpartum support; proactive intervention with scheduled contacts at home; initial face-to-face contact; intervention delivered by trained counsellors.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskCluster-randomisation. Clusters stratified by area. Randomisation schedule generated by computer.
Allocation concealment (selection bias)Low riskClusters randomised by computer.
Blinding (performance bias and detection bias)
outcome assessors
High riskClusters randomised to avoid contamination but women and counsellors would be aware of intervention; outcome measurement was by staff who were aware of group allocation.
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk130 women from 31 cluster areas randomised. 125 remaining to follow-up at 3 months and 104 at 6 months (20% attrition at 6 months).
Selective reporting (reporting bias)Unclear riskThe way that cluster design was taken into account was not clear. It was stated that ICC values were "negligible" and "these results show that the cluster-randomisation design achieved the equivalent of individual randomisation".
Other biasUnclear riskNo baseline imbalance apparent although group size was uneven (this may have been due to chance).

Muirhead 2006

MethodsRCT with 2 arms. Individual randomisation (n = 225).
Participants

Setting: General practice in Ayrshire, Scotland. Background rates of breastfeeding initiation: Low.
Inclusion criteria: women at 28 weeks' gestation attending for antenatal care at a GP practice.
Exclusion criteria: not described.

Participant characteristics: mean age of intervention group: 28.5 years; SD 5.2; range 17-43. Mean age of control group: 27.8 years; SD 5.5; range 16-40. Parity: 53% primiparous.

Interventions

Control group (n = 113): standard care, including visits from community midwife for the first 10 days, health visitor after 10 days, breastfeeding support groups and breastfeeding workshops available.

Intervention group (n = 112): women were assigned 2 peer supporters (women with previous breastfeeding experience) who contacted them at least once in the antenatal period and provided further antenatal support on request. In the postnatal period after hospital discharge peer supporters contacted women who were still breastfeeding at least every 2 days by phone or by home visit up until 28 days, and further support was available up to 16 weeks postpartum.

OutcomesInitiation of breastfeeding, any and exclusive breastfeeding at 6 weeks and 6 months, median breastfeeding duration and reasons for giving up breastfeeding.
NotesThe researchers note that "health professionals varied in their commitment to breastfeeding and also in their acceptance of lay assistance, such as peer support".
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskAllocation sequences for each stratum (primagravidae, previous formula feeding, previously breastfed < 6 weeks, previously breastfed > 6 weeks) were generated at the start of the trial by computer in blocks of 10 (that is, 5 random allocations to each of the peer support and control groups in each different block of 10) to give approximate numerical balance between groups.
Allocation concealment (selection bias)Low riskAllocation to control or peer support group was by post-recruitment concealed allocation. Telephone call for the next allocation on the list
Blinding (performance bias and detection bias)
outcome assessors
High risk

"There was no post-allocation concealment as once a woman was allocated to the peer support or control group this was known to the peer supporters and others associated with the trial.”

It was stated that the trial team were not involved in outcome assessment.

Incomplete outcome data (attrition bias)
All outcomes
Low risk

Low loss to follow-up.

Peer support group (intervention group) (112): followed up for 16 weeks, n = 110.

Control group (113): followed up for 16 weeks, n = 110.

Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear risk

Planned recruitment was for 320 women but ended after 225 women recruited, therefore the study had reduced power to detect differences between groups.

Little demographic data were reported so it was not clear whether or not there was baseline imbalance although recruitment was balanced for parity by stratification.

Petrova 2009

MethodsRCT, 2 arms with individual randomisation (n = 104).
Participants

Setting: maternal and paediatric clinic for low-income inner city population (New Jersey, USA).

Background rates of breastfeeding initiation in this population: High.

Inclusion criteria: WIC program-qualified pregnant women in the third trimester of a singleton pregnancy without HIV, cancer, or illegal drug use.

Participant characteristics: 87.5% of the women were of Hispanic origin, 89% spoke Spanish at home, 30% were single, approximately 70% were educated at less than high school level. 37% of the intervention group, compared with 42% of controls, were expecting their first child.

Interventions

Control group (n = 52): routine breastfeeding education and support during the pregnancy and postpartum. Lactation consultant services were available for all postpartum women if any breastfeeding problems arose during the hospital stay.

Intervention group (n = 52): in addition to routine care, allocated to 2 individual educational/support sessions with a lactation consultant in the third trimester of pregnancy lasting 15-20 minutes. After birth the lactation consultant provided support at the hospital or by phone soon after discharge, with further phone support after the first or second week then after 1 and 2 months. The participants were asked to contact the lactation consultant if they experienced any breastfeeding problems.

OutcomesExclusive and any breastfeeding at 7 days and 1, 2  and 3 months postpartum.
NotesAmong multiparous participants, 27/29 (93%) in the intervention group had previously breastfed, compared with 17/25 (68%) in the control group.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk“ We used computer generated random numbers to assign women to the control and intervention groups. Each random number was related to an ordinal number that was assigned to the woman once she assigned the informed consent."
Allocation concealment (selection bias)Unclear riskNot described.
Blinding (performance bias and detection bias)
outcome assessors
High riskNot described.
Incomplete outcome data (attrition bias)
All outcomes
High risk

104 women randomised. 82% available to follow-up at 1 month follow-up (data included in the review) 70% of women followed up for 3 months. (35 out of 52 in intervention group completed the 3-month follow-up (loss of 17). 38 out of 52 in the control group completed the 3-month follow-up (loss of 14).

 

High attrition but reasons for loss given and balanced across groups (e.g. phone disconnected; women did not answer phone; some women did not notify the research team about their delivery.)

Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskThere was some baseline imbalance between groups that means that differences between groups are difficult to interpret. Of the multiparous women 93% in the intervention group had previous breastfeeding experience compared with 68% in the control group. More women in the control group had CS (40% vs 14%).  Both of these differences possibly relate to breastfeeding outcomes.

Porteous 2000

MethodsRCT, 2-arm trial with individual randomisation. Single-site study recruiting over 3 months, n = 52.
Participants

Urban Canada. Background rates of breastfeeding initiation: Intermediate. Baseline breastfeeding prevalence at 4 months: approximately 33%.

Inclusion criteria: singleton pregnancy, healthy mother and child, vaginal delivery, self-identified on breastfeeding questionnaire as unsupported.

Interventions

Control: hospital care may have been from any member of the mother-child nursing team.

Intervention: breastfeeding support from the researcher, a community midwife, consisting of daily visits in hospital, telephone call within 72 hours of discharge and weekly through the 4th week postpartum, and at least 1 home visit (in the first week), with further home visits as required. Home visits lasted 60-90 minutes.

OutcomesExclusive and partial breastfeeding at 4 weeks.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputerised block randomisation procedure (stratified by planned length of breastfeeding, parity and education).
Allocation concealment (selection bias)Unclear riskNot described.
Blinding (performance bias and detection bias)
outcome assessors
High riskThe intervention was provided by the investigator so outcome assessment not blinded.
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk52 randomised, 51 appeared to complete the study. Follow-up 98%.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskRecruitment limited by availability of investigator. No baseline imbalance apparent.

Pugh 1998

MethodsRCT, 2-arm trial with individual randomisation.
Participants

Women were recruited at a US community hospital and had diverse socio-economic status. Background rates of breastfeeding initiation: Intermediate.

Inclusion: women who had experienced vaginal deliveries after full-term pregnancies.

Exclusion: not stated.

Mean age: 24.4 years; married, n = 47 (78%); White n = 55 (93%); completed high school, n = 58 (97%); income of $20,000 or less: n = 13 (22%).

Interventions

Standard care included routine breastfeeding support in hospital following delivery.

Control group: home visit on day 3 or 4 by a hospital nurse (the visit was not specifically about breastfeeding).

