Continuous support for women during childbirth

  • Review
  • Intervention

Authors


Abstract

Background

Historically, women have been attended and supported by other women during labour. However, in hospitals worldwide, continuous support during labour has become the exception rather than the routine.

Objectives

Primary: to assess the effects of continuous, one-to-one intrapartum support compared with usual care. Secondary: to determine whether the effects of continuous support are influenced by: (1) routine practices and policies; (2) the provider's relationship to the hospital and to the woman; and (3) timing of onset.

Search methods

We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 May 2013).

Selection criteria

All published and unpublished randomised controlled trials comparing continuous support during labour with usual care.

Data collection and analysis

We used standard methods of The Cochrane Collaboration Pregnancy and Childbirth Group. Two review authors independently evaluated methodological quality and extracted the data. We sought additional information from the trial authors. We used random-effects analyses for comparisons in which high heterogeneity was present, and we reported results using the average risk ratio (RR) for categorical data and mean difference (MD) for continuous data.

Main results

Twenty-two trials involving 15,288 women met inclusion criteria and provided usable outcome data. Results are of random-effects analyses, unless otherwise noted. Women allocated to continuous support were more likely to have a spontaneous vaginal birth (RR 1.08, 95% confidence interval (CI) 1.04 to 1.12) and less likely to have intrapartum analgesia (RR 0.90, 95% CI 0.84 to 0.96) or to report dissatisfaction (RR 0.69, 95% CI 0.59 to 0.79). In addition, their labours were shorter (MD -0.58 hours, 95% CI -0.85 to -0.31), they were less likely to have a caesarean (RR 0.78, 95% CI 0.67 to 0.91) or instrumental vaginal birth (fixed-effect, RR 0.90, 95% CI 0.85 to 0.96), regional analgesia (RR 0.93, 95% CI 0.88 to 0.99), or a baby with a low five-minute Apgar score (fixed-effect, RR 0.69, 95% CI 0.50 to 0.95). There was no apparent impact on other intrapartum interventions, maternal or neonatal complications, or breastfeeding. Subgroup analyses suggested that continuous support was most effective when the provider was neither part of the hospital staff nor the woman's social network, and in settings in which epidural analgesia was not routinely available. No conclusions could be drawn about the timing of onset of continuous support.

Authors' conclusions

Continuous support during labour has clinically meaningful benefits for women and infants and no known harm. All women should have support throughout labour and birth.

Résumé scientifique

Soutien continu aux femmes pendant l'accouchement

Contexte

Historiquement, les femmes ont été assistées et prises en charge par d'autres femmes pendant le travail. Cependant, dans les hôpitaux du monde entier, le soutien continu durant le travail est devenu l'exception plutôt que la règle.

Objectifs

Premièrement: évaluer les effets du soutien intrapartum en tête-à-tête, continu, comparé aux soins habituels. Deuxièmement: déterminer si les effets du soutien continu sont influencés par: (1) les pratiques et les politiques courantes; (2) la relation du prestataire à l'hôpital et à la femme; et (3) le moment du démarrage du soutien.

Stratégie de recherche documentaire

Nous avons effectué des recherches dans le registre des essais cliniques du groupe Cochrane sur la grossesse et la naissance (31 mai 2013).

Critères de sélection

Tous les essais contrôlés randomisés publiés et non publiés, comparant le soutien continu pendant le travail aux soins habituels.

Recueil et analyse des données

Nous avons utilisé les méthodes standards du groupe de collaboration Cochrane sur la grossesse et la naissance. Deux auteurs ont indépendamment évalué la qualité méthodologique et extrait les données. Nous avons recherché des informations supplémentaires auprès des auteurs des essais. Nous avons utilisé les analyses selon un modèle à effets aléatoires pour les comparaisons dans lesquelles une forte hétérogénéité était présente et nous avons rendu compte des résultats en utilisant le risque relatif (RR) pour les données catégorielles et la différence moyenne (DM) pour les données continues.

Résultats principaux

Vingt-deux essais impliquant 15 061 femmes remplissaient les critères d'inclusion et ont fourni des données de résultat utilisables. Les résultats sont issus d'analyses selon un modèle à effets aléatoires, sauf indication contraire. Les femmes affectées au soutien continu étaient plus susceptibles d'avoir une naissance spontanée par voie basse (RR 1,08, IC à 95% 1,04 à 1,12) et moins susceptibles d'avoir une analgésie intrapartum (RR 0,90, IC à 95% 0,84 à 0,96) ou de signaler une insatisfaction (RR 0,69, IC à 95 % 0,59 à 0,79). En outre, leurs durées de travail étaient plus courtes (DM 0,58 heures, IC à 95%, 0,85 à 0,31), elles étaient moins susceptibles d'avoir une césarienne (RR 0,78, IC à 95 % 0,67 à 0,91) ou un accouchement par voie basse instrumental (effet fixe, RR 0,90, IC à 95 % 0,85 à 0,96), une analgésie régionale (RR 0,93, IC à 95 % 0,88 à 0,99), ou un bébé avec un faible score d'Apgar à 5 minutes (effet fixe, RR 0,69, IC à 95 % 0,50 à 0,95).

Il n'y avait apparemment aucune incidence sur les autres interventions intrapartum, les complications maternelles ou néonatales, ou sur l'allaitement maternel. Les analyses en sous-groupes suggéraient que le soutien continu était le plus efficace lorsqu'il était fourni par une femme qui n'était membre ni du personnel de l'hôpital ni du réseau social de la femme, et dans les infrastructures dans lesquelles l'analgésie péridurale n'était pas systématiquement disponible. Aucune conclusion n'a pu être tirée quant au moment du démarrage du soutien continu.

Conclusions des auteurs

Le soutien continu pendant le travail a des avantages cliniquement significatifs pour les femmes et les nourrissons et n'a aucun préjudice connu. Toutes les femmes devraient bénéficier d'un soutien tout au long du travail et de l'accouchement.

Resumo

Apoio contínuo para mulheres em trabalho de parto

Introdução

HHistoricamente, as mulheres em trabalho de parto tem sido atendidas e apoiadas por outras mulheres. Porém, em hospitais de todo o mundo, o apoio contínuo durante o trabalho de parto tem se tornado exceção e não rotina.

Objetivos

Primário: avaliar os efeitos do apoio contínuo individual durante o período intraparto comparado à assistência habitual. Secundários: avaliar se os efeitos do apoio contínuo são influenciados por: (1) políticas e práticas rotineiras; (2) a relação da pessoa que oferece o apoio (provedor) com o hospital e com a mulher; e (3) o momento do início da intervenção.

Métodos de busca

Foi feita uma busca no Cochrane Pregnancy and Childbirth Group’s Trials Register (31 de Maio de 2013).

Critério de seleção

Todos os ensaios clínicos randomizados publicados e não publicados comparando apoio contínuo durante o trabalho de parto versus assistência habitual ao trabalho de parto.

Coleta dos dados e análises

Os métodos habituais recomendados pelo Pregnancy and Childbirth Group da Colaboração Cochrane foram seguidos. Dois revisores independentes avaliaram a qualidade metodológica e extraíram os dados dos estudos. Os autores dos ensaios clínicos foram contatados para se obter mais informações. Nas comparações com alto grau de heterogeneidade, foram usados métodos de análise para efeitos randômicos. Os resultados de dados categóricos são apresentados como razão de riscos (risk ratio, RR) e os resultados de dados contínuos são apresentados com diferença média (mean difference, MD).

Principais resultados

Vinte e dois ensaios clínicos envolvendo um total de 15.288 mulheres preencheram os critérios de inclusão e tinham dados de desfecho que puderam ser usados. Os resultados apresentados a seguir usaram o modelo de efeito randômico, exceto nos casos especificamente citados no texto. As parturientes que receberam apoio contínuo tiveram maior probabilidade de terem um parto vaginal espontâneo (RR 1,08, intervalo de confiança (IC) de 95% 1,04 a 1,12) e menor probabilidade de receberem analgesia intraparto (RR 0,90, IC95% 0,84 a 0,96) ou de se sentirem insatisfeitas (RR 0,69, IC95% 0,59 a 0,79). Além disso, a duração do trabalho de parto das mulheres que receberam apoio contínuo foi mais curta (MD -0,58 horas, IC95% -0,85 a -0,31 horas), sua probabilidade de ter parto cesáreo foi menor (RR 0,78, IC95% 0,67 a 0,91) assim como de ter parto vaginal instrumental (efeito fixo, RR 0,90, IC95% 0,85 a 0,96), de necessitarem de analgesia regional (RR 0,93, IC95% 0,88 a 0,99) ou de terem um bebê com Apgar de 5 minutos baixo (efeito fixo, RR 0,69, IC95% 0,50 a 0,95). Não foram identificados outros efeitos do apoio contínuo sobre outras intervenções durante o trabalho de parto ou sobre outras complicações maternas ou neonatais, ou sobre a amamentação. As análises de subgrupo sugerem que o apoio contínuo é mais efetivo quando a pessoa que desempenha esse papel não faz parte da equipe hospitalar, nem de rede de apoio social da parturiente, e nos locais onde a analgesia peridural não é disponível de rotina. Não foi possível se chegar a nenhuma conclusão quanto ao momento do início do apoio contínuo.

Conclusão dos autores

O apoio contínuo durante o trabalho de parto traz benefícios clínicos significativos para as mulheres e seus bebês, sem provocar nenhum dano evidente. Todas as mulheres deveriam receber apoio contínuo durante o trabalho de parto e parto.

摘要

兒童出生期間對產婦的持續支持

背景

歷史上而言,分娩期間婦女是由其他女性照顧與支持。然而,在全世界的醫院中,分娩時的持續性支持變成例外而非慣例。

目的

主要: 想要評估持續性效果、一對一產間支持與一般照護比較。其次: 測定持續性支持的效果是否受下列因素影響: (1) 慣例實行與政策; (2) 提供照顧者與醫院及產婦的關係;以及 (3) 開始照顧的時機。

搜尋策略

我們搜尋了考科藍孕期與出生群組試驗註冊(2012年6月30日)

選擇標準

所有已發表與未發表的隨機對照試驗,比較分娩期間的持續性支持與一般照護。

資料收集與分析

我們利用考科藍合作組織孕期與出生群組的標準方法。兩位審閱作者各自獨立的評估方法學品質並摘錄數據。我們並由試驗作者取得額外資訊 。在出現高異質性時,我們採用隨機效果分析進行比較,我們並使用平均風險比(RR)報告明確分類的數據以及使用平均數差異(MD)來報告持續性數據。

主要結果

22個試驗涵蓋15,288名婦女符合採用準則,並提供可用的數據。除非另有註明結果採用隨機效果分析,。產婦各在持續性照顧較有可能採用自然生產(RR 1.08, 95%信賴區間(CI) 1.04 to 1.12)且較不用產間止痛 (RR 0.90, 95% CI 0.84 to 0.96)或回報不滿的現象(RR 0.69, 95% CI 0.59 to 0.79)。此外,它們的分娩時間也較短(MD -0.58 小時, 95% CI -0.85 to -0.31),她們較少用剖腹產 (RR 0.78, 95% CI 0.67 to 0.91)或以器具輔助陰道生產(固定效果, RR 0.90, 95% CI 0.85 to 0.96)、或區域性止痛 (RR 0.93, 95% CI 0.88 to 0.99)、或嬰兒有低於5分鐘的Apgar分數 (固定效果, RR 0.69, 95% CI 0.50 to 0.95)。其他產間干預、母親或新生兒併發症、或母乳哺育上也沒有明顯影響。當提供者不是醫院員工部分也不是母親交往社群,以及硬膜外麻醉止痛方式非例行可得時,子群組分析顯示持續性照顧最為有效。持續性照顧開始時機相關結論無法做相。

作者結論

分娩期間的持續性支持對婦女與嬰兒有臨床上有意義的益處且無已知危害。所有婦女應在分娩與嬰兒出生時得到支持。

Zusammenfassung

Kontinuierliche unterstützende Betreuung für Frauen während des Geburtsprozesses

Hintergrund

Geschichtlich betrachtet wurden Frauen während des Geburtsprozesses schon immer von anderen Frauen begleitet und unterstützt. Dennoch ist eine kontinuierliche Betreuung während der Geburt in Krankenhäusern weltweit nicht die Regel, sondern die Ausnahme geworden.