Intervention group: 2 home visits by a professional community health nurse and phone call from a qualified lactation consultant. The professional nurse provided a structured teaching and support protocol. The focus of the first visit was to enhance breastfeeding. For the second visit, of up to 2 hours duration, mothers could choose the content from options including help with dishes or laundry. Most chose education or infant assessment; 2 asked for child care help so they could rest and/or spend time with a partner.

OutcomesPrimary outcome: duration of breastfeeding. Secondary outcomes: fatigue, symptoms of anxiety and depression.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskParticipants were randomly assigned to the treatment (n = 30) or control group (n = 30).
Allocation concealment (selection bias)Unclear riskNo information.
Blinding (performance bias and detection bias)
outcome assessors
High riskParticipants and caregivers were not blinded. For outcome assessors, outcome data were collected by a research assistant (by telephone). It was not clear whether blinding was achieved.
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk

Not clear. Loss to follow-up was not mentioned and denominators were not provided for the results.

 

Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskLittle information was provided on study methods. No information on how many women were followed up, blinding, how randomisation occurred.

Pugh 2002

MethodsSingle-site study. 2-arm RCT. Recruitment April 1999-February 2000, n = 41; 21 assigned to intervention and 20 to control group.
Participants

Community intervention in urban USA. Background rates of breastfeeding initiation: Low.

Inclusion criteria: low-income women receiving financial medical assistance. Exclusion criteria not stated. Ethnic composition: 95.2% African American.

Interventions

Control: usual breastfeeding support consisted of support from hospital nurses, assistance by means of a telephone "warm line" and if mothers gave birth on a weekday, 1 hospital visit from a lactation consultant.

Intervention: breastfeeding support visits by community health nurse/peer counsellor team. Support offered daily when in hospital, and at home during weeks 1, 2 and 4 and at the team's discretion. Telephone support from peer counsellor twice weekly through week 8 and monthly through month 6.

OutcomesDuration of breastfeeding to 6 months; healthcare services use by infants; costs.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskDescribed as "assigned randomly".
Allocation concealment (selection bias)Low riskDescribed as "a sealed envelope technique".
Blinding (performance bias and detection bias)
outcome assessors
High riskOutcome assessment by person or by phone; not blinded.
Incomplete outcome data (attrition bias)
All outcomes
Low risk41 women randomised, all appeared to have been followed up.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasLow riskGroups similar at baseline.

Pugh 2007

MethodsRCT, 2-arm trial with individual randomisation (n = 328).
Participants

Setting: 2 hospitals (1 university and 1 community hospital) serving urban areas in Baltimore, Maryland, USA. Background rates of breastfeeding initiation: Intermediate.

Inclusion criteria: mother English speaking, with phone access and living within 25 miles of the hospital, intending to breastfeed, family eligible for WIC program. Singleton term infant (> 37 weeks’ gestation)

Exclusion criteria: Infants or mothers with positive drug screen, infants with craniofacial abnormalities, infants admitted to NICU.

Participant characteristics: All enrolled in WIC program; mean age  23.1 years; 87% African Americans; 26.5% with less than high school education; 79.6% single; 17.4% not employed or in school; 26.6% caesarean births; 50.6% first time mothers; 32.3% with previous breastfeeding experience;

Interventions

Control group (n = 160): usual care included access to a lactation consultant in hospital and phone access after discharge home.

Intervention group (n = 168): In addition to usual care, a structured programme of education and support. This comprised postnatal visits by a breastfeeding team (community nurse and peer counsellor) daily in hospital, 2 home visits in the first week after discharge, a third visit at approximately 4 weeks, then scheduled phone calls by the peer counsellor at least fortnightly until 24 weeks and phone access to the community nurse (24 hr) for 24 weeks. Home visits lasted approximately 45-60 minutes and the average length of phone calls was approximately 20 minutes.

OutcomesAny breastfeeding (breastfed at least once during the previous 24 hours) at 6, 12, and 24 weeks postpartum.
NotesBaseline variables were measured using established valid instruments and were used as co-variates to adjust for differences between randomisation groups in some of the analyses in the paper. In our analyses we have reported unadjusted figures.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer-generated randomisation sequence. Block randomisation (block size 10).
Allocation concealment (selection bias)Low risk“sealed envelope technique” ... not entirely clear, not described in detail but probably adequate.
Blinding (performance bias and detection bias)
outcome assessors
High risk

Baseline data were collected before randomisation therefore this was collected in a blind fashion, however following randomisation women and staff would be aware of group assignment.

There was a serious risk of bias associated with the lack of blinding of outcome assessors. In the intervention group outcome data were collected by the staff carrying out the intervention whereas in the control group outcome data were collected by a research interviewer who the women will not have met.

Incomplete outcome data (attrition bias)
All outcomes
Low risk

70% of those approached randomised.

328 randomised and followed up, 29% lost to follow-up by 24 weeks but all women included in the analyses. Women who withdrew from the study early in the project were assumed not to be breastfeeding and those who were lost subsequently were assumed not to be breastfeeding since their last contact. Both I and C groups were treated in the same way and loss was similar in the 2 groups. The numbers recorded as still breastfeeding therefore represent a conservative estimate.

Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskThere was no apparent baseline imbalance although baseline characteristics were used in regression analysis to determine adjusted treatment effect. In our results we have reported the unadjusted data.

Quinlivan 2003

MethodsRCT. 2-arm trial. Single-site study. Recruitment July 1998-December 2000, n = 136.
Participants

Urban Australia. Background rates of breastfeeding initiation: High. Participants were recruited at a teenage pregnancy clinic serving mostly disadvantaged young women. The intervention was offered regardless of feeding intention or practice.

Inclusion criteria: teenagers aged less than 18 years attending first antenatal appointment at public-care teenage pregnancy clinic for first time mothers; English speaking; intending to continue with the pregnancy and not relinquish the infant.

Exclusion criteria: residence > 150 km from the study hospital; known fetal abnormality. Ethnic composition of sample: 24% indigenous Australian. Socio-economic status: 86.5% of sample scored low or destitute on score derived from educational level of participant and her parents, and family income. Baseline prevalence of breastfeeding in Australia = 83% at hospital discharge.

Interventions

Control: routine postnatal support, counselling and information services provided by the hospital included access to routine hospital domiciliary home-visiting services.

Intervention: structured home visits in weeks 1 and 2 by certified nurse-midwives to teach feeding and maternal-infant bonding skills. Further visits at months 1, 2, 3 and 4 to provide advice and support.

OutcomesAdverse neonatal outcomes (infant death, severe non-accidental injury and non-voluntary foster care); knowledge and practice of contraception, vaccination schedules and breastfeeding.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskBy computer-generated randomised allocation schedule.
Allocation concealment (selection bias)Low riskConcealed in numbered, sealed opaque envelopes.
Blinding (performance bias and detection bias)
outcome assessors
High riskWomen, staff and outcome assessors all aware of intervention group.
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk65 assigned to the intervention and 71 to the control group. Reasons for drop-out recorded. 124 completed trial (91%).
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskIt was not clear how the intervention related to some of the outcomes (e.g. early infant death). No baseline imbalance apparent with similar numbers of women in the 2 groups initiating breastfeeding.

Ransjo-Arvidson 1998

MethodsQuasi-RCT. 2-arm trial.
Participants

Setting: study in a hospital in Zambia. Recruitment between 1989-1992.

408 women recruited 1 hour following delivery at the study hospital.

Inclusion criteria: normal birth, term, singleton, Apgar score > 7 at 1 min, no visible malformation and mother and baby assessed as healthy.

Interventions

Control (n = 200): home visit by a midwife at 42 days only.

Intervention (n = 208): home visits by a midwife at 3, 7, 28 and 42 days.

Home visits lasted about 1 hour. Midwives examined women and infants and asked about their health; any health problems and related actions; breastfeeding patterns; social support (if any). If indicated, midwives referred women for medical help.

OutcomesMaternal and infant health problems.
NotesWe have not included data from this study in the review as data were not reported in a way that allowed us to enter them in to RevMan 2011 for meta-analysis. Numbers of breastfeeding women were not reported by randomisation group.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk2-stage randomisation process with recruitment on certain days, when women were randomly selected to be randomised to treatment groups.
Allocation concealment (selection bias)Unclear riskIt was not clear whether the person carrying out the randomisation had any control over the sample selection and the randomisation process.
Blinding (performance bias and detection bias)
outcome assessors
Unclear riskSome outcome data were collected by staff blind to group allocation.
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk

Patients seen at follow-up for Group A - 98.5% at day 3, 97.5% at day 7, 87% at day 28 and 89% at day 42.

Patients seen at follow-up for Group B - 87% at day 42.

Loss to follow-less than 20% at each follow-up visit.

Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskBaseline characteristics similar.

Redman 1995

MethodsRCT with 2 arms.
Participants

Setting: 235 eligible and consenting women booked for delivery at an Australian hospital in 1989.

Inclusion criteria: primiparous women who expressed a wish to breastfeed, who booked for delivery before 20 weeks’ gestation, aged between 18 and 35 and lived within 20 km of the  hospital.

Women who received care in addition from independent midwives were excluded. 

Interventions

Control: usual breastfeeding care and advice along with routine antenatal classes.

Intervention: programme of care based on health belief model and cognitive-behavioural principles, including a 3-hour group teaching session in the antenatal period and a visit by a lactation consultant shortly after hospital birth, phone support 2-3 weeks later and at 3 months, with a home visit if needed. The lactation consultant was available to provide telephone support at other times.

OutcomesBreastfeeding at 6 weeks and 4 months post delivery and reasons for stopping breastfeeding. Satisfaction with the intervention.
NotesWe have not included data from this study in the review due to very high attrition rates which means results are difficult to interpret. In this study women were recruited in the antenatal period. 235 women were randomised; 30% were lost to follow-up by 6 weeks postpartum (and full interview data were available for only 56% of the sample).  
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High riskAlternate. Odd or even numbered consent forms. It was stated that forms were given out sequentially.
Allocation concealment (selection bias)Unclear riskOdd or evenly numbered consent forms. It was stated that those carrying out recruitment and women were not aware of the code for allocation.
Blinding (performance bias and detection bias)
outcome assessors
High riskNot blinded.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskHigh loss to follow-up with interview data at 6 weeks for only 56% of the sample randomised.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskBaseline characteristics similar - no significant differences between control and intervention groups on any of these variables.

Santiago 2003

MethodsSingle-site study. Recruitment: August 2000-July 2002, n = 101; RCT 3-arm trial with individual randomisation.
ParticipantsUrban setting in Minas Gerais, Brazil. Background rates of breastfeeding initiation: High. Inclusion criteria: mother breastfeeding her well, term baby when appointment for paediatric clinic made; first clinic consultation took place, at 30 days or less. Exclusion criteria: mothers who expressed a preference to see a particular paediatrician; babies no longer breastfed at the first appointment. Ethnic composition: 62% of babies white. Baseline prevalence of breastfeeding in Brazil in the first 30 days = 88%.
Interventions

Control group: babies were monitored by a paediatrician who did not have formal training to promote exclusive breastfeeding.

Intervention group 1: babies were monitored by a paediatrician working with a multidisciplinary breastfeeding team. The paediatrician and team had all received training to promote exclusive breastfeeding (PNIAM: Programa de Incentivo ao Aleitamento Materno, Brazil).

Intervention group 2: babies were monitored by the same paediatrician, in individual consultations.

OutcomesExclusive breastfeeding to 4 months.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk(Risk of bias assessment from translation notes.) Random assignment by drawing lots.
Allocation concealment (selection bias)Unclear riskRandom assignment by drawing lots. Described as simple randomisation in translation notes.
Blinding (performance bias and detection bias)
outcome assessors
High riskIt was stated that staff were aware of group assignment.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskIt was not clear at what time randomisation took place or the number randomised to each group "the exclusion percentages were similar in the three groups". 190 were eligible and 101 completed the study.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskNo baseline imbalance apparent. It was not clear how many women were randomised.

Serafino-Cross 1992

MethodsRCT, 2 arms with individual randomisation (n = 52).
Participants

Volunteers attending prenatal clinics in Massachusetts USA who intended to breastfeed their babies for 2 months or longer (recruitment 1986-1987). Background rates of breastfeeding initiation: Low.

Inclusion: Breastfeeding for the first time, or unsuccessful previous attempts. English speaking. All women received prenatal breastfeeding information.

Interventions

Control group: usual care. Women were given contact details for the clinic nutritionist if problems arose.

Interventions group: home visits and telephone contacts up to 2 months postpartum from an experienced breastfeeding counsellor (who also recruited women to the study). Women received 5-8 visits lasting 30-60 minutes.

OutcomesBreastfeeding at 2 months postpartum and 6 months postpartum.
NotesOnly 1 result was reported that we were able to include in the review: numbers breastfeeding (any) at 8 weeks postpartum 61.% of 26 in the intervention group and 34.6% of 26 in the control group. The remaining data were in a graph and are not easy to interpret or data were not reported by randomisation group.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot described.
Allocation concealment (selection bias)Unclear riskMethod not described “randomised the clients”.
Blinding (performance bias and detection bias)
outcome assessors
High risk

No blinding.

 

Incomplete outcome data (attrition bias)
All outcomes
High risk52 women were recruited. It appeared that all women were followed up at 8 weeks postpartum but that approximately half of  the comparison group were lost to follow-up by 6 months. We have not included any data in the review relating to the outcomes measured at 6 months.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskVery low recruitment rate “it took 14 months to enrol just 52 participants from 4 clinics serving in total approximately 1000 pregnant women per year”. Results may not be generalisable.

Sinclair 2007

MethodsSingle-centre, single blind trial. RCT, 2 arms. Recruitment 2005-2006.
Participants

Setting: maternity unit in Northern Ireland with Baby-Friendly accreditation. Background rates of breastfeeding initiation: Intermediate. One-fifth of women reported to stop breastfeeding before hospital discharge.

Participants randomised n = 182.
Inclusion criteria: primigravid women attending for antenatal care when 20 weeks pregnant, intending to give birth at the study hospital and consented to participate

Exclusion criteria: Women < 20 years old who had commenced the ‘young mums’ parentcraft programme prior to the 20 weeks visit. Vulnerable women, e.g. women who neither spoke nor understood English. Mothers separated from their babies, for example when a baby was admitted to the neonatal unit, who did not receive routine instruction (post-randomisation exclusion).

Sample characteristics for n = 144 who completed the research (not reported by randomised group)

Age 21-30 years 79/144 (55%); 31-40 years 53/144 (37%)

SES 38 (26%) professionals; 20 (14%) not working 

Interventions

Standard care at the study hospital, received by all study participants, met Baby-Friendly standards and complied with National Institute for Clinical Excellence (NICE) guidelines. Women in the control group (n = 89) received a 2-hour antenatal infant feeding class, a breastfeeding book and midwife support for the first 3 postnatal weeks.

The intervention was staff training. Women in the intervention group (n = 93) received a “motivationally enhanced” version of control group care from staff who had been trained in a programme called ‘Designer Breastfeeding’.

Outcomes

Primary outcome: using 7-point Likert scales women’s motivational profile was measured in relation to 3 motivational factors: total value placed on breastfeeding, perceived midwife support and expectancy for successful breastfeeding.