Ziele

Primärer Endpunkt: die Wirkungen von kontinuierlicher, intrapartaler persönlicher Betreuung verglichen mit der üblichen routinemäßigen Betreuung zu bewerten. Sekundäre Endpunkte: herauszufinden, ob die Auswirkungen einer kontinuierlichen Betreuung beeinflusst werden von: (1) Routinepraktiken und Richtlinien; (2) der Beziehung der betreuenden Person zum Krankenhaus und zur Frau; und (3) dem Zeitpunkt des Betreuungsbeginns.

Literatursuche

Wir suchten im Cochrane Pregnancy and Childbirth Group’s Trials Register (31. Mai 2013).

Auswahlkriterien

Alle veröffentlichten und unveröffentlichten randomisierten kontrollierten Studien, welche kontinuierliche Betreuung während des Geburtsprozesses mit der üblichen routinemäßigen Betreuung vergleichen.

Datenerhebung und -analyse

Wir nutzten die Standardmethoden der Cochrane Collaboration Pregnancy and Childbirth Group. Zwei Review-Autoren bewerteten unabhängig voneinander die methodische Qualität und extrahierten die Daten. Wir bemühten uns zusätzlich um Informationen von den Studienautoren. Wir wandten das Random-Effects-Model für Vergleiche in welchen eine hohe Heterogenität vorlag an und beschrieben die Ergebnisse, indem wir die mittlere Risk Ratio (RR) für kategoriale Daten und die mittlere Differenz (MD) für kontinuierliche Daten verwendeten.

Wesentliche Ergebnisse

22 Studien mit 15.288 Frauen erfüllten die Einschlusskriterien und lieferten brauchbare Daten zu den Endpunkten. Die Ergebnisse basieren, sofern nicht anders vermerkt, auf einer Analyse mit dem Random-Effects-Model. Für Frauen, die der kontinuierlichen Betreuung zugewiesen waren, war es wahrscheinlicher eine spontane vaginale Geburt zu haben (RR 1,08; 95% Konfidenzintervall (KI) 1,04 – 1,12) und weniger wahrscheinlich eine intrapartale Analgesie zu bekommen (RR 0,90; 95% KI 0,84 – 0,96) oder Unzufriedenheit zu berichten (RR 0,69; 95% KI 0,59 – 0,79). Außerdem waren ihre Geburten kürzer (MD - 0,58 Stunden; 95% KI - 0,85 – -0,31), sie hatten eine geringere Wahrscheinlichkeit für einen Kaiserschnitt (RR 0,78; 95% KI 0,67 – 0,91) oder eine vaginal-operative Geburt (Fixed-Effect-Model, RR 0,90; 95% KI 0,85 – 0,96), eine Regionalanalgesie (RR 0,93; 95% CI 0,88 – 0,99), oder ein Neugeborenes mit einem geringen 5-Minuten-Apgar Score (Fixed-Effect-Model, RR 0,69; 95% KI 0,50 – 0,95). Es gab keinen offensichtlichen Einfluss auf andere intrapartale Interventionen, maternale oder neonatale Komplikationen oder das Stillen. Subgruppen Analysen deuteten darauf hin, dass eine kontinuierliche Betreuung am effektivsten war, wenn die betreuende Person weder Teil des Krankenhauspersonals noch Teil des sozialen Netzwerks der Frau war, sowie in Einrichtungen, in denen eine Periduralanalgesie nicht routinemäßig verfügbar war. Es konnten keine Schlussfolgerungen in Bezug auf den Zeitpunkt des Beginns der kontinuierlichen Betreuung gezogen werden.

Schlussfolgerungen der Autoren

Eine kontinuierliche Betreuung während der Geburt hat einen klinisch relevanten Nutzen für Frauen und Säuglinge und führt zu keinem bekannten Schaden. Jede Frau sollte während der Wehen und der Geburt Unterstützung haben.

Anmerkungen zur Übersetzung

N. Peterwerth, freigegeben durch Cochrane Deutschland.

アブストラクト

出産時の女性に対する継続的な支援

背景

歴史的に、分娩時には他の女性が付き添って介助を行ってきた。しかし、世界的に見て、病院では分娩時の継続的サポートは特別な場合にのみ実施され、ルーチンではなくなった。

目的

主要目的:分娩時の継続的個別サポートの効果を通常のケアと比較評価すること。副次目的:継続的サポートの効果が、(1)通常診療および指針、(2)医療提供者と病院および分娩者との関係、(3)サポートの開始時期、の影響を受けるかどうかを検証すること。

検索戦略

Cochrane Pregnancy and Childbirth Group’s Trials Registerを検索した(2013年5月31日)。

選択基準

分娩時の継続的サポートを通常のケアと比較した、既報および未発表のすべてのランダム化比較試験。

データ収集と分析

Cochrane Collaboration Pregnancy and Childbirth Groupの標準法を用いた。2名のレビュー著者が独立して方法論の質を評価し、データを抽出した。試験著者に追加情報を照会した。異質性が高い場合はランダム効果解析を用いて比較し、また、カテゴリカルデータは平均リスク比(RR)を、連続データは平均差(MD)を用いて結果を報告した。

主な結果

15,288例が参加した22件の試験が選択基準を満たし、利用可能なアウトカムデータが得られた。特別な記載がない限り、ランダム効果解析の結果を示す。継続的サポート群に割り付けられた女性では自然経膣分娩の割合が高く(RR 1.08, 95%信頼区間[CI]1.04〜1.12)、無痛分娩の割合(RR 0.90, 95%CI 0.84〜0.96)または不満を訴える割合(RR 0.69, 95%CI 0.59〜0.79)が低かった。さらに、分娩時間が短縮し(MD -0.58時間, 95%CI -0.85〜- 0.31)、帝王切開(RR 0.78, 95%CI 0.67〜0.91)または経膣介助分娩(固定効果, RR 0.90, 95%CI 0.85〜0.96)、局所麻酔(RR 0.93, 95%CI 0.88〜0.99)および5分アプガースコアが低値の新生児(固定効果, RR 0.69, 95%CI 0.50〜0.95)の割合が低かった。その他の分娩時介入、母体もしくは新生児の合併症または母乳哺育に対する明らかな影響は認められなかった。サブグループ解析では、継続的サポートの効果は、提供者が病院職員や分娩者の知人ではなく、硬膜外麻酔が日常的に利用できない状況下で最大となることが示唆された。継続的サポートの開始時期に関する結論を導くことはできなかった。

著者の結論

分娩時の継続的サポートは女性および新生児に対して臨床的に有意な有益性をもたらし、既知の有害性は認められない。すべての女性が陣痛・娩出期間を通じてサポートを受けるべきである。

訳注

《実施組織》厚生労働省「「統合医療」に係る情報発信等推進事業」(eJIM:http://www.ejim.ncgg.go.jp/)[2015.12.29]《注意》この日本語訳は、臨床医、疫学研究者などによる翻訳のチェックを受けて公開していますが、訳語の間違いなどお気づきの点がございましたら、eJIM事務局までご連絡ください。なお、2013年6月からコクラン・ライブラリーのNew review, Updated reviewとも日単位で更新されています。eJIMでは最新版の日本語訳を掲載するよう努めておりますが、タイム・ラグが生じている場合もあります。ご利用に際しては、最新版(英語版)の内容をご確認ください。

Plain language summary

Continuous support for women during childbirth

Continuous support in labour increased the chance of a spontaneous vaginal birth, had no harm, and women were more satisfied.

Historically women have been attended and supported by other women during labour and birth. However in many countries, as more women are giving birth in hospital rather than at home, continuous support during labour has become the exception rather than the norm. This may contribute to the dehumanisation of women's childbirth experiences. Modern obstetric care frequently subjects women to institutional routines, which may have adverse effects on the progress of labour. Supportive care during labour may involve emotional support, comfort measures, information and advocacy. These may enhance physiologic labour processes as well as women's feelings of control and competence, and thus reduce the need for obstetric intervention. The review of studies included 23 trials (22 providing data), from 16 countries, involving more than 15,000 women in a wide range of settings and circumstances. The continuous support was provided either by hospital staff (such as nurses or midwives), women who were not hospital employees and had no personal relationship to the labouring woman (such as doulas or women who were provided with a modest amount of guidance), or by companions of the woman's choice from her social network (such as her husband, partner, mother, or friend). Women who received continuous labour support were more likely to give birth 'spontaneously', i.e. give birth with neither caesarean nor vacuum nor forceps. In addition, women were less likely to use pain medications, were more likely to be satisfied, and had slightly shorter labours. Their babies were less likely to have low five-minute Apgar scores. No adverse effects were identified. We conclude that all women should have continuous support during labour. Continuous support from a person who is present solely to provide support, is not a member of the woman's social network, is experienced in providing labour support, and has at least a modest amount of training, appears to be most beneficial. In comparison with having no companion during labour, support from a chosen family member or friend appears to increase women's satisfaction with their childbearing experience.

Résumé simplifié

Soutien continu aux femmes pendant l'accouchement

Le soutien continu pendant le travail a augmenté les chances d'une naissance spontanée par voie basse, n'était pas néfaste, et les femmes étaient davantage satisfaites.

Historiquement, les femmes ont été assistées et prises en charge par d'autres femmes pendant le travail et l'accouchement. Cependant, dans de nombreux pays, de plus en plus de femmes accouchent à l'hôpital plutôt qu'à la maison et le soutien continu durant le travail est devenu l'exception plutôt que la règle. Lexpérience de la naissance auprès des femmes peut par conséquent être déshumanisée. Les soins obstétriques modernes soumettent fréquemment les femmes à des routines institutionnelles, qui peuvent avoir des effets défavorables sur la progression du travail. Les soins de soutien durant le travail peuvent impliquer un soutien émotionnel, des mesures relatives au confort, des informations et des recommandations. Ceux-ci peuvent améliorer le processus physiologique du travail ainsi que les sentiments de contrôle et de compétence éprouvés par les femmes et réduire ainsi la nécessité d'une intervention obstétrique. La revue des études a inclus 23 essais (22 fournissant des données), de 16 pays, impliquant plus de 15 000 femmes dans des contextes et des circonstances très variés. Le soutien continu a été fourni soit par le personnel hospitalier (tel que les infirmières ou les sages-femmes), soit par des femmes qui n'étaient pas des employées de l'hôpital et n'avaient aucune relation personnelle avec la femme en travail (telles que les doulas ou des femmes qui avaient reçu une modeste quantité de conseils), soit par des compagnons selon le choix de la femme issus de son réseau social (tels que son mari, son partenaire, sa mère, ou un(e) ami(e)). Les femmes ayant reçu un soutien continu pendant le travail avaient davantage tendance à donner naissance « spontanément », c'est-à-dire à donner naissance sans césarienne, ni aspiration, ni forceps. De plus, les femmes étaient moins susceptibles d'avoir recours à des médicaments contre la douleur, étaient le plus souvent satisfaites, et avaient des durées de travail légèrement plus courtes. Leurs bébés étaient moins susceptibles d'avoir un faible score d'Apgar bas à 5 minutes. Aucun effet indésirable na été identifié. Nous en concluons que toutes les femmes devraient avoir un soutien continu durant le travail. Un soutien continu de la part d'une personne qui est présente uniquement pour fournir un soutien, n'est pas membre du réseau social de la femme, a de l'expérience dans l'apport d'un soutien lors du travail, et a au moins une modeste formation, semble être le plus bénéfique. En comparant avec aucun compagnon pendant le travail, le soutien de la part d'un membre de la famille ou d'un(e) ami(e) semble accroître la satisfaction des femmes quant à leur expérience de l'accouchement.

Notes de traduction

Traduit par: French Cochrane Centre 12th November, 2013
Traduction financée par: Minist�re des Affaires sociales et de la Sant�

Laički sažetak

Kontinuirana podrška ženama tijekom poroda

Kontinuirana podrška za vrijeme poroda povećava vjerojatnost spontanog vaginalnog poroda, ne nanosi nikakvu štetu te su žene zadovoljnije.