Secondary outcomes: breastfeeding behaviour was measured as a secondary outcome on discharge from hospital and at 3 weeks postnatal. Breastfeeding initiation was defined according to the Department of Health as giving 1 breastfeed or 1 episode of expressed breastmilk. Duration of breastfeeding was categorised in accordance with the Index of Breastfeeding Status, which classified breastfeeding on a scale in accordance with the amount of breast milk the infant is receiving.

NotesOnly 53 of the 89 women randomised to the control group were known to have initiated breastfeeding. In the intervention group 57 of 93 randomised initiated breastfeeding.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk"Prior to recruitment a randomised table was created."
Allocation concealment (selection bias)Low riskThe authors state: "Neither the researcher, nor the research participants could predict their allocated treatment".
Blinding (performance bias and detection bias)
outcome assessors
Unclear riskDescribed as single blind. Women were said to be not aware of groups, but there were stickers on the notes so care providers would be aware of group assignment.
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk234 assessed for eligibility, 182 consented and 144 completed.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskThere were some baseline differences between groups. Women in the control group were more likely to be discharged from hospital early and were less likely to attend antenatal infant feeding classes. It is not clear what impact these differences had on the results.

Sjolin 1979

MethodsSingle-site quasi-randomised trial (n = 146). Duration 12 months.
Participants

Urban Sweden - maternity ward of University Hospital. Background rates of breastfeeding initiation: High.

Inclusion criteria: resident in Uppsala; normal birth; healthy babies weighing > 3 kg. Ethnic composition not stated. 28% of mothers had completed college or university education. Baseline prevalence (1972): 4% breastfeeding at 24 weeks.

Interventions'Interview' with paediatrician in hospital on days 1 and 4 and at home at 2 and 6 weeks and 3 months; telephone contact weekly while breastfeeding followed by home visit if problem noted.
OutcomesPartial and exclusive breastfeeding at 2, 4, 8, 12, 16, 20 and 24 weeks.
NotesPrimarily designed as a study of the reasons for breastfeeding difficulties and the cessation of breastfeeding. Recruitment halted during holidays.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High riskQuasi-randomisation depending on time of day of birth.
Allocation concealment (selection bias)High riskQuasi-randomisation.
Blinding (performance bias and detection bias)
outcome assessors
High riskWomen in the control group were not told about the study until the 6 months follow-up interview. All interviews were carried out by the same investigator who was aware of group allocation.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInterviews took place while women continued to breastfeed and it was not clear how many women remained to follow-up at different points although no drop-out was reported for the final data collection interview at 6 months.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskWomen in the intervention group reported outcomes at scheduled interviews whereas the control group were interviewed at 6 months postpartum only. Recall and response bias may have been different in the 2 groups.

Su 2007

MethodsRCT, 3-arm trial with individual randomisation (n = 450).
Participants

National University Hospital, Singapore. Background rates of breastfeeding initiation: High.

Inclusion criteria: healthy pregnant women attending antenatal clinics at the study hospital, with no illness that would contraindicate breastfeeding or severely compromise its success; intending to breastfeed; birth at 34 weeks gestation or later.

Exclusion criteria: women with high risk and multiple pregnancies.

Participant characteristics: 40% primiparous, mixed ethnicity (Chinese 31-44%, Malay 46-54%, Indian and other), approximately a third educated beyond secondary school, approximately half employed outside the home, 56% had previously breastfed.

Interventions

Control: women received routine antenatal, intrapartum and postnatal care, including optional antenatal classes and postnatal visits by a lactation consultant should any problems with breastfeeding arise.

Intervention 1 - Antenatal education: in addition to routine care, women received 1 session of antenatal breastfeeding education and printed guides on breastfeeding.

Intervention 2 - Postnatal lactation support: in addition to routine care, women received two postnatal sessions with a lactation consultant, 1 in hospital within the first 3 postnatal days (when they received the same printed guides on breastfeeding as the antenatal education group) and 1 during the first routine postnatal visit 1 to 2 weeks after the birth. Each session lasted about 30 minutes and covered latching on, proper positioning and other techniques to avoid common breastfeeding complications.

OutcomesExclusive and any breastfeeding at hospital discharge and 2 weeks, 6 weeks, 3 and 6 months after the birth. Exclusive breastfeeding was defined as giving breast milk as the only food source, with no other foods or liquids, other than vitamins and minerals being given.
NotesThe group receiving the antenatal intervention are not included in the analysis in this review.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer-generated randomisation sequence by external clinical trials unit.
Allocation concealment (selection bias)Low riskTelephone allocation by external trials unit (with envelope back up used only on 4 occasions)
Blinding (performance bias and detection bias)
outcome assessors
Unclear riskData collection was on standard forms and was entered by remote unit, therefore outcome assessment may have been partially blinded. For participants, blinding was not mentioned, but women would be aware of allocation. For caregivers, those who delivered the intervention, would be aware of the intervention. For outcome assessors, this was not clear but may have been partially blinded.
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk

Low attrition in all arms. In total 450 randomised 347 completed follow-up at 6 months (82%). In the data and analyses 2 arms included 299 randomised, 245 followed up at 6 months (82%).

 

Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear risk

There was an imbalance in the groups due to 4 women being randomised by using back up envelopes because of dysfunction in web randomisation, but groups appeared similar at baseline.

Some of the data were based on assumptions. Sensitivity analyses were based on the assumption that none of the women lost to follow-up were exclusively breastfeeding at any time point.

Tylleskar 2011a

MethodsOne of the 3 country sites that completed the cluster-randomised trial - Burkino Faso in French speaking West Africa (24 clusters, 12 intervention, 12 control). Mother-infant pairs enrolled: 392 intervention and 402 control (794 total). Followed up at 24 weeks: 359/392 (92%) intervention and 372/402 (93%) control.
Participants

Rural area. Main source of income farming. 60 primary care facilities and a regional hospital. Mean age of women 25 years. None of the women had any formal education and more than half had a previous child death. 99% of women had none or open toilets and < 1% had piped water in yard or home. Monthly income was approximately 3 euros. Baseline prevalence of breastfeeding initiation: High (98.4%). Exclusive BF for babies under 6 months estimated at 16%.

Inclusion Criteria: Women living in trial area at least 7 months pregnant and intending to breastfeed. Singleton live birth, no serious congenital malformations.

Exclusion Criteria: If mothers or infants died they were not included in the analysis

Interventions

Control: Mothers and infants in control clusters in Burkina Faso were given standard healthcare only. 76% of pregnant women attend antenatal care and 51% of deliveries were assisted by trained staff. Under 5 mortality rate 169/1000 live births and infant mortality 92/1000 live births. In Burkina Faso, only the peer counsellors were supporting mothers for exclusive breastfeeding.

Intervention: Peer counselling. Supporters received a modified version of WHO/UNICEF training (1 week training). Women were given information about breastfeeding and peers provided support and addressed problems or referred women for specialist help. The intervention involved a minimum of 5 home visits 1 in the third trimester and at least 4 in the postnatal period up to 6 months postpartum. The supporters were local residents, literate, able to travel to visit women in their homes and to have a good reputation in the community. Peer counsellors visited the same women each time to achieve continuity of care. The intervention varied in the 3 study areas and was adapted to local circumstances.

OutcomesPrevalence of exclusive breastfeeding and prevalence of diarrhoea, reported by mothers for infants aged 12 weeks and 24 weeks.
NotesThe paper states that current breastfeeding was assessed at all scheduled postpartum visits using past 24-hour and 7-day recalls. Babies reported to have received no other food or liquids other than breast milk (they may have been administered drugs) were classified as exclusively breastfed. This may have been during the last 24 hours/7 days rather than since birth. Prevalence of diarrhoea was based on the mothers’ reports of the past 2 weeks.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskUnclear (different procedures in different areas and procedure in 1 of the 4 areas was not clear) .
Allocation concealment (selection bias)Unclear riskThere was no allocation concealment within clusters and participants would be aware of assignment.
Blinding (performance bias and detection bias)
outcome assessors
High riskThere was no participant or staff blinding. There was an attempt to mask/ blind outcome assessors to randomisation group although it is possible women would have revealed whether or not they received support. The success of attempted blinding was not formally evaluated.
Incomplete outcome data (attrition bias)
All outcomes
Low riskThere was flooding in 1 of the 4 original study area and no results are reported for this area. For the remaining 82 clusters in 3 countries for primary outcomes the authors carried out an ITT analysis (i.e. those that were missing were recorded as non-events, i.e. NOT exclusive breastfeeding and no diarrhoea). 2579 women enrolled. Missing data and missed visits at various data collection points.
Selective reporting (reporting bias)Unclear riskNot apparent.
Other biasUnclear risk

Recruitment procedures and intervention delivery was slightly different in each of the study countries which meant that results were difficult to interpret. It was reported that the ICC in each country for primary outcomes varied considerably and therefore results were reported separately for each country.

 

Authors state “The community-based approach could possibly have resulted in socially desirable answers, and the results were based on self-reports. A bias towards desirable answers and thereby an increased effect size cannot be ruled out. We also noted some questionnaire fatigue in the Ugandan site—i.e., reluctance to fully engage in answering similar questions after a few interviews".

Tylleskar 2011b

MethodsSecond of 3 country sites that completed the cluster-randomised trial - Mbale district in Eastern Uganda (24 clusters, 12 intervention, 12 control). Mother-infant pairs enrolled: 396 intervention and 369 control (765 total). Followed up at 24 weeks: 368/396 (93%) intervention and 329/369 (89%) control.
Participants

Urban and rural areas. Urban area included “large slum migrant settlements”. HIV prevalence for fertile women was 6.2%. 26% of women none or open toilets and 5% had piped water in yard or home. Mean age 25. Women had approximately 6 years of  formal education and approximately a third had a previous child death.  Monthly income was approximately 12 euros monthly. Background rates of breastfeeding initiation: High (> 95%).

Inclusion Criteria: Women living in trial area at least 7 months pregnant and intending to breastfeed. Singleton live birth, no serious congenital malformations.

Exclusion Criteria: If mothers or infants died they were not included in the analysis

Interventions

Control: Mothers and infants in control clusters in Uganda were given standard healthcare only. In 2006, 95% of pregnant women attended antenatal care and 41% delivered in a healthcare facility. The under 5 mortality rate was 135/1000 live births and the infant mortality rate was 85/1000 live births in 2008. In Uganda, only the peer counsellors were supporting mothers for exclusive breastfeeding.

Peer counselling intervention. As in Burkina Faso. Paper states the intervention varied in the 3 study areas and was adapted to local circumstances.

OutcomesPrevalence of exclusive breastfeeding and prevalence of diarrhoea, reported by mothers for infants aged 12 weeks and 24 weeks.
NotesThe paper states that current breastfeeding was assessed at all scheduled postpartum visits using past 24-hour and 7-day recalls. Babies reported to have received no other food or liquids other than breast milk (they may have been administered drugs) were classified as exclusively breastfed. This may have been during the last 24 hours/ 7 days rather than since birth. Prevalence of diarrhoea was based on the mothers’ reports of the past 2 weeks.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskUnclear (different procedures in different areas and procedure in 1 of the 4 areas was not clear) .
Allocation concealment (selection bias)Unclear riskThere was no allocation concealment within clusters and participants would be aware of assignment.
Blinding (performance bias and detection bias)
outcome assessors
High riskThere was no participant or staff blinding. There was an attempt to mask/blind outcome assessors to randomisation group although it is possible women would have revealed whether or not they received support. The success of attempted blinding was not formally evaluated.
Incomplete outcome data (attrition bias)
All outcomes
Low riskThere was flooding in 1 of the 4 original study area and no results are reported for this area. For the remaining 82 clusters in 3 countries for primary outcomes the authors carried out an ITT analysis (i.e. those that were missing were recorded as non-events, i.e. NOT exclusive breastfeeding and no diarrhoea). 2579 women enrolled. Missing data and missed visits at various data collection points.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear risk

Recruitment procedures and intervention delivery was slightly different in each of the study countries which meant that results were difficult to interpret. It was reported that the ICC in each country for primary outcomes varied considerably and therefore results were reported separately for each country.

 

Authors state “The community-based approach could possibly have resulted in socially desirable answers, and the results were based on self-reports. A bias towards desirable answers and thereby an increased effect size cannot be ruled out. We also noted some questionnaire fatigue in the Ugandan site—i.e., reluctance to fully engage in answering similar questions after a few interviews".

Tylleskar 2011c

MethodsThird of 3 country sites that completed the cluster-randomised trial - 3 geographically separate sites in South Africa (Paarl, a town at the centre of a farming district near Cape Town; Umlazi, a large periurban township near Durban; and Rietvlei, one of the country's poorest rural districts). 34 clusters, 17 intervention, 17 control. Mother-infant pairs enrolled: 535 intervention and 485 control (1020 total). Followed up at 24 weeks: 461/535 (86%) intervention and 410/485 (85%) control.
Participants

South Africa (3 areas including 1 of the poorest rural area in South Africa). Under 5 mortality rate in South Africa 67/1000 and IMR 48/1000. Background rates of breastfeeding initiation: High (> 95%). Exclusive breastfeeding at 6 months was estimated at 8% in 2005-9. 16% of women had none or open toilets and 66% had piped water in yard or home. Mean age 23 years. Women had approximately 10 years of  formal education and approximately 7% had a previous child death.  Monthly income was approximately 103 euros.

Inclusion Criteria: Women living in trial area at least 7 months pregnant and intending to breastfeed. Singleton live birth, no serious congenital malformations.

Exclusion Criteria: If mothers or infants died they were not included in the analysis

Interventions

Control: In South Africa, antenatal attendance 94% and hospital delivery rates 84%. Control clusters were visited by peer counsellors, with the same schedule as the intervention clusters, but who assisted families in obtaining birth certificates and social welfare grants. The peer counsellors for the intervention and control clusters in South Africa were kept separate during the study.

Peer counselling intervention: as in Burkina Faso and Uganda. Paper states the intervention varied in the 3 study areas and was adapted to local circumstances.

OutcomesPrevalence of exclusive breastfeeding and prevalence of diarrhoea, reported by mothers for infants aged 12 weeks and 24 weeks.
NotesThe paper states that current breastfeeding was assessed at all scheduled postpartum visits using past 24-hour and 7-day recalls. Babies reported to have received no other food or liquids other than breast milk (they may have been administered drugs) were classified as exclusively breastfed. This may have been during the last 24 hours/ 7 days rather than since birth. Prevalence of diarrhoea was based on the mothers’ reports of the past 2 weeks.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskUnclear (different procedures in different areas and procedure in 1 of the 4 areas was not clear) .
Allocation concealment (selection bias)Unclear riskThere was no allocation concealment within clusters and participants would be aware of assignment.
Blinding (performance bias and detection bias)
outcome assessors
High riskThere was no participant or staff blinding. There was an attempt to mask/blind outcome assessors to randomisation group although it is possible women would have revealed whether or not they received support. The success of attempted blinding was not formally evaluated.
Incomplete outcome data (attrition bias)
All outcomes
Low riskThere was flooding in 1 of the 4 original study area and no results are reported for this area. For the remaining 82 clusters in 3 countries for primary outcomes the authors carried out an ITT analysis (i.e. those that were missing were recorded as non-events, i.e. NOT exclusive breastfeeding and no diarrhoea). 2579 women enrolled. Missing data and missed visits at various data collection points.
Selective reporting (reporting bias)Unclear riskNot apparent.
Other biasUnclear risk

Recruitment procedures and intervention delivery was slightly different in each of the study countries which meant that results were difficult to interpret. It was reported that the ICC in each country for primary outcomes varied considerably and therefore results were reported separately for each country.