Kroz povijest su ženama tijekom poroda pomagale i pružale podršku druge žene. No u mnogim zemljama, kako žene danas češće rađaju u bolnicama nego kod kuće, kontinuirana podrška tijekom poroda je postala iznimka, a ne pravilo. To može doprinijeti dehumanizaciji ženinog iskustva porođaja. Suvremena porodnička skrb često podvrgava žene rutinskim bolničkim postupcima što može imati štetne i neželjene učinke na tijek poroda. Podrška tijekom poroda može uključivati emocionalnu podršku, osiguravanje udobnosti, informiranje i zastupanje rodilje. Navedene mjere mogu poboljšati fiziološke procese poroda kao i ženin osjećaj kontrole i sposobnosti te umanjiti potrebu za opstetričkom intervencijom. U ovaj Cochrane sustavni pregled su analizom literature uključena 23 pokusa (22 su imala objavljene podatke) iz 16 zemalja, a uključivali su više od 15.000 žena u širokom rasponu parametara i okolnosti. Kontinuiranu podršku je pružalo osoblje bolnice (kao što su medicinske sestre i primalje), žene koje nisu zaposlenice bolnica te nisu osobno povezane s rodiljama (kao što su doule ili žene kojima su pružene osnovne smjernice) te pratnja iz ženinog društvenog kruga prema njenom izboru (kao što su suprug, životni partner, majka ili prijatelj). Žene koje su imale kontinuiranu podršku tijekom poroda su imale veću vjerojatnost „spontanog“ poroda tj. poroda bez carskog reza, upotrebe vakuuma ili forcepsa. Uz to, kod tih žena je smanjena vjerojatnost korištenja lijekova protiv bolova, povećana vjerojatnost zadovoljstva te ponešto skraćena dužina trajanja poroda. Kod njihove djece je smanjena vjerojatnost niskog Apgara u petoj minuti. Nisu uočeni nikakvi štetni učinci. Zaključak je da bi sve žene trebale imati kontinuiranu podršku tijekom poroda. Najkorisnijom se pokazala kontinuirana podrška osobe koja je prisutna samo s ciljem da pruži podršku, nije član ženinog društvenog kruga, iskusna je u pružanju podrške tijekom poroda i prošla je barem skromnu obuku. U usporedbi s porodom bez pratnje, podrška odabranog člana obitelji ili prijatelja povećava zadovoljstvo žene s iskustvom poroda.

Bilješke prijevoda

Prevoditelj:: Croatian Branch of the Italian Cochrane Centre
Prijevod financira:: Ministry of Education, Science and Sports

Resumo para leigos

Apoio contínuo para mulheres durante o parto

O apoio contínuo durante o trabalho de parto aumenta as chances de se ter um parto vaginal espontâneo, não provoca danos, e as mulheres ficam mais satisfeitas.

Historicamente, as mulheres sempre foram atendidas e apoiadas por outras mulheres durante o trabalho de parto e parto. Porém, em muitos países, na medida em que mais mulheres passaram a dar à luz em hospitais em vez de terem partos domiciliares, o apoio contínuo durante o trabalho de parto tem se tornado exceção em vez de regra. Isso pode contribuir para a desumanização da experiência do parto para as mulheres. As práticas obstétricas modernas frequentemente sujeitam as mulheres a rotinas institucionais que podem ter efeitos prejudiciais sobre o processo do trabalho de parto. O apoio durante o trabalho de parto inclui oferecer suporte emocional, medidas de conforto, informações e intermediação a favor da parturiente. Essas ações podem ajudar o processo fisiológico do trabalho de parto a se desenvolver e aumentam a sensação de controle e de competência das parturientes, reduzindo assim a necessidade de intervenções obstétricas. Esta revisão incluiu 23 ensaios clínicos randomizados (22 com dados numéricos) realizados em 16 países, envolvendo mais de 15.000 mulheres em uma grande variedade de locais e circunstâncias. Nesses estudos, o apoio contínuo era oferecido por pessoas que eram parte da equipe hospitalar (como enfermeiras ou parteiras), ou por mulheres que não faziam parte da equipe hospitalar e não tinham nenhuma relação pessoal com as parturientes (como doulas ou mulheres que tinham um pequeno treinamento), ou então por pessoas escolhidas pela parturiente dentro da sua rede social (como marido, parceiro, mãe ou amiga). As mulheres que receberem apoio contínuo tiveram maior probabilidade de terem um parto vaginal espontâneo, isto é, de dar à luz sem ser por cesárea ou usando vácuo-aspirador ou fórcipe. Além disso, essas mulheres tiveram menor probabilidade de usar remédios para dor durante o trabalho de parto e maior probabilidade de se sentir mais satisfeitas; além disso, a duração do seu trabalho de parto foi um pouco menor. Seus bebês tiveram menor risco de ter uma nota baixa no Apgar de 5 minutos. O apoio contínuo não produziu nenhum efeito prejudicial. Concluímos que todas as mulheres deveriam ter apoio contínuo durante o trabalho de parto. A tipo de apoio contínuo durante o trabalho de parto mais benéfico parece ser aquele que é oferecido por uma pessoa que está lá apenas para isso, não sendo parte do círculo social da parturiente, que tenha experiência em oferecer apoio a parturientes e que tenha recebido algum tipo de treinamento para exercer este papel. O apoio de um parente ou amigo, em comparação com nenhum tipo de companhia, aumenta a satisfação da parturiente em relação à experiência do parto.

Notas de tradução

Traduzido por: Brazilian Cochrane Centre
Tradução patrocinada por: None

淺顯易懂的口語結論

兒童出生期間對產婦的持續支持

分娩中持續性支持增加自然生產的機會,而母親更為滿意。

歷史上婦女於生產時受其他女性照顧與支持。然而,許多國家因為婦女在醫院生產而非家中,讓持續性支持成為例外而非規範。此可造成婦女生產的非人性經驗。現代產科照護通常讓婦女受機構慣例支配,這對分娩過程可能有不良影響。分娩期間的支援性照護可能包括情緒上支持、舒適措施、資訊與鼓勵。這些可能提升生理分娩過程以及婦女對分娩的控制與勝任感,並因此降低產科干預的需要。研究的審閱包含23個試驗(22個提供數據),來自16個國家,涵蓋15,000婦女來自廣泛的環境與情形。持續性支援可由醫院護理人員(如護理師或助產士)提供、非醫院員工的女性以及與產婦無私人關係的女性(像是嬰兒生產時與後來負責照料的女性或是經提供適量引導的女性),或是來自產婦從交往社群選擇的同伴(像是先生、夥伴、母親或朋友)。接受持續性支持的婦女較有可能「自然」生產,例如:不以剖腹也非使用真空或產鉗方式。此外,婦女少使用疼痛藥物治療,較有可能滿意,且有稍微較短的分娩。它們的嬰兒較不可能有低的5分鐘Apgar分數。沒有找到不良效果。我們的結論是所有婦女應於分娩時接受持續性支持。來自現場僅提供支持的人員進行持續性支持,該人並非婦女交往社群成員,在提供分娩支持上有經驗,且至少有受過適量訓練者似乎最有助益。與分娩時無陪伴相比,來自選擇的家人或朋友的支持似乎可增加婦女生育經驗的滿意度。

譯註

翻譯: East Asian Cochrane Alliance
翻譯補助: 台灣衛生福利部/台北醫學大學實證醫學研究中心

Резюме на простом языке

Постоянная поддержка женщин во время родов

Постоянная (непрерывная) поддержка в родах увеличивала вероятность самостоятельных (спонтанных) вагинальных родов, не оказывала вреда, и женщины были более удовлетворены.

Исторически женщины получали участие и поддержку со стороны других женщин во время родов. Однако во многих странах все больше женщин рожают в больнице, а не дома, поэтому постоянная поддержка во время родов стала скорее исключением, чем нормой. Это может способствовать дегуманизации опыта деторождения. При современной акушерской практике женщины часто подвергаются установленным рутинным процедурам, которые могут оказать неблагоприятное воздействие на процесс родов. Поддержка и уход во время родов могут включать эмоциональную поддержку, меры по повышению комфортности, информирование и защиту. Эти меры могут улучшить процесс физиологических родов, так же как и чувства самоконтроля и уверенности у женщин, и тем самым уменьшить потребность в акушерских вмешательствах. В этот обзор исследований включены 23 клинических испытания (22 с предоставленными данными), из 16 стран, с участием более чем 15000 женщин, находящихся в широком разнообразии условий и обстоятельств Постоянная поддержка в родах была оказана либо персоналом больницы (например, медицинские сестры или акушерки), либо женщинами, которые не были сотрудниками больницы и не имели личных отношений с рожавшими женщинами (например, женщина-сиделка по уходу за роженицей или женщина со скромным опытом поддержки во время родов), либо знакомыми по выбору женщины из ее социальной сети (например, муж, партнер, мать или друг). При непрерывной поддержке в родах женщины более вероятно рожали 'спонтанно', то есть без проведения Кесарева сечения или использования вакуума или щипцов. Кроме того, женщины реже использовали обезболивающие лекарства, с более высокой вероятностью были удовлетворенными оказанной помощью. Длительность родов у таких женщин была немного короче. При оценке по шкале Апгар через 5 минут дети, рожденные от матерей с постоянной поддержкой в родах, с меньшей вероятностью имели низкие показатели. Не было выявлено никаких побочных эффектов. Мы пришли к выводу, что все женщины должны иметь постоянную поддержку во время родов. Постоянная поддержка, оказываемая человеком, который присутствует только для обеспечения поддержки, при этом не является членом социальной сети женщины, а имеет большой опыт в оказании поддержки во время родов, и, по крайней мере, был немного обучен этому, является, по-видимому, наиболее полезной. Поддержка члена семьи или друга, по-видимому, повышает уровень удовлетворенности женщин их опытом деторождения по сравнению с теми, кто не имел никакой поддержки.

Заметки по переводу

Заметки по переводу: Перевод: Кораблева Анна Александровна. Редактирование: Зиганшина Лилия Евгеньевна. Координация проекта по переводу на русский язык: Казанский федеральный университет. По вопросам, связанным с этим переводом, пожалуйста, свяжитесь с нами по адресу: lezign@gmail.com

எளியமொழிச் சுருக்கம்

பிரசவத்தின் போது பெண்களுக்கு தொடர் ஆதரவு (ஊக்கம்) தருவது

பிரசவத்தின் போது தொடர்ந்து ஆதரவு (ஊக்கம்) தருவது, ஒரு தன்னிச்சையான யோனிவழி பிறப்பின் வாய்ப்பை அதிகரித்தது, எந்த தீங்கும் இல்லை, மற்றும் பெண்கள் அதிக திருப்தி அடைந்தார்கள்.

காலம்காலமாக பிரசவத்தின் போது பெண்கள் மற்ற பெண்களால் கவனிக்க பட்டதோடு அவர்களிடமிருந்து ஆதரவும் கிடைக்கபெற்றார்கள். எனினும், பல நாடுகளில், அதிக எண்ணிக்கையில் பெண்கள் வீட்டிற்கு பதிலாக மருத்துவமனையில் குழந்தையை பெற்றெடுக்கிறார்கள். பிரசவத்தின் போது, தொடர் ஆதரவு என்பது விதியாக அல்லாமல் விதிவிலக்காகவே மாறிவிட்டது. இது பெண்களின் பிரசவ அனுபவங்கள் பாலுள்ள மனித நேயத்தை இழக்கும் படி செய்ததற்கு காரணமாக இருக்கலாம். நவீன மகப்பேறு பேணுகை பொதுவாக பெண்களை நிறுவன நடைமுறைகளுக்கு உட்படுத்துகின்றன. அது பிரசவத்தின் முன்னேற்றத்தில் பாதகமான விளைவுகளை உண்டுபண்ணலாம். பிரசவத்தின் போது காட்டும் ஆதரவு உணர்ச்சிபூர்வமான ஆதரவாக, பிரசவத்திற்கான வசதிகளை ஏற்படுத்தல் , தகவல் மற்றும் ஆலோசனை ஆகியவற்றை கொண்டவையாகயிருக்கலாம். இது பிரசவத்தின் உடலியல் செயல்முறைகளை மேம்படுத்துவதுடன் பெண்களின் கட்டுப்பாடு மற்றும் ஆற்றல் உணர்வுகளை அதிகரிக்கலாம். இதனால் மகப்பேறியல் தலையீட்டின் தேவையை குறைக்கலாம். பலதரப்பட்ட அமைப்புகள் மற்றும் சூழ்நிலைகளில், 15,000 க்கும் மேற்பட்ட பெண்கள் கொண்டு, 16 நாடுகளில் மேற்கொண்ட 23 சோதனைகள் (22 ஆய்வுகளின் தரவுகள் கொண்டது) இந்த திறனாய்வில் சேர்க்கப்பட்டுள்ளது. தொடர் ஆதரவு, ஒன்று மருத்துவமனை ஊழியர்கள் (செவிலி அல்லது செவிலித்தாய் போன்றவர்கள்) அல்லது வைத்தியசாலை ஊழியர்கள் அல்லாத மற்றும் பிரசவ பெண்களுக்கு உறவும் அல்லாத பெண்கள் (சுமாரான அளவு வழிகாட்டல் வழங்கப்பட்ட மகப்பேறில் உதவ முறைப்படி கற்ற அல்லது பெண்கள் போன்றவர்கள்) அல்லது பிரசவ பெண்களின் விருப்பப்படி அவர்களின் சமுகத்தில் உள்ள நபித்தோழர்கள் (அவரது கணவர், கூட்டாளி, தாயார், நண்பர் போன்றவர்கள்) போன்றவர்களால் வழங்கப்பட்டுள்ளது. தொடர்ச்சியான பிரசவ ஆதரவு பெற்ற பெண்கள் தன்னிச்சையாக குழந்தையை பெற்றெடுக்க அதாவது, அறுவை வழிப்பேறு (சிசேரியன்) இல்லாமலும் அல்லது வெற்றிடம் அல்லது இடுக்கி இழுவையால் பெறல் (ஃபோர்செப்ஸ்) இல்லாமலும் பெற்றெடுக்க அதிக வாய்ப்பு இருந்தது. மேலும், பெண்களுகள், வலி மருந்துகள் பயன்படுத்துவதற்கான வாய்ப்பு குறைவாகவே இருந்தது, திருப்தி அதிகமாக இருந்தது, மற்றும் பிரசவ நேரம் சற்று குறைவாக இருந்தது. அவர்களின் குழந்தைகள் ஐந்து நிமிட அப்கார் (Apgar) அளவீட்டில் குறைந்த மதிப்பெண்ணுடன் இருக்க வாய்ப்பு குறைவாகவே இருந்தது. இதில் பாதகமான விளைவுகள் ஏதும் அடையாளம் காணப்படவில்லை. நாங்கள் அனைத்து பெண்களுக்கும் பிரசவத்தின் போது, தொடர் ஆதரவு வேண்டும் என்று முடிவுக்கு வந்தோம். தொடர் ஆதரவு அந்த பெண்களின் சமுக வலையில் இல்லாத நபராக, பிரசவத்திற்கு ஆதரவு கொடுப்பதில் அனுபவமுள்ள, மிதமான அளவாவது அதற்கென்றே பயிற்சிபெற்ற நபரால் வழங்கும் போது மிகவும் பயனுள்ளதாக இருக்கும் என்று தோன்றுகிறது. தேர்வு செய்யப்பட்ட குடும்ப உறுப்பினர் அல்லது நண்பர் பிரசவத்தின் போது துணையாக, இருப்பதை அவ்வாறு ஒரு துணை இல்லாததுடன் ஒப்பிடுகையில் பெண்களுக்கு, தங்கள் குழந்தைபேறு அனுபவத்தின் திருப்தியை அதிகரிக்கிறது என தோன்றுகிறது.

மொழிபெயர்ப்பு குறிப்புகள்

மொழிபெயர்ப்பு: க. அழகுமூர்த்தி மற்றம் சி.இ.ப.ஏன்.அர் குழு

Laienverständliche Zusammenfassung

Kontinuierliche unterstützende Betreuung für Frauen während des Geburtsprozesses

Die kontinuierliche Betreuung während des Geburtsprozesses erhöhte die Wahrscheinlichkeit einer spontanen vaginalen Geburt, zeigte keine schädliche Wirkung und die Frauen waren zufriedener.

Geschichtlich betrachtet wurden Frauen während der Wehen des Geburtsprozesses schon immer von anderen Frauen begleitet und unterstützt. In vielen Ländern ist eine kontinuierliche Betreuung während des Geburtsprozesses jedoch zur Ausnahme statt zur Regel geworden, da mehr Frauen ihr Kind im Krankenhaus statt zu Hause gebären. Dies könnte zur Technisierung der Geburtserfahrungen von Frauen beitragen. Moderne geburtshilfliche Betreuung setzt Frauen häufig institutionellen Routinen aus, welche möglicherweise negative Auswirkungen auf den Geburtsprozess haben. Unterstützende Betreuung während des Geburtsprozesses kann emotionale Unterstützung, Maßnahmen zum Wohlbefinden, Informationen und Fürsprache für die Frau beinhalten. Diese Aktivitäten können die physiologischen Geburtsprozesse sowie das Gefühl der Frau, die Kontrolle zu behalten und kompetent zu sein, verbessern und somit die Notwendigkeit von geburtshilflichen Interventionen verringern. Der Review beinhaltet 23 Studien (22 enthielten Daten) aus 16 Ländern mit mehr als 15.000 Frauen, aus sehr unterschiedlichen Einrichtungen und Situationen. Die kontinuierliche Betreuung wurde entweder vom Krankenhauspersonal (z.B. Krankenschwestern oder Hebammen) geleistet, von Frauen, die nicht zum Krankenhauspersonal gehörten und keine persönliche Beziehung zu der gebärenden Frau hatten (z.B. Doulas oder Frauen, die einen gewissen Leitfaden zur Betreuung hatten), oder von einer Begleitung der Frau, die sie selbst aus ihrem sozialen Netzwerk gewählt hatte (z.B. der Ehemann, der Partner, die Mutter oder Freundin). Für Frauen, die eine kontinuierliche Geburtsunterstützung erhielten, war es wahrscheinlicher „spontan“ zu gebären, das heißt ohne Kaiserschnitt und ohne Saugglocke oder Zange. Außerdem hatten diese Frauen eine geringere Wahrscheinlichkeit, eine Schmerzmedikation in Anspruch zu nehmen und eine höhere Wahrscheinlichkeit zufrieden zu sein; darüber hinaus hatten sie geringfügig kürzere Geburten. Ihre Säuglinge hatten eine geringere Wahrscheinlichkeit, einen niedrigen 5-Minuten-Apgar Score zu haben. Es wurden keine unerwünschten Wirkungen festgestellt. Wir schlussfolgern, dass alle Frauen eine kontinuierliche Betreuung während des Geburtsprozesses haben sollten. Eine kontinuierliche Betreuung durch eine Person, die ausschließlich zur Unterstützung der Frau anwesend ist, kein Mitglied des sozialen Netzwerks der Frau ist und Erfahrung und Übung in der Geburtsbegleitung hat, scheint am nützlichsten zu sein. Im Vergleich zu keiner Begleitung während des Geburtsprozesses scheint die Unterstützung durch ein ausgewähltes Familienmitglied oder einen Freund die Zufriedenheit der Frauen bezüglich ihrer Geburtserfahrung zu erhöhen.

Anmerkungen zur Übersetzung

N. Peterwerth, freigegeben durch Cochrane Deutschland.

平易な要約

出産時の女性に対する継続的な支援

分娩時の継続的サポートは自然経膣分娩の機会を増加させ、危険性は認められず、満足度も高い。

歴史的に、陣痛・娩出時には他の女性が付き添い、介助を行ってきた。しかし、多くの国では自宅ではなく病院で出産する女性が多いため、分娩時の継続的サポートは一般的ではなく、特別な場合にのみ行われるようになった。これは、女性の出産経験における人間性の喪失に寄与している可能性がある。現代の産科ケアでは、多くの場合医療施設で定められた診療を一律に行うため、分娩進行に対する有害作用が認められる場合がある。分娩時のサポートケアには精神的サポート、安楽法、情報およびアドボカシーなどが含まれる。これらは生理的分娩過程を促進すると同時に女性の制御感や有能感も促進するため、産科介入の必要性が減少する。本レビューでは、16ヵ国から15,000例を超える女性が様々な背景や環境下で参加した23件の試験(22件のデータ)を対象とした。継続的サポートは、病院職員(看護師または助産師など)、病院職員ではなく分娩者と個人的な面識のない女性(ドゥーラまたは適切な指導を受けた女性など)、または分娩者が知り合いの中から選出した仲間(夫、パートナー、母親または友人など)が提供した。分娩時に継続的サポートを受けた女性は、「自然に」分娩する確率、すなわち帝王切開や吸引分娩、鉗子分娩を実施しない確率が高かった。さらに、鎮痛剤の使用率も低く、満足度が高く、分娩時間がわずかに短縮した。娩出された新生児は、5分アプガースコアが低値を示す確率が低かった。有害作用は認められなかった。結論として、すべての女性が分娩時に継続的サポートを受けるべきである。分娩者の知人ではなく、分娩時のサポート提供経験があり、少なくともある程度の訓練を受けた、サポート提供のみを行う人物による継続的サポートは、最も有益性が高いと考えられる。家族または友人の中から選出した人によるサポートは、分娩時に付き添い者がいない場合と比較して出産経験に対する分娩者の満足度を増加させると考えられる。

訳注

《実施組織》厚生労働省「「統合医療」に係る情報発信等推進事業」(eJIM:http://www.ejim.ncgg.go.jp/)[2015.12.29]《注意》この日本語訳は、臨床医、疫学研究者などによる翻訳のチェックを受けて公開していますが、訳語の間違いなどお気づきの点がございましたら、eJIM事務局までご連絡ください。なお、2013年6月からコクラン・ライブラリーのNew review, Updated reviewとも日単位で更新されています。eJIMでは最新版の日本語訳を掲載するよう努めておりますが、タイム・ラグが生じている場合もあります。ご利用に際しては、最新版(英語版)の内容をご確認ください。

Ringkasan bahasa mudah

Sokongan berterusan bagi wanita semasa bersalin

Sokongan berterusan dalam proses bersalin telah meningkatkan peluang kelahiran faraj secara spontan, adalah tidak merbahaya, dan wanita berasa lebih puas hati.

Dari segi sejarah wanita telah dbantu dan disokong oleh wanita lain semasa proses bersalin dan kelahiran bayi. Walaubagaimanapun di banyak negara, di mana lebih ramai wanita melahirkan bayi di hospital berbanding di rumah, sokongan berterusan semasa proses bersalin telah menjadi sesuatu kecualian dan bukan lagi menjadi kebiasaan. Ini boleh menyumbang kepada penyahmanusiaan pengalaman wanita yang bersalin. Penjagaan obstetrik moden seringkali mendedahkan wanita kepada rutin sesebuah institusi, yang mungkin mempunyai kesan buruk ke atas kemajuan proses bersalin. Penjagaan sokongan ketika proses bersalin mungkin melibatkan sokongan emosi, langkah-langkah keselesaan, informasi dan 'advocacy' (pembelaan / sokongan). Kesemua ini mungkin dapat memperbaiki fisiologi proses bersalin dan juga perasaan wanita dari segi kawalan dan keupayaan mereka, dan seterusnya mengurangkan keperluan intervensi obstetric. Ulasan kajian merangkumi 23 kajian (22 mengemukakan data), daripada 16 negara, melibatkan lebih dari 15,000 wanita dalam pelbagai persekitaran dan situasi. Sokongan berterusan telah diberikan oleh samada kakitangan hospital (seperti jururawat ataupun bidan), wanita yang bukan kakitangan hospital dan tidak mempunyai hubungan personal dengan wanita yang akan melahirkan bayi (seperti ‘doula’ atau wanita yang telah diberi petunjuk yang sederhana), atau rakan yang dipilih oleh wanita dari rangkaian sosialnya (seperti suami, teman, ibu ataupun kawan). Wanita yang menerima sokongan berterusan dalam proses bersalin adalah lebih berkemungkinan untuk melahirkan bayi secara spontan, iaitu, melahirkan bayi bukan secara ‘caesarean’ ataupun vakum ataupun ‘forceps’. Tambahan pula, wanita kurang berkemungkinan menggunakan ubatan tahan sakit, berasa lebih puas, dan menghadapi jangkamasa yang lebih singkat dalam proses bersalin. Bayi mereka kurang kemungkinanan untuk memiliki skor Apgar lima-minit yang rendah. Tiada kesan buruk telah dikenal pasti. Kami membuat kesimpulan bahawa semua wanita seharusnya mendapat sokongan berterusan semasa bersalin. Sokongan berterusan daripada seseorang yang hadir semata-mata untuk memberikan sokongan, bukan ahli rangkaian sosial wanita tersebut, berpengalaman dalam menyediakan sokongan semasa bersalin, dan mempunyai sekurang-kurangnya sejumlah latihan yang sederhana, muncul sebagai yang paling bermanfaat. Berbanding dengan tidak mempunyai teman ketika proses bersalin , sokongan daripada ahli keluarga yang dipilih ataupun rakan dapat menambahkan kepuasan wanita dalam pengalaman mereka semasa melahirkan bayi.