 

Authors state “The community-based approach could possibly have resulted in socially desirable answers, and the results were based on self-reports. A bias towards desirable answers and thereby an increased effect size cannot be ruled out. We also noted some questionnaire fatigue in the Ugandan site—i.e., reluctance to fully engage in answering similar questions after a few interviews".

Vitolo 2005

MethodsRCT 2 arms with individual randomisation (n = 500).
Participants

Setting: urban, a low-income area of the city of Sa˜o Leopoldo, Rio Grande do Sul, Brazil. Recruitment from maternity wards of the city's only publicly funded hospital, which mainly serves the low-income population.

Background rates of breastfeeding initiation: High.

Inclusion: low-income mothers with healthy, singleton, full-term (> 37 week) babies with birthweight > 2500 g. 

Exclusion: impediments to breast-feeding, HIV/AIDS, or congenital malformation.

Demographics: 57% male children; 60% of intervention and 52% of control mothers had less than 8 years schooling; 73% of intervention and 67% of controls had low annual incomes (less than US $3000); 34% of mothers were not in paid work; 70% of children were living with mother and father; almost half of the mothers were overweight.

Interventions

Both groups received routine assistance from paediatricians in the health service.

Control (n = 300): standard care (not described).

Intervention (n = 200): dietary advice about breastfeeding and the adequate introduction of complementary foods, given monthly to 6 months in home visits starting within 10 days of the child’s birth then at 8, 10, and 12 months by 12 trained field-workers (undergraduate students in groups of 2) who counselled mothers on the Ten Steps for Healthy Feeding Children from Birth to Two Years of Age (Brazilian Ministry of Health).

OutcomesExclusive breastfeeding at 4 and 6 months; any breastfeeding at 12 months; also diarrhoea, respiratory problems, dental caries, anaemia, hospitalisation and nutritional status at 12-16 months.
NotesAlthough the paper called this intervention dietary counselling, we have included it as a breastfeeding support intervention because its main purpose was to promote exclusive breastfeeding for 6 months followed by healthy complementary foods, and it involved regular visits during the first year of life.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskBlock randomisation in groups of 5.
Allocation concealment (selection bias)Low riskRandomisation was conducted by an investigator not involved in the eligibility and entry of participants into the study. Fieldworkers were informed of this allocation and then proceeded with the study.
Blinding (performance bias and detection bias)
outcome assessors
Unclear risk

Women and care staff would be aware of group assignment. It was stated that fieldworkers collecting outcome data in interviews at 12-16 months were not aware of group assignment.

The impact of lack of blinding is unclear.

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk500 women were randomised (200 to the intervention and 300 to the control group). By 12 months 163 intervention group (81%) and 234 control group (78%) remained available to follow-up. Reasons for loss to follow-up were give by group with reasons. However there were some discrepancies between publications and information provided by the author in the numbers followed up.
Selective reporting (reporting bias)Low riskNot apparent.
Other biasUnclear riskMethod of randomisation led to imbalanced groups. Mothers and children appeared similar at baseline. There were some discrepancies between publications and information provided by the author in the numbers followed up and in the results. We have used information provided by the author.

Wambach 2009

MethodsRCT 3-arm trial with individual randomisation (n = 390).
Participants

The study was carried out in 7 prenatal clinics in the American Midwest. Clinics provided services to low-income adolescent mothers. Baseline prevalence of breastfeeding initiation in country/setting: low.

Inclusion criteria: Age 15-18 years, in 2nd trimester of pregnancy, expecting first birth, planning to keep baby, able to read and speak English, with access to phone.

Exclusion criteria: at birth, only mothers of singleton, term healthy babies were included. Women who had birth complications that prohibited or delayed breastfeeding beyond 48hrs were also excluded.

Sample characteristics: mean age 17 years (SD 0.9); 61% African Americans; 75% low-income; 74% single and living with their families and 71% in school.

Interventions

Intervention (n = 128): 2 antenatal classes (1.5–2 hours) on benefits of breastfeeding and practical issues run by the lactation consultant and the peer counsellor, followed up by phone calls. After the birth, phone calls to those who had initiated breastfeeding, at 4, 7, 11, 18 days and 4 weeks to provide support.

Control (group 1, n = 128): the same contact schedule of classes and phone calls as the intervention group, with content concentrating on more general pregnancy and health issues.

Control (group 2, n = 134): usual care with no special intervention. 

OutcomesData on breastfeeding were available for women who initiated breastfeeding – this means results were difficult to interpret.
NotesWe have not included outcome data from this study in the review due to very high levels of attrition. This was a study where women were recruited in the second trimester and interventions took place both prenatally and postnatally. For postnatal outcomes only those women who initiated breastfeeding were followed up. There was considerable loss to follow-up. 390 were randomly assigned. Women who did not attend at least 1 of the study classes were dropped from the study. Follow-up data on duration of breastfeeding were available for 201 women who initiated breastfeeding (51%).
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk“list of random codes  generated by the study bio-statistician."
Allocation concealment (selection bias)Unclear riskIt was not clear how allocation was concealed at the point of randomisation.
Blinding (performance bias and detection bias)
outcome assessors
Unclear riskNot discussed.
Incomplete outcome data (attrition bias)
All outcomes
High risk390 women were randomised and those not attend at least 1 of the study classes were excluded. Follow-up data on duration of breastfeeding was available for 201 who initiated breastfeeding (51%).
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskUnclear - data limited - only reported in the form of an abstract.

Winterburn 2003

MethodsSingle-site study. Duration of recruitment not reported, n = 72, 30 allocated to the intervention and 42 to the control group.
ParticipantsCommunity study in North Trent, England, UK. Background rates of breastfeeding initiation: Intermediate. National baseline prevalence 66% breastfeeding at birth. Inclusion criteria: mothers attending for antenatal care on 1 area. Other details not reported.
InterventionsThe midwife asked mothers during their pregnancy to identify a close female confidante who could support them to breastfeed, and visited the mother and confidante together during the third trimester to discuss breastfeeding.
OutcomesDuration of breastfeeding to 3 months; women's satisfaction with the intervention; midwives' assessments of the intervention.
NotesNumerical outcome data provided by the researcher.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk"randomly allocated".
Allocation concealment (selection bias)Unclear riskNot described.
Blinding (performance bias and detection bias)
outcome assessors
High riskNot mentioned.
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk72 randomised. It was not clear whether full data were available for all women at 3 months.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskNo baseline characteristics.

Wolfberg 2004

MethodsRCT, 2 arms with individual randomisation. Few details of study methods reported.
ParticipantsPartners of women attending for antenatal care at  Baltimore hospital USA 2001-2. (567 pregnant women were approached).
Interventions

Intervention: 1 group session for fathers, lasting 2 hours, to encourage them to support their partners to breastfeed.

Control: usual care. Fathers in the control group received classes on child safety and baby care.

OutcomesBreastfeeding at 4, 6 and 8 weeks and breastfeeding duration.
NotesWe have not included data from this study in the review due to very high levels of attrition. 567 pregnant women approached, of the 431 that agreed to participate only 59 fathers completed the study (14%). It was not clear at what point randomisation occurred.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot described.
Allocation concealment (selection bias)Unclear riskNot described.
Blinding (performance bias and detection bias)
outcome assessors
Unclear riskControl group received alternative intervention.
Incomplete outcome data (attrition bias)
All outcomes
High risk431 women agreed to participate but only 14% were followed up.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear risk

"The expectant mothers and fathers who were assigned randomly to the 2 study groups were demographically similar."