Catatan terjemahan

Diterjemahkan oleh Nila Pillai (Penang Medical College) Disunting oleh Tan May Loong (Penang Medical College). Untuk sebarang pertanyaan berkaitan terjemahan ini sila hubungi nila@pmc.edu.my

Background

The first version of this Cochrane review was published in 1995 (Hodnett 2003), when the first systematic reviews in The Cochrane Collaboration Pregnancy and Childbirth Group Module were converted to the Cochrane review format. Thus, a formal Cochrane protocol was not initially published. Subsequently, the review author, Ellen Hodnett, completed a trial of labour support (Hodnett 2002) with a sample size larger than the entire sample in the prior version of the original review. As a protection against bias, she sought co-authors who were blind to the results of the new trial and who had special expertise that would enhance the quality of the review. Discussions among the authors led to decisions to modify the background and methods. The authors decided that the best approach would be to write a new protocol for the review. The new protocol was submitted through the peer review process of the Cochrane Pregnancy and Childbirth Group and has subsequently evolved into a review that has been updated.

Historically and cross-culturally, women have been attended and supported by other women during labour and birth. However, since the middle of the 20th century, in many countries as the majority of women gave birth in hospital rather than at home, continuous support during labour has become the exception rather than the routine. Concerns about dehumanisation of women's birth experiences (in high-, middle-, and low-income countries) have led to calls for a return to continuous, one-to-one support by women for women during labour (Klaus 2002). Common elements of this care include emotional support (continuous presence, reassurance and praise), information about labour progress and advice regarding coping techniques, comfort measures (such as comforting touch, massage, warm baths/showers, promoting adequate fluid intake and output) and advocacy (helping the woman articulate her wishes to others).

Two complementary theoretical explanations have been offered for the effects of labour support on childbirth outcomes. Both explanations hypothesise that labour support enhances labour physiology and mothers' feelings of control and competence, reducing reliance on medical interventions. The first theoretical explanation considers possible mechanisms when companionship during labour is used in stressful, threatening and disempowering clinical birth environments (Hofmeyr 1991). During labour, women may be uniquely vulnerable to environmental influences; modern obstetric care frequently subjects women to institutional routines, high rates of intervention, unfamiliar personnel, lack of privacy and other conditions that may be experienced as harsh. These conditions may have an adverse effect on the progress of labour and on the development of feelings of competence and confidence; this may in turn impair adjustment to parenthood and establishment of breastfeeding, and increase the risk of depression. The provision of support and companionship during labour may to some extent buffer such stressors.

The second theoretical explanation does not focus on a particular type of birth environment. Rather, it describes two pathways - enhanced passage of the fetus through the pelvis and soft tissues, as well as decreased stress response - by which labour support may reduce the likelihood of operative birth and subsequent complications, and enhance women's feelings of control and satisfaction with their childbirth experiences (Hodnett 2002a). Enhanced fetopelvic relationships may be accomplished by encouraging mobility and effective use of gravity, supporting women to assume their preferred positions and recommending specific positions for specific situations. Studies of the relationships among fear and anxiety, the stress response and pregnancy complications have shown that anxiety during labour is associated with high levels of the stress hormone epinephrine in the blood, which may in turn lead to abnormal fetal heart rate patterns in labour, decreased uterine contractility, a longer active labour phase with regular well-established contractions and low Apgar scores (Lederman 1978; Lederman 1981). Emotional support, information and advice, comfort measures and advocacy may reduce anxiety and fear and associated adverse effects during labour.

Continuous support has been viewed by some as a form of pain relief, specifically, as an alternative to epidural analgesia (Dickinson 2002), because of concerns about the deleterious effects of epidural analgesia, including on labour progress (Anim-Somuah 2011). Many labour and birth interventions routinely involve, or increase the likelihood of, co-interventions to monitor, prevent or treat adverse effects, in a "cascade of interventions". Continuous, one-to-one support has the potential to limit this cascade and therefore, to have a broad range of different effects, in comparison to usual care. For example, if continuous support leads to reduced use of epidural analgesia, it may in turn involve less use of electronic fetal monitoring, intravenous drips, synthetic oxytocin, drugs to combat hypotension, bladder catheterisation, vacuum extraction or forceps, episiotomy and less morbidity associated with these, and may increase mobility during labour and spontaneous birth (Caton 2002).

A systematic review examining factors associated with women's satisfaction with the childbirth experience suggests that continuous support can make a substantial contribution to this satisfaction. When women evaluate their experience, four factors predominate: the amount of support from caregivers, the quality of relationships with caregivers, being involved with decision-making and having high expectations or having experiences that exceed expectations (Hodnett 2002a).

Clarification of the effects of continuous support during labour, overall and within specific circumstances, is important in light of public and social policies and programs that encourage this type of care. For example, the Congress in Uruguay passed a law in 2001 decreeing that all women have the right to companionship during labour. In several low- and middle-income countries (including China, South Africa, Tanzania and Zimbabwe); the Better Births Initiative promotes labour companionship as a core element of care for improving maternal and infant health (WHO 2010). In many low-income countries, women are not permitted to have anyone with them during labour and birth. Efforts to change policies in these settings have led to questions about the effectiveness of support from husbands/partners or other support people of the woman's own choosing, particularly in settings where the cost of paid companions would be prohibitive.

In North America, the services of women with special training in labour support have become available. Most commonly known as doula (a Greek word for 'handmaiden'), this new member of the caregiver team may also be called a labour companion, birth companion, labour support specialist, labour assistant or birth assistant. A number of North American organisations offer doula training, certification and professional support; according to one estimate more than 50,000 people have received this training to date (P Simkin, personal communication). Some North American hospitals have begun to sponsor doula services. In recent national surveys of childbearing women in the United States, 3% to 5% of respondents indicated that they had used doula services during their most recent labours (Declercq 2002; Declercq 2006). An association for doulas has been established in the UK (McGinnis 2001). Maternal healthcare systems in dozens of high- and low- to middle-income countries throughout the world are developing new traditions for supportive female companionship during labour (Pascali-Bonaro 2010).

Questions have arisen about the ability of employees (such as nurses or midwives) to provide effective labour support, in the context of modern institutional birth environments (Hodnett 1997). For example, nurses and midwives often have simultaneous responsibility for more than one labouring woman, spend a large proportion of time managing technology and keeping records, and begin or end work shifts in the middle of women's labours. They may lack labour support skills or may work in short-staffed environments.

Companions from a woman's social network, such as husbands/partners and female relatives, usually have little experience in providing labour support and are themselves in need of support when with a loved one during labour and birth. As they are frequently available to assume the role, often without extra cost to families or health systems, it is important to understand their effectiveness as providers of continuous labour support.

In addition to questions about the impact of the type of provider of labour support, there are other questions about the effectiveness of support, including its impact under a variety of environmental conditions, and whether its effects are mediated by when continuous support begins (early versus active labour).

Childbearing women, policy-makers, payers of health services, health professionals and facilities and those who provide labour support all need evidence about the effects of continuous support, overall and under specific conditions.

Objectives

The primary objective was to assess the effects, on mothers and their babies, of continuous, one-to-one intrapartum support compared with usual care, in any setting. Secondary objectives were to determine whether the effects of continuous support are influenced by the following.

  1. Routine practices and policies in the birth environment that may affect a woman's autonomy, freedom of movement and ability to cope with labour, including:

    1. policies about the presence of support people of the woman's own choosing;

    2. epidural analgesia; and

    3. continuous electronic fetal monitoring.

  2. Whether the provider is:

    1. a member of the staff of the institution (and thus has additional loyalties or responsibilities);

    2. not a staff member but not part of the woman's social network and present solely for the purpose of providing continuous support; or

    3. a person chosen by the woman from family members and friends.

  3. Whether the continuous support begins early or later in labour.

Methods

Criteria for considering studies for this review

Types of studies

All controlled trials comparing continuous labour support by either a familiar or unfamiliar person (with or without healthcare professional qualifications) with usual care, in which there was random allocation to treatment and control groups, were considered for inclusion in the review.

Types of participants

Pregnant women, in labour.

Types of interventions

The form of care that was evaluated was continuous presence and support during labour and birth. The person providing the support could have qualifications as a healthcare professional (nurse, midwife) or training as a doula or childbirth educator, or be a family member, spouse/partner, friend or stranger with little or no special training in labour support. The control group received usual care, as defined by the trialists. In all cases, 'usual care' did not involve continuous intrapartum support, but it could involve other measures, such as routine epidural analgesia, to help women to cope with labour.

Types of outcome measures

Theoretically, continuous support can have many diverse physiological and psychosocial effects (both short- and long-term), and therefore, a larger than usual number of outcomes were considered.

Primary outcomes
Mother
  1. Any analgesia/anaesthesia (pain medication).

  2. Synthetic oxytocin during labour.

  3. Spontaneous vaginal birth.

  4. Postpartum depression (defined using a pre-specified cutoff score on a validated instrument).

  5. Negative rating of/negative feelings about the birth experience.

Baby
  1. Admission to special care nursery.

  2. Breastfeeding at one to two months postpartum.

Secondary outcomes
Labour events
  1. Regional analgesia/anaesthesia.

  2. Labour length

  3. Severe labour pain (postpartum report).

Birth
  1. Caesarean birth.

  2. Instrumental vaginal birth.

  3. Perineal trauma (defined as episiotomy or laceration requiring suturing).

Newborn

  1. Low five-minute Apgar score (as defined by trial authors).

  2. Prolonged newborn hospital stay.

Longer-term maternal outcomes
  1. Difficulty mothering.

  2. Low self-esteem in the postpartum period.

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 (31 May 2013). 

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

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

  2. weekly searches of MEDLINE;

  3. weekly searches of 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.  

We did not apply any language restrictions.

Data collection and analysis

For this update we assessed one new trial (Yuenyong 2012) and added 'postpartum depression' outcome data from one existing trial report (Hofmeyr 1991), using the following methods.

Selection of studies

For the current update, three review authors (E Hodnett, J Hofmeyr, C Sakala) independently assessed for inclusion all potentially eligible studies. Had any disagreement occurred, we would have resolved it through discussion or, if required, we would have consulted a third member of the review team.

Data extraction and management

We designed a form to extract data. For eligible studies, data were independently extracted by two people (either two review authors or an author and an assistant), using the agreed form. We resolved discrepancies through discussion. We entered data into Review Manager software (RevMan 2011) and checked for accuracy.

When information regarding any of the above was unclear, we attempted to contact authors of the original reports to provide further details.

Assessment of risk of bias in included studies

For each study, at least two review authors independently assessed risk of bias, using the criteria outlined in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). We would have resolved any disagreement by discussion or by involving a third assessor.

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

We described for each included study the method used to generate the allocation sequence in sufficient detail to allow an assessment of whether it should 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 described for each included study the method used to conceal the allocation sequence, and determined whether intervention 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 and detection bias)

We described for each included study the methods used, if any, to blind personnel from knowledge of which intervention a participant received. Since women and care providers cannot be blinded as to whether continuous support was given, we considered blinding adequate if outcomes were recorded by outcome assessors who had no knowledge of the woman's group assignment. We judged studies at low risk of bias if they were blinded, or if we judged that the lack of blinding could not have affected the results. We assessed blinding separately for different outcomes or classes of outcomes.

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

We described for each included study, and for each outcome or class of outcomes, the completeness of data including attrition and exclusions from the analysis. We stated whether attrition and exclusions were 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. To be included in the review, data on a given outcome had to be available for at least 80% of those who were originally randomised. For outcomes collected post-hospital discharge, we recognise that follow-up, particularly in low-income countries, can be very difficult. Therefore, we included data if the response rate was higher than 75% and there was no obvious imbalance in groups. Where sufficient information was reported, or could be supplied by the trial authors, we planned to include missing data in the analyses. We assessed methods as:

  • low risk of bias;

  • high risk of bias;

  • unclear risk of bias.

(5) Selective reporting bias

We described for each included study how we investigated the possibility of selective outcome reporting bias and what we found.

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 fails 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 planned to describe for each included study any important concerns we had about other possible sources of bias, including, for example, whether the trial was stopped early due to a data-dependent process, there was evidence of extreme baseline imbalance, or there had been claims of fraud.

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

  • low risk of other bias;

  • high risk of other bias;

  • unclear whether there is risk of other bias.

(7) Overall risk of bias

We 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 is likely to impact on the findings. We explored the impact of the level of bias through undertaking sensitivity analyses - see Sensitivity analysis.

Measures of treatment effect

Dichotomous data

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

Continuous data

All but one pre-specified outcome involved dichotomous data. For labour length, we used the mean difference because it was measured in the same way in the trials.  

Unit of analysis issues

Cluster-randomised trials

Had we found cluster-randomised trials, we would have included them in the analyses along with individually-randomised trials. Our plan was as follows: we would adjust their sample sizes or standard errors using the methods described in the Handbook (Section 16.3.4 or 16.3.6) using an estimate of the intracluster correlation co-efficient (ICC) derived from the trial (if possible), from a similar trial or from a study of a similar population. If we had used ICCs from other sources, we planned to report this and conduct sensitivity analyses to investigate the effect of variation in the ICC. In future updates of this review, if we identify both cluster-randomised trials and individually-randomised trials, we plan to synthesise the relevant information. We will consider it reasonable to combine the results from both if there is little heterogeneity between the study designs and the interaction between the effect of intervention and the choice of randomisation unit is considered to be unlikely. We will also acknowledge heterogeneity in the randomisation unit and perform a separate meta-analysis.

Dealing with missing data

For included studies, we noted levels of attrition. We included data for a given outcome which occurred prior to hospital discharge only if the data were available for at least 80% of those originally randomised. For outcomes collected post-hospital discharge we included data if the response rate was higher than 75% and there was no obvious imbalance in groups.

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. The denominator for each outcome in each trial was the number randomised minus any participants whose outcomes were known to be missing.

Assessment of heterogeneity

We assessed statistical heterogeneity in each meta-analysis using the T², I² and Chi² statistics. We regarded heterogeneity as substantial if the T² was greater than zero and either the I² was greater than 30% or there was a low P value (less than 0.10) in the Chi² test for heterogeneity. In such cases we took the following steps:

  1. a sensitivity analysis, in which methodological weak trials were removed from the analyses and results compared for the primary outcomes;

  2. visual inspection of the forest plots for evidence of inconsistency in results; and

  3. comparison of the results of fixed-effect and random-effects analyses.

Assessment of reporting biases

Had we suspected reporting bias, we would have attempted to contact study authors asking them to provide missing outcome data. If this were not possible, and the missing data were thought to introduce serious bias, we would not have included the outcome data from that trial

Data synthesis

We carried out statistical analysis using the Review Manager software (RevMan 2011). We used fixed-effect Mantel-Haenszel meta-analysis for combining data in the absence of heterogeneity, and random-effects analysis if substantial heterogeneity was detected and we considered that combining trials was meaningful. We defined heterogeneity as substantial if a given meta-analysis resulted in an I² value greater than 30%, and there was inconsistency among trials in the direction or magnitude of effects (judged visually in the forest plot), or a low (less than 0.10) P value in the Chi² test for heterogeneity.

Subgroup analysis and investigation of heterogeneity

We planned the following subgroup analyses. 

A) Three subgroup analyses that concern characteristics of the childbirth environment
  • Trials in settings in which women were permitted to be accompanied by one or more support persons of their own choosing compared with trials in which accompaniment was not permitted.

  • Trials conducted in settings in which epidural analgesia was available compared with trials in settings in which it was unavailable.

  • Trials in which there was a policy of routine electronic fetal heart rate monitoring compared with trials in settings in which continuous electronic fetal monitoring was not routine.

(B) One subgroup analysis that concerns characteristics of the providers of labour support
  • Trials in which the caregivers were employees of the institution, compared with trials in which the caregivers were not employees and were not members of the woman's social network, compared with trials in which the providers were not employees and were lay people chosen by the participants (e.g. husband/partner, friend, close relative).

(C) One subgroup analysis that concerns differences in the timing of onset of continuous support
  • Trials in which continuous labour support began prior to or during early labour (as defined by trial authors), compared with trials in which continuous support began in active labour.

Because few of the trial reports contained all of the information needed for the above subgroup analyses, we contacted the trial authors in an attempt to verify the presence/absence of routine electronic fetal monitoring (EFM), the presence/absence of epidural analgesia and timing of onset of continuous support. We excluded some studies included in the primary comparisons from the subgroup analyses concerning the use of EFM because their status regarding EFM use was unknown. For tests of differences between these subgroups, we recalculated the overall analysis by including only the studies in which EFM use was known.

The seven primary outcomes and one secondary outcome were used in the subgroup analyses. While normally, subgroup analyses are restricted to primary outcomes, we also included the outcome of caesarean delivery, because there is widespread concern about escalating caesarean rates worldwide, and subgroup analyses could be helpful to policy makers in decisions about the provision of continuous labour support. Thus the outcomes in the subgroup analyses were: any analgesia/anaesthesia, synthetic oxytocin during labour, spontaneous vaginal birth, caesarean birth, postpartum depression, negative ratings of the birth experience, admission to special care nursery, and breastfeeding at one to two months postpartum.

When I² levels were high but the amount of heterogeneity in treatment effects was low (as happens when there are a large number of big trials and thus the amount of variation due to sampling error is extremely low), we compared the results of random-effects and fixed-effect analyses. In instances in which the conclusions were not materially different in both methods of analysis, we reported the results of fixed-effect, inverse variance meta-analysis, in order to be able to calculate a Chi² for the purpose of exploring differences based on pre-specified subgroups. As a consequence the totals in the subgroup analysis tables are sometimes slightly different from those in the main comparison, since the main comparisons used the Mantel-Haenszel rather than the inverse variance method.

Sensitivity analysis

We performed sensitivity analyses, for the primary outcomes, in instances in which there was a high risk of bias associated with the quality of included trials.

Results

Description of studies

Included studies

Please see Characteristics of included studies table. While 23 trials met the inclusion criteria, one trial (Thomassen 2003) provided no usable outcome data. We do not describe it here, but provide details in the Characteristics of included studies table.

All 22 trials (n = 15,288) that provided usable outcome data were conducted in hospitals. The trials were conducted in Australia, Belgium, Botswana, Brazil, Canada, Chile, Finland, France, Greece, Guatemala, Mexico, Nigeria, South Africa, Sweden, Thailand, and the United States, under widely disparate hospital conditions, regulations and routines. There was remarkable consistency in the descriptions of continuous support across all trials. In all instances the intervention included continuous or nearly continuous presence, at least during active labour. Twenty of the 22 trials that provided usable outcome data (all except Cogan 1988 and Dickinson 2002) also included specific mention of comforting touch and words of praise and encouragement.

In 11 trials (Breart - Belgium 1992; Breart - France 1992; Campbell 2006; Cogan 1988; Dickinson 2002; Gagnon 1997; Hemminki 1990a; Hemminki 1990b; Hodnett 1989; Hodnett 2002; McGrath 2008), hospital policy permitted women to be accompanied by their husbands/partners or other family members during labour, while in the other 11 trials, no additional support people were allowed. Epidural analgesia was not routinely available in seven trials (Breart - Greece 1992; Hofmeyr 1991; Kashanian 2010; Klaus 1986; Madi 1999; Morhason-Bello 2009; Yuenyong 2012). We were unsuccessful in obtaining information about the availability of epidural analgesia in one trial (Cogan 1988). Epidural analgesia was routinely available in the other 14 trials. Electronic fetal heart rate monitoring was not routine in eight trials (Bruggemann 2007; Hofmeyr 1991; Kashanian 2010; Klaus 1986; Langer 1998; Madi 1999; Morhason-Bello 2009; Yuenyong 2012). In nine trials (Campbell 2006; Dickinson 2002; Gagnon 1997; Hemminki 1990a; Hemminki 1990b; Hodnett 1989; Hodnett 2002; Kennell 1991; McGrath 2008) electronic fetal monitoring was used routinely. We were unsuccessful in obtaining information about the use of electronic fetal monitoring in five trials (Breart - Greece 1992; Breart - Belgium 1992; Breart - France 1992; Cogan 1988; Torres 1999).

It was not possible to categorise most of the trials according to the pre-specified subgroups of early versus active labour. In four trials (Cogan 1988; Hodnett 1989; Klaus 1986; Madi 1999), the support began in early labour. In the other 17 trials, the timing of onset of support was much more heterogenous, as were definitions of early and active labour, in instances in which these were defined. Women were in varying phases of labour, from elective induction to active labour.

In addition, the persons providing the support intervention varied in their experience, qualifications and relationship to the labouring women. In nine trials (Breart - Belgium 1992; Breart - France 1992; Breart - Greece 1992; Dickinson 2002; Gagnon 1997; Hemminki 1990a; Hemminki 1990b; Hodnett 2002; Kashanian 2010), the support was provided by a member of the hospital staff, for example, a midwife, student midwife or nurse. In seven trials the providers were not members of the hospital staff and were not part of the woman's social network; they were women with or without special training, such as doulas or women who had given birth before (Hodnett 1989; Hofmeyr 1991; Kennell 1991; Klaus 1986; McGrath 1999): a childbirth educator (Cogan 1988), or retired nurses (Langer 1998). In six trials they were companions of the woman's choice from her social network, with or without brief training -- a female relative or friend or the woman's husband/partner (Bruggemann 2007; Campbell 2006; Madi 1999; Morhason-Bello 2009; Torres 1999; Yuenyong 2012).

Excluded studies

Sixteen trials were excluded altogether (Bender 1968; Bochain 2000; Brown 2007; Dalal 2006; Gordon 1999; Hemminki 1990c; Lindow 1998; McGrath 1999; Orenstein 1998; Pinheiro 1996; Ran 2005; Scott 1999; Sosa 1980; Trueba 2000; Tryon 1966; Zhang 1996). Seven trials were excluded as they were not randomised trials (Bender 1968; Dalal 2006; Ran 2005; Scott 1999; Sosa 1980; Trueba 2000; Tryon 1966). Five trials were excluded because the intervention was not continuous support (Bochain 2000; Brown 2007; Lindow 1998; Orenstein 1998; Zhang 1996). Two trials reported as abstracts provided insufficient information in order to assess eligibility (McGrath 1999; Pinheiro 1996). Two further trials were excluded because they did not provide any usable data (Gordon 1999; Hemminki 1990c). Please refer to table Characteristics of excluded studies for details.

Risk of bias in included studies

The trials were of generally good quality (Figure 1; Figure 2).

Figure 1.

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

Figure 2.

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies

Allocation

Random sequence generation: Twelve trials were at unclear risk of bias (Breart - Belgium 1992; Breart - France 1992; Breart - Greece 1992; Cogan 1988; Dickinson 2002; Hemminki 1990a; Hemminki 1990b; Kennell 1991; Klaus 1986; Madi 1999; McGrath 2008; Thomassen 2003) because they did not describe the method of random assignment. Eleven trials described using a computer random number generator or referred to a random number table (Bruggemann 2007; Campbell 2006; Gagnon 1997; Hodnett 1989; Hodnett 2002; Hofmeyr 1991; Kashanian 2010; Langer 1998; Morhason-Bello 2009; Torres 1999; Yuenyong 2012) and were assessed as low risk of bias.

Allocation concealment: The risk of selection bias was high in two small trials (Bruggemann 2007; Kashanian 2010). In Bruggemann 2007, women picked their treatment allocation from an opaque container. In 11 trials (Campbell 2006; Gagnon 1997; Hodnett 1989; Hodnett 2002; Kennell 1991; Klaus 1986; Madi 1999; McGrath 2008; Morhason-Bello 2009; Torres 1999; Yuenyong 2012), risk of selection bias was low with allocation described as either using central allocation, e.g. Hodnett 2002 used a central, computerised randomisation service accessed by telephone or other trials described using sequentially numbered, opaque, sealed envelopes. In the remaining trials (Breart - Belgium 1992; Breart - France 1992; Breart - Greece 1992; Cogan 1988; Dickinson 2002; Hemminki 1990a; Hemminki 1990b; Hofmeyr 1991; Langer 1998; Thomassen 2003), risk of selection bias was unclear, e.g. one trial used methods that were centrally controlled but not concealed (Cogan 1988).

Blinding

Performance bias: neither those providing nor receiving care could be blinded to the presence/absence of a person providing continuous support. Hodnett 2002 provided evidence to discount contamination and co-intervention as serious threats to validity. In eight trials group assignment was known and no attempt to blind outcome assessment was apparent and so these were assessed as being at high risk of bias (Bruggemann 2007; Campbell 2006; Gagnon 1997; Hemminki 1990a; Hemminki 1990b; Hofmeyr 1991; Madi 1999; Morhason-Bello 2009).

Detection bias: in the trials which sought participants' evaluations of their birth experiences, efforts were made to reduce response bias, through use of an interviewer blinded to the woman's group allocation or self-administered questionnaires. Six trials were assessed as being at low risk of bias because some blinding of outcome assessment was performed (Cogan 1988; Hodnett 1989; Hodnett 2002; Kashanian 2010; Langer 1998; Yuenyong 2012).