Baseline characteristics tables were presented.

Wrenn 1997

  1. a

    BFI: Baby Friendly Initiative (UNICEF)
    EDD: expected date of delivery
    h: hour(s)
    HIV: Human Immunodeficiency Virus
    ICC: intracluster correlation co-efficient
    ITT: intention-to-treat
    LLLI: La Leche League International
    MB training: maternal breastfeeding training
    min: minute(s)
    NICU: neonatal intensive care unit
    pcm: per calendar month
    RCT: randomised controlled trial
    RG: Registrar General
    SCBU: special care baby unit
    SD: standard deviation
    SPSS: Statistical Package for the Social Sciences
    SSBC: supplementary structured breastfeeding counselling
    VLBW: very low birthweight
    WHO: World Health Organization
    WIC: Special Supplemental Nutrition Programme for Women, Infants and Children (US Department of Agriculture, Food and Nutrition Service)
    vs: versus

MethodsSingle-site, 2-group quasi-randomised study (even numbers to intervention and odd numbers to control group). Recruitment April 1999-February 2000, n = 186, with 79 assigned to the intervention and 107 to the control group.
Participants

Urban USA - military hospital in Texas. Background rates of breastfeeding initiation: Intermediate. Baseline breastfeeding rate in Texas at hospital discharge = 67% in 1999. All participants were members of the armed forces or their dependents.

Inclusion criteria: mothers on postpartum ward of study hospital; aged 18+; primiparous; uncomplicated delivery and postpartum; healthy baby; mother planned to breastfeed for at least 6 weeks.

Exclusion criteria: hospitalisation of mother or baby for > 4 days; mothers who did not speak English. Ethnic composition of sample: 63% white, 11% black, 20% Hispanic, 2% Asian, 3% other. .

Interventions

Control: standard care (not described).

Intervention: breastfeeding support in hospital visit lasting approximately 30 minutes, home visit 2-4 days after discharge lasting 45-60 minutes, and phone call 10-14 days after the home visit.

OutcomesBreastfeeding attrition to 6 weeks.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High riskAllocation by odd and even numbers in groups of 10.
Allocation concealment (selection bias)High riskCould be anticipated.
Blinding (performance bias and detection bias)
outcome assessors
High riskThe person delivering the intervention seems to have collected outcome data.
Incomplete outcome data (attrition bias)
All outcomes
High riskInformation on drop-outs incomplete and loss to follow-up not balanced across groups. 79 in intervention group, 5 were lost to follow-up, data at 6 weeks from 68. Outcome data were not obtained from 32 women in the control group at 6 weeks so more women were enrolled (107 enrolled to this group). Some breastfeeding duration data were obtained from drop-outs by phone.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskReplacing women in the control group lost to follow-up means that this study is at high risk of bias.

Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion
  1. a

    WIC: Special Supplemental Nutrition Programme for Women, Infants and Children (US Department of Agriculture, Food and Nutrition Service)

Agrasada 2005Low birthweight (LBW) infants. Under consideration for review of support for mothers breastfeeding infants who are not term and healthy.
Ahmed 2008Premature infants. Under consideration for review of support for mothers breastfeeding infants who are not term and healthy.
Ball 2011The intervention examined in this trial is not a breastfeeding support intervention. The trial examined the use of a baby cot that was clamped onto the side of the mother's bed so that the baby was within easy reach of the mother at all times.
Baqui 2008Excluded as the only breastfeeding outcome reported is "breastfeeding within one hour".
Barlow 2006Educational intervention not intended to facilitate continued breastfeeding.
Barnet 2002Intervention did not have the purpose of facilitating continued breastfeeding.
Black 2001Intervention did not have the purpose of facilitating continued breastfeeding.
Bolam 1998Evaluates an educational intervention.
Brown 2008Low birthweight (LBW) infants. Under consideration for review of support for mothers breastfeeding infants who are not term and healthy.
Cattaneo 2001Intervention was staff training, and participants were hospitals.
Caulfield 1998Not a randomised controlled trial (see Dyson et al).
Chapman 2011This study specifically focused on women with obesity. The study will be considered for inclusion in a proposed review on breastfeeding support for women at high risk of health problems that affect breastfeeding.
Davies-Adetugbo 1996Controlled study of breastfeeding counselling intervention without randomisation.
Davies-Adetugbo 1997Infants with diarrhoea. Under consideration for review of support for mothers breastfeeding infants who are not term and healthy.
Ebbeling 2007Not a randomised controlled trial.
Ferrara 2008Participants were women with gestational diabetes. Under consideration for review of support for mothers with conditions affecting/ affected by breastfeeding.
Finch 2002Evaluates an antenatal educational and marketing intervention. Both groups received postnatal breastfeeding support. Under consideration for the review Interventions for promoting the initiation of breastfeeding (Dyson et al).
Forster 2004Evaluates an educational intervention.
Forster 2006Antenatal intervention with no postnatal component.
Gagnon 1997Intervention not relevant for this review. The intervention was an alternative to standard care. The intervention was not aimed at facilitating breastfeeding, rather the trial compared women who were randomised to early hospital discharge with telephone follow-up (with home visits by nurses only for those women who left hospital within 36 hours of the birth “to encourage them to leave the hospital early”) versus usual care with later discharge from hospital. It was not clear that the intervention included any breastfeeding support. Although outcomes included breastfeeding the main focus was on “maternal competence” and infant outcomes.44% post-randomisation exclusions.
Garcia-Montrone 1996Educational intervention. Controls were matched, but not randomised.
Gijsbers 2006This study focused on families with a history of asthma.
Guise 2003Paper is a review.
Haider 1996Infants with diarrhoea. Under consideration for review of support for mothers breastfeeding infants who are not term and healthy.
Hall 2007Not a randomised controlled trial (groups not concurrent). Sub-study asking open-ended questions.
Hauck 1994Intervention was a booklet and did not involve contact with an individual.
Henderson 2001Evaluates an educational intervention.
Isselmann 2006Educational intervention which does not have the purpose of facilitating continued breastfeeding.
Jakobsen 2008Educational intervention.
Jang 2008Not a randomised controlled trial (groups not concurrent).
Johnston 2001This study examined an intervention carried out in the antenatal period.
Jones 2004Evaluates an education intervention. In this study women were offered specialist lactation advice by the researcher regarding returning to work and milk expression. This was a 1-hour evidence based session and was reinforced with a written leaflet. Results were reported for those women still breastfeeding on their return to work.
Junior 2007Very low birthweight (VLBW) infants. Under consideration for review of support for mothers breastfeeding infants who are not term and healthy.
Kistin 1994Non-randomised observational study.
Labarere 2003Evaluates an educational intervention.
Lavender 2004Evaluates an educational intervention.
Lewin 2005Paper is a review.
Lieu 2000Support was not supplementary to standard care.
MacArthur 2002Intervention was not breastfeeding support. No breastfeeding outcomes reported.
MacArthur 2009Antenatal intervention with no postnatal component.
Mannan 2008Results from this study were not reported according to randomisation group.
Mattar 2003Evaluates an educational intervention.
McInnes 2000Geographical controls.
McLeod 2003This study specifically focused on smoking and the aim of the support intervention was to encourage women to quit or reduce smoking in pregnancy although breastfeeding outcomes were reported. The study will be considered for inclusion in a proposed review on breastfeeding support for women at high risk of health problems that affect breastfeeding.
Merewood 2006Infants in neonatal intensive care. Under consideration for review of support for mothers breastfeeding infants who are not term and healthy.
Moore 1985Participants in this study may not have been healthy mothers. We excluded this study as it focused on parents with eczema or asthma and was examining the impact of a breastfeeding intervention on the occurrence of these diseases in babies.
Moreno-Manzanares 1997Correspondence with author established study was controlled but not randomised.
Neyzi 1991It was not clear that this was a randomised trial. Only 66% follow-up in intervention group.
Noel-Weiss 2006Antenatal intervention with no postnatal component.
Nor 2009Not a randomised controlled trial. Qualitative study looking at women’s views of peer counselling.
Olenick 2011The intervention took place before the birth; there was no postnatal component.
Pascali-Bonaro 2004Paper is not about a trial.
Perez-Escamilla 1992Study controlled but not randomised.
Peterson 2002Both groups received WIC breastfeeding education. The intervention group received social support for maternal diet, activity and weight loss outcomes.
Phillips 2010This study only recruited women whose babies were admitted to neonatal intensive care. Breastfeeding support for mothers of poorly babies will be considered in a separate review.
Pinelli 2001Very low birthweight infants. Under consideration for review of support for mothers breastfeeding infants who are not term and healthy.
Pollard 2011This study did not examine a breastfeeding support intervention by professionals or peers. The intervention group completed daily feeding logs recording breastfeeding practices.
Rasmussen 2011This study specifically focused on women with obesity. The study will be considered for inclusion in a proposed review on breastfeeding support for women at high risk of health problems that affect breastfeeding.
Ratner 1999Intervention did not have the purpose of facilitating continued breastfeeding.
Rea 1999Training intervention with no data on breastfeeding women.
Reeve 2004Evaluated an antenatal education intervention.
Rossiter 1994Educational intervention.
Rowe 1990Abstract only available. No information on intervention used.
Rush 1991Trial of hospital telephone help-line. The intervention was an invitation to call a general telephone support line in the postnatal period; the help-line was available to women in the control group but this new service development was not promoted with this group. The aim of the study was to examine the uptake of this service (i.e. reasons for and number of calls to the help-line and to other hospital departments from control and intervention women). The intervention was general and was not specifically to encourage breastfeeding; breastfeeding and breastfeeding duration were not measured.
Sakha 2008All the participants had given birth by caesarean section. Both groups received an educational intervention. 1 group received a drug to promote lactation.
Schy 1996Evaluates a purely educational intervention.
Sciacca 1995Support intervention available to all women in the trial.
Segura-Millan 1994Study controlled but not randomised.
Serrano 2010The intervention examined in this study is baby massage and not breastfeeding support. Breastfeeding was reported as a secondary outcome.
Sisk 2006Not a randomised controlled trial.
Steel O'Connor 2003Support was not supplementary to standard care.
Susin 2008Participants were not randomised.
Thomson 2009Both groups received support as part of standard care. The intervention was not breastfeeding support.
Thussanasupap 2006Educational intervention. Not a randomised controlled trial (assignment was 30 then another 30).
Valdes 2000Study controlled but not randomised.
Wallace 2006This study was excluded as it examined a brief educational intervention by midwives advising mothers on the correct positioning of the baby for breastfeeding.
Westphal 1995Intervention was training, and participants were hospitals.
Wiggins 2005Evaluates a social support intervention.
Wockel 2009This study examined an intervention aimed at fathers which was offered as part of antenatal childbirth preparation classes. There was no postnatal component to the intervention.