In the remaining trials, risk of bias for blinding (performance and detection bias) was unclear (Breart - Belgium 1992; Breart - France 1992; Breart - Greece 1992; Dickinson 2002; Kennell 1991; Klaus 1986; McGrath 2008; Thomassen 2003; Torres 1999).

Incomplete outcome data

Attrition bias: we did not include data for outcomes assessed in hospital in a comparison if there was more than 20% loss to follow-up; we did not include longer-term outcome data if there was more than 25% loss to follow-up. Based on these criteria, one trial (Thomassen 2003) provided no usable outcome data. Two trials further trials were assessed as being at high risk of bias for attrition bias (Campbell 2006; Cogan 1988).

Selective reporting

All outcomes appear to have been reported upon in the majority of trials. In two trials, it was unclear whether selective reporting had taken place (Cogan 1988; Thomassen 2003).

Other potential sources of bias

Three trials were assessed as being at high risk of other bias: in two trials the mothers had been told the purpose of the study differentially (Hemminki 1990a; Hemminki 1990b) and one trial was stopped early for 'a range of largely organizational issues' when only a quarter of the original sample size had been enrolled (Thomassen 2003). Risk of bias was unclear in one study (Campbell 2006) and no other sources of bias were apparent in the remaining trials.

Effects of interventions

Main comparison: continuous support versus usual care - all trials

We considered 17 outcomes. Between one and 22 trials contributed to the analyses of each outcome. Sensitivity analyses, conducted by removing the trials (all of which were small) with a high likelihood of selection bias (Bruggemann 2007; Hodnett 1989; Kashanian 2010) did not alter the conclusions. According to our pre-specified criteria, there was statistical heterogeneity in all but three outcomes (instrumental vaginal birth, low five-minute Apgar score, and low postpartum self-esteem). Inspection of the forest plots did not suggest sources of heterogeneity. For the two outcomes postpartum depression and difficulty mothering, this statistical heterogeneity confirmed our conclusion that based on clinical heterogeneity a summary statistic would not yield meaningful results (discussed further below). In all instances in which summary statistics are reported, the comparisons of fixed-effect and random-effects analyses did not yield substantive differences, nor alter conclusions. We report the results of fixed-effect analyses for instrumental vaginal birth, low five-minute Apgar score, and low postpartum self-esteem (the latter only contained one trial), and random-effects analyses for all other outcomes in which summary statistics were computed.

Primary outcomes

Women who had continuous, one-to-one support during labour were:

more likely to have

  • a spontaneous vaginal birth (19 trials, n = 14,119, average risk ratio (RR) 1.08, 95% confidence interval (CI) 1.04 to 1.12, I² 45%, т² 0.00), Analysis 1.5;

less likely to have

  • any intrapartum analgesia/anaesthesia (14 trials, n = 12,283, average RR 0.90, 95% CI 0.84 to 0.96, I² 75%, т² 0.01), Analysis 1.1;

  • reported negative rating of/negative feelings about childbirth experience (11 trials, n = 11,133, average RR 0.69, 95% CI 0.59 to 0.79, I² 63%, т² 0.03), Analysis 1.13;

and there was no apparent impact of continuous support on

  • use of synthetic oxytocin during labour (15 trials, n = 12,620, average RR 0.97, 95% CI 0.91 to 1.04, I² 65%, т² 0.01), Analysis 1.3;

  • admission to the special care nursery (seven trials; n = 8897, average RR 0.97, 95% CI 0.76 to 1.25, I² 37%, т² 0.03), Analysis 1.10;

  • breastfeeding at one to two months postpartum (three trials, n = 5363, average RR 1.01, 95% CI 0.94 to 1.09, I² 52%, т² 0.00), Analysis 1.15; and

evidence of postpartum depression was a reported outcome in just two trials (Hodnett 2002; Hofmeyr 1991). Hodnett 2002 used the Edinburgh Postnatal Depression Inventory and reported the frequencies of scores greater than 12. Hofmeyr 1991 used the Pitt Depression Inventory and reported scores indicating mild (less than 20), moderate (20 to 34), and severe (greater than 34) depressive symptomatology. We combined the frequencies of moderate and severe depressive symptomatology, since Pitt scores greater than 19 have been considered indicative of postpartum depression (Avan 2010). The two trials were widely disparate in populations, the hospital conditions within which they were conducted, and the type of support provider. We concluded that combining them would not yield meaningful information. In both trials the direction of effect was the same. In Hofmeyr 1991, eight of 74 women in the group receiving continuous support had depressive symptomatology compared to 44 of 75 women in the control group; RR 0.18, 95% CI 0.09 to 0.36. In Hodnett 2002, 245 out of 2816 in the supported group had depressive symptomatology, compared to 277 out of 2751 in the control group; RR 0.86, 95% CI 0.73 to 1.02.

Secondary outcomes

Women who had continuous, one-to-one support were:

more likely to have

  • shorter labours (12 trials, n = 5366, mean difference (MD) -0.58 hours, 95% CI -0.85 to -0.31, I² 45%, т² 0.08), Analysis 1.4;

less likely to have

  • regional analgesia/anaesthesia (nine trials, n = 11,444, average RR 0.93, 95% CI 0.88 to 0.99, I² 81%, т² 0.01), Analysis 1.2;

  • an instrumental vaginal birth (19 trials, n = 14,118, RR 0.90, 95% CI 0.85 to 0.96, fixed-effect), Analysis 1.6;

  • a caesarean birth (22 trials, n = 15,175, average RR 0.78, 95% CI 0.67 to 0.91, I² 53%, т² 0.05), Analysis 1.7;

  • a baby with a low five-minute Apgar score (13 trials, n = 12,515, RR 0.69, 95% CI 0.50 to 0.95, fixed-effect), Analysis 1.9;

and there was no apparent impact of continuous labour support on

  • the likelihood of serious perineal trauma (four trials, n = 8120, average RR 0.97, 95% CI 0.92 to 1.01, I² 44%, т² 0.00), Analysis 1.8;

  • severe labour pain (four trials; n = 2456, average RR 1.00, 95% CI 0.83 to 1.21, I² 78%, т² 0.03), Analysis 1.12;

  • low postpartum self-esteem (one trial, n = 652, RR 1.00, 95% CI 0.77 to 1.30, fixed-effect), Analysis 1.17; and

  • prolonged neonatal hospital stay (three trials, n = 1098, average RR 0.83, 95% CI 0.42 to 1.65, I² 62%, т² 0.15), Analysis 1.11.

Three trials reported results related to difficulty in mothering (Campbell 2006; Hofmeyr 1991; Hodnett 2002). As was the case with postpartum depression, the trials were widely disparate in populations, the hospital conditions within which they were conducted, and the type of support provider, and the forest plot supported our conclusion that combining them would not yield meaningful information. In Hofmeyr 1991, 41 out of 75 in the continuous support group reported difficulty mothering, compared to 67 out of 75 in the control group; RR 0.61, 95% CI 0.49, 0.76. In Hodnett 2002, 873 out of 2836 in the continuous support group reported difficulty mothering, compared to 853 out of 2765 in the control group; RR 1.00, 95% CI 0.92, 1.08. In Campbell 2006, 11 out of 292 in the continuous support group reported difficulty mothering, compared to 38 out of 265 in the control group; RR 0.26, 95% CI 0.14, 0.50.

Subgroup comparisons

We grouped the trials according to the following provider characteristics: 1) staff members of the hospital; 2) neither hospital employees nor part of the woman's social network; and 3) chosen by the woman from her social network.

We have presented the results of the subgroup analyses below. While we made every effort to obtain the required information from trial authors, none of the subgroup comparisons are based on the total number of included trials for which usable data were available. Thus results must be interpreted with caution. The text below does not present the results for postpartum depression or breastfeeding at one to two months postpartum, because too few trials provided data. Only two trials contributed data about postpartum depression (Hodnett 2002; Hofmeyr 1991) and three about breastfeeding (Hodnett 2002; Hofmeyr 1991; Langer 1998).

We were unable to conduct the planned subgroup comparison based on timing of onset of labour support. It was not possible to categorise most of the trials according to the pre-specified subgroups of early versus active labour. In four trials (Cogan 1988; Hodnett 1989; Klaus 1986; Madi 1999), the support began in early labour. In the other 18 trials, both the definitions of early and active labour and the timing of onset of support were much more heterogenous, in instances in which they were defined. Women were in varying phases of labour, from elective induction to active labour.

As noted in Subgroup analysis and investigation of heterogeneity, totals in the subgroup analysis figures may differ slightly from those in the main comparisons, because a different method of analysis had to be used. All subgroup comparisons used fixed-effect, to allow computation of tests for differences between subgroups.

Outcome: any intrapartum analgesia/anaesthesia
  1. Policies about the presence of companions during labour and birth: In seven trials (n = 9752) companions were permitted; RR 0.97, 95% CI 0.96 to 0.99, while in seven trials (n = 2598) companions were not permitted; RR 0.91, 95% CI 0.85 to 0.96. Chi² for the subgroup comparison = 5.12, P = 0.02, Analysis 2.1.

  2. Availability of epidural analgesia: In nine trials (n = 10,888), epidural analgesia was routinely available; RR 0.97, 95% CI 0.96 to 0.98. In five trials (n = 1462) epidural analgesia was not routinely available; RR 0.83, 95% CI 0.69 to 0.99. Chi² for the subgroup comparison = 3.08, P = 0.08, Analysis 3.1.

  3. Routine use of electronic fetal monitoring (EFM): in six trials (n = 8580), EFM was routine; RR 0.97, 95% CI 0.96 to 0.99. In six trials (n = 2186), EFM was not routine; RR 0.96, 95% CI 0.90 to 1.02. In two trials (n = 1579), the policy about routine EFM was unknown; RR 0.89, 95% CI 0.80 to 0.99. Chi² for the subgroup comparison = 2.32, P = 0.31, Analysis 4.1.

  4. Provider characteristics: in six trials (n = 9152) the support was provided by a member of the hospital staff; RR 0.97, 95% CI 0.96 to 0.99. In four trials (n = 1790), the support was provided by a woman who was not a member of the staff and was not part of the woman's social network; RR 0.91, 95% CI 0.86 to 0.97. In four trials (n = 1408) the support was provided by a member of the woman's social network; RR 0.94, 95% CI 0.88 to 1.00. Chi² for the subgroup comparison = 4.84, P = 0.09, Analysis 5.1.

Thus, the effects of continuous support on use of any intrapartum analgesia/anaesthesia appeared to be stronger in settings where companions were not permitted, but did not appear to be influenced by the availability of epidural analgesia, the use of routine EFM, or provider characteristics.

Outcome: synthetic oxytocin during labour
  1. Policies about the presence of companions: in five trials (n = 9495) companions were permitted; RR 1.04, 95% CI 0.99 to 1.10. In 10 trials (n = 3125) companions were not permitted; RR 0.99, 95% CI 0.97 to 1.02. Chi² for the subgroup comparison = 3.13, P = 0.08, Analysis 2.2.

  2. Availability of epidural analgesia: in eight trials (n = 10,568) epidural analgesia was routinely available; RR 1.00, 95% CI 0.98 to 1.02. In seven trials (n = 2066), epidural analgesia was not routinely available; RR 1.02, 95% CI 0.93 to 1.11. Chi² for the subgroup comparison = 0.24, P = 0.63, Analysis 3.2.

  3. Use of routine EFM: in four trials (n = 8340) EFM was routine; RR 1.04, 95% CI 0.98 to 1.11. In seven trials (n = 1726) EFM was not routine; RR 0.99, 95% CI 0.96 to 1.01. In four trials (n = 2568) it is not known whether EFM was routine; RR 1.02, 95% CI 0.97 to 1.08. Chi² for the subgroup comparison = 3.27, P = 0.19, Analysis 4.2.

  4. Provider characteristics: in six trials (n = 9561), the support was provided by a member of the hospital staff; RR 1.06, 95% CI 1.01 to 1.11. In three trials (n = 1018), the support was provided by a woman who was not a member of the staff and was not part of the woman's social network; RR 0.69, 95% CI 0.50 to 0.94. In six trials (n = 2041), the support was provided by a member of the woman's social network; RR 0.99, 95% CI 0.96 to 1.01. Chi² for the subgroup comparison = 11.46, P = 0.003, Analysis 5.2.

Thus the effects of continuous support on use of synthetic oxytocin during labour did not appear to be influenced by policies about the presence of companions, use of routine EFM, or availability of epidural analgesia. The effectiveness of continuous support in reducing the likelihood of intrapartum oxytocin seemed to be strongest when the provider was neither a staff member nor part of the woman's social network.