Characteristics of studies awaiting assessment [ordered by study ID]

Nunes 2011

  1. a

    RCT: randomised controlled trial

MethodsRCT with 4 groups: 1) mother and grandmother not cohabiting, without intervention; 2) mother and grandmother not cohabiting, with intervention directed only toward mother; 3) mother and grandmother cohabiting, without intervention; 4) mother and grandmother cohabiting, with intervention directed toward both.
ParticipantsAdolescent mothers and maternal grandmothers in Brazil.
Interventions6 breastfeeding counselling sessions; the first on the maternity ward and the others at home on days 7, 15, 30, 60 and 120.
OutcomesThe primary outcome was initiation of water and/or tea intake in the first 6 months of life. These were not reported in a way we could use for analyses in RevMan. We are awaiting further information on breastfeeding outcomes.
Notes 

Characteristics of ongoing studies [ordered by study ID]

Bonuck 2008

Trial name or titleThe Best Infant Nutrition for Good Outcomes (BINGO) trial.
MethodsA randomised, controlled, single centre, single blind, 2 x 2 factorial design.
Participants

Inclusion criteria include:

1. enrolled/plan to remain in care at the site throughout their pregnancy;

2. 1st or 2nd trimester (randomisation will include trimester as a blocking factor);

3. aged 18 or older;

4. can provide a reliable phone number and at least 2 alternative contacts;

5. are carrying a singleton pregnancy;

6. can communicate in English or Spanish.

 

Exclusion criteria include:

1. high risk of prematurity/NICU;

2. medical/obstetrical complications for which BF is or may be perceived to be contra-indicated.

Interventions

Women will be randomised into 4 groups: PNC; LC; both (PNC and LC) and a control group.

PNCs (certified nurse-midwives and obstetrician/gynaecologist doctors) will use a brief, electronically prompted protocol with women in the PNC groups throughout pregnancy. A LC will arrange prenatal 1-to-1 meetings, daily hospital and home visits with women in the LC intervention groups.

Outcomes

Primary outcomes: breastfeeding intensity and exclusive breastfeeding at 1, 3 and 6 months.

Secondary outcomes: infant health and participant and provider (PNC and LC) experiences of the interventions.

Starting dateFebruary 2008 until February 2012.
Contact informationkbonuck@montefiore.org
NotesStudy (BINGO) is ongoing. Due to be completed Feb 2012.

Eneroth 2007

Trial name or titlePart of the MINIMat study.
MethodsRCT.
ParticipantsWomen in Bangladesh.
InterventionsCounselling to promote exclusive breastfeeding. Including 7 or 8 home visits.
OutcomesExclusive breastfeeding and infant health outcomes.
Starting dateNot clear.
Contact informationUppsala University, Sweden.
NotesPart of the MINIMat study. Unclear whether the participants of the MINIMat study would be classified as healthy or not for the purposes of our review. MINIMat is not yet published.

Patel 2011

  1. a

    bf: breastfeeding
    LC: lactation consultant
    NICU: neonatal intensive care unit
    PNC: prenatal care provider
    RCT: randomised controlled trial

Trial name or titleEvaluation of the effectiveness of cell phone technology as community based intervention to improve exclusive breastfeeding and reduce infant morbidity rates.
MethodsCluster-randomised trial.
ParticipantsStaff training to promote breastfeeding.
Interventions

All the women in the trial will receive hospital maternity care at hospitals using BFHI (WHO/Unicef Baby Friendly Hospital Initiative) training for staff.

Women in control group clusters: existing staff at the hospitals will be encouraged to set up their own systems to continue counselling during the antenatal period, at delivery and during immunisation visits.

Women in intervention group clusters will receive, in addition to counselling in the hospitals during the scheduled antenatal visits, personalised lactation consultation and support via cell phone (handsets provided). Cell phone counselling will continue until 24 weeks after the birth.

Outcomes

Primary outcome: exclusive breastfeeding at 24 weeks

Secondary outcomes: timely initiation of breastfeeding, timely initiation of complimentary feeding, duration of any breastfeeding, infant growth, hospital admissions/mortality for infants and mothers, maternal satisfaction, cost effectiveness.

Starting dateAugust 2010.
Contact informationceuiggmc@yahoo.co.in
NotesClinical Trials.gov accessed 14 December 2011 showed "This study is currently recruiting participants" with the verification date June 2011.