Outcome: spontaneous vaginal birth
  1. Policies about companions: In nine trials (n = 10,889) companions were permitted; RR 1.03, 95% CI 1.00 to 1.05. In ten trials (n = 3329) companions were not permitted; RR1.11, 95% CI 1.07 to 1.16. Chi² for the subgroup comparison = 11.82, P < 0.001, Analysis 2.3.

  2. Availability of epidural analgesia: In 13 trials (n = 12,672), epidural analgesia was routinely available; RR 1.04, 95% CI 1.01 to 1.06). In six trials (n = 1546) epidural analgesia was not routinely available; RR 1.11, 95% CI 1.06 to 1.17. Chi² for the subgroup comparison = 6.59, P = 0.01, Analysis 3.3.

  3. Routine use of EFM: In eight trials (n = 9717) EFM was routine; RR 1.03, 95% CI 1.01 to 1.06. In seven trials (n = 1913) EFM was not routine; RR 1.11, 95% CI 1.06 to 1.17. In four trials (n = 2561), the policy about routine EFM is not known; RR 1.07, 95% CI 1.01 to 1.13. Chi² for the subgroup comparison = 8.56, P = 0.01, Analysis 4.3.

  4. Provider characteristics: in nine trials (n = 10,813) the support was provided by a member of the hospital staff; RR 1.03, 95% CI 1.01 to 1.06. In five trials (n = 1935) the support was provided by a woman who was not part of the hospital staff nor part of the woman's social network; RR 1.12, 95% CI 1.07 to 1.17. In five trials (n = 1470), the support was provided by a member of the woman's social network; RR 1.07, 95% CI 0.99 to 1.15. Chi² for the subgroup comparison = 9.97, P = 0.007, Analysis 5.3.

Thus the effectiveness of continuous support in increasing the likelihood of spontaneous vaginal birth appeared to be stronger when hospital policies did not permit companions, when epidural analgesia was not available, when EFM was not routine, and when the support provider was neither a staff member nor part of the woman's social network.

Outcome: caesarean birth
  1. Policies about companions: in 11 trials (n = 11,326) companions were permitted; RR 0.94, 95% CI 0.85 to 1.03. In 11 trials (n = 3849) companions were not permitted; RR 0.75, 95% CI 0.65 to 0.86. Chi² for the subgroup comparison = 6.46, P = 0.01, Analysis 2.4.

  2. Availability of epidural analgesia: in 14 trials (n = 13,064), epidural analgesia was routinely available; RR 0.93, 95% CI 0.86 to 1.02. In seven trials (n = 2077), epidural analgesia was not routinely available; RR 0.54, 95% CI 0.43 to 0.68. In one very small trial (n = 34), we were unable to determine if epidural analgesia was routinely available; RR 1.40, 95% CI 0.14 to 13.98. Chi² for the subgroup comparison = 19.30, P < 0.0001, Analysis 3.4.

  3. Routine use of EFM: in nine trials (n = 10,123), EFM was routine; RR 0.92, 95% CI 0.83 to 1.01. In eight trials (n = 2457) EFM was not routine; RR 0.66, 95% CI 0.55 to 0.79. In five trials (n = 2595), it is not known whether EFM was routine; RR 1.06, 95% CI 0.84 to 1.33. Chi² for the subgroup comparison = 12.78, P = 0.002, Analysis 4.4.

  4. Provider characteristics: in nine trials (n = 10,786), the support was provided by a member of the hospital staff; RR 0.95, 95% CI 0.85 to1.05. In seven trials (n = 2330), the support was provided by a woman who was not a member of the hospital staff and not part of the woman's social network; RR 0.72, 95% CI 0.60 to 0.86. In six trials (n = 2059), the support was provided by a member of the woman's social network; RR 0.83, 95% CI 0.69 to 1.01. Chi² for the subgroup comparison = 6.88, P = 0.03, Analysis 5.4.

Thus the effectiveness of continuous support in reducing the likelihood of caesarean birth appeared to be stronger in settings where companions were not permitted, epidural analgesia was not routinely available and EFM was not routine, and when the provider was neither a staff member nor part of the woman's social network.

Outcome: admission to special care nursery
  1. Policies about companions: in two trials (n = 7328), companions were permitted; RR 0.99, 95% CI 0.84 to 1.17. In five trials (n = 1569), companions were not permitted; RR 0.91, 95% CI 0.71 to 1.17. Chi² for the subgroup comparison = 0.28, P = 0.60, Analysis 2.5.

  2. Availability of epidural analgesia: in five trials (n = 8380) epidural analgesia was routinely available; RR 0.98, 95% CI 0.85 to 1.13. In two trials (n = 517) epidural analgesia was not routinely available; RR 0.26, 95% CI 0.08 to 0.88. Chi² for the subgroup comparison = 4.51, P = 0.03, Analysis 3.5.

  3. Routine use of EFM: in three trials (n = 7740) EFM was routine; RR 0.97, 95% CI 0.84 to 1.11. In three trials (n = 729) EFM was not routine; RR 0.48, 95% CI 0.21 to 1.12. In one trial (n = 428), it is not known whether EFM was routine; RR 1.98, 95% CI 0.76 to 5.18. Chi² for the subgroup comparison = 4.76, P = 0.09, Analysis 4.5.

  4. Provider characteristics: in three trials (n = 7428), the support was provided by a member of the hospital staff; RR 0.99, 95% CI 0.84, 1.17. In two trials (n = 829), the support was provided by a woman who was not a member of the hospital staff and not part of the woman's social network; RR 0.86, 95% CI 0.66 to 1.12. In two trials (n = 640) the support was provided by a member of the woman's social network; RR 1.40, 95% CI 0.67 to 2.93. Chi² for the subgroup comparison = 1.74, P = 0.42, Analysis 5.5.

Thus the effectiveness of continuous support in reducing the likelihood of admission of the newborn to a special care nursery appeared to be stronger in settings in which epidural analgesia was not routinely available, but effectiveness did not appear to be influenced by policies about companions or routine EFM, or by provider characteristics.

Outcome: negatives ratings of/negative views about the birth experience
  1. Policies about companions: in five trials (n = 8639) companions were permitted; RR 0.70, 95% CI 0.62 to 0.78. In six trials (n = 2539) companions were not permitted; RR 0.62, 95%CI 0.56 to 0.69. Chi² for the subgroup comparison = 2.03, P = 0.15, Analysis 2.7.

  2. Availability of epidural analgesia: in nine trials (n = 10,404) epidural analgesia was routinely available; RR 0.70, 95% CI 0.64 to 0.77. In two trials (n = 774) epidural analgesia was not routinely available; RR 0.55, 95% CI 0.48 to 0.63. Chi² for the subgroup comparison = 7.92, P 0.0005, Analysis 3.7.

  3. Routine use of EFM: four trials (n = 7467) were conducted in settings with routine EFM; RR 0.67, 95% CI 0.60 to 0.76. Four trials (n = 1710) were conducted in settings in which EFM was not routine; RR 0.60, 95% CI 0.53 to 0.68. Three trials (n = 1977) were in settings in which the use of routine EFM is not known; RR 0.84, 95% CI 0.65 to 1.08. Chi² for the subgroup comparison = 5.55, P = 0.06, Analysis 4.7.

  4. Provider characteristics: in four trials (n = 8145) support providers were hospital staff; RR 0.87, 95% CI 0.73 to 1.03. In three trials (n = 1325) the providers were not hospital staff and not part of the woman's social network; RR 0.66, 95% CI 0.57 to 0.77. In four trials (n = 1708), providers were part of the woman's social network; RR 0.57, 95% CI 0.51 to 0.64. Chi² for the subgroup comparison = 16.47, P = 0.0003, Analysis 5.7.

Thus the effectiveness of continuous support in reducing the likelihood of dissatisfaction with or negative views of the childbirth experience appeared to be stronger in settings in which epidural analgesia was not routinely available, and when the provider was neither a staff member nor part of the woman's social network.

Discussion

This review summarises results of 22 trials involving 15,288 women, conducted in 16 countries under a wide variety of circumstances. Continuous one-to-one support was given by providers with a variety of experiences, through having given birth themselves and/or through education and practice as nurses, midwives, doulas or childbirth educators, or by the woman's husband or partner, female relative or close friend. The methodological quality of the trials was generally good to excellent. For all outcomes in which summary statistics were computed, comparisons of fixed-effect and random-effects analyses did not yield material differences in the results. Thus neither the risk of bias nor heterogeneity should be of concern when interpreting results.

In the primary comparison, women who were allocated to continuous one-to-one support were more likely to have a spontaneous vaginal birth (risk ratio (RR) 1.08, 95% confidence interval (CI) 1.04 to 1.12) and less likely to have intrapartum analgesia (RR 0.90, 95% CI 0.84 to 0.96) or to report dissatisfaction (RR 0.69, 95% CI 0.59 to 0.79). In addition their labours were shorter (mean difference (MD) -0.58 hours, 95% CI -0.85 to -0.31), they were less likely to have a caesarean (RR 0.78, 95% CI 0.67 to 0.91) or instrumental vaginal birth (RR 0.90, 95% CI 0.85 to 0.96), regional analgesia (RR 0.93, 95% CI 0.88 to 0.99), or a baby with a low five-minute Apgar score (RR 0.69, 95% CI 0.50 to 0.95). The trial reports do not list any adverse effects. This form of care appears to confer important benefits without attendant risks. The results of earlier versions of this review prompted organisations in Canada, the UK and the USA to issue practice guidelines, advocating continuous support (AWHONN 2002; MIDIRS 1999; NICE Intrapartum Care 2007; SOGC 1995). The results of the primary comparison in the current review offer continued justification for such practice guidelines.

The subgroup analyses should be interpreted with caution. Individually each should be considered exploratory and hypothesis-generating, particularly when the sample size in one subgroup was much smaller than in another. However, taken in their totality, the consistency of the patterns suggests that the effectiveness of continuous intrapartum support may be enhanced or reduced by policies and practices in the birth setting and by the nature of the relationship between the provider and labouring woman.

We chose three aspects of the birth environment - routine use of electronic fetal monitoring (EFM), availability of epidural analgesia and policies about the presence of additional support people of the woman's own choosing - as proxies for environmental conditions that may mediate the effectiveness of labour support. This review cannot answer questions about the mechanisms whereby settings with epidural analgesia limit the effectiveness of labour support. The impact of epidural analgesia may be direct (Anim-Somuah 2011) or indirect, as part of the 'cascade of interventions' described in the Background. The effects of a policy of routine EFM are less clear, most likely because we were unable to obtain information about EFM policies for several of the trials. However, continuous labour support in settings without routine EFM was associated with greater likelihood of spontaneous vaginal birth and lower likelihood of a caesarean birth. These results raise questions about the ability of labour support to act as a buffer against adverse aspects of routine medical interventions. Labour support appears to be effective in reducing the adverse consequences of the fear and distress associated with labouring alone in an unfamiliar environment. A report of a qualitative component of one of the included trials (Langer 1998), aptly titled "Alone, I wouldn't have known what to do", provides further justification for this argument.

Effects of continuous labour support appear to vary by provider characteristics. Divided loyalties, additional duties besides labour support, self-selection and the constraints of institutional policies and routine practices may all have played a role in the apparently limited effectiveness of members of the hospital staff. Childbirth environments influence the healthcare professionals who work in them as well as labouring women and their support people. Furthermore, while women want and benefit from the presence of selected members of their social network, the support of partners and others with whom they have a longstanding relationship is qualitatively different and more complex than that of a woman who is experienced and often trained to provide labour support and who has no other role other than to provide it. An early trial of labour support with partners present found that women received more support from their partners when a doula was present to guide them, and the partners themselves reported more support (Hodnett 1989). While continuous labour support appears to be more effective when it is provided by caregivers who are not employees of an institution (and thus have no obligation to anyone other than the labouring woman) and who have an exclusive focus on this task, support from a member of the woman's social network is effective in improving women's satisfaction with their birth experiences.

There remains relatively little information about the effects of continuous intrapartum support on mothers' and babies' health and well-being in the postpartum period.

Authors' conclusions

Implications for practice

Continuous support during labour should be the norm, rather than the exception. Hospitals should permit and encourage women to have a companion of their choice during labour and birth, and hospitals should implement programs to offer continuous support during labour. Policy makers and hospital administrators in high-income countries who wish to effect clinically important reductions in inappropriately high caesarean rates should be cautioned that continuous support by nurses or midwives may not achieve this goal, in the absence of other changes to policies and routines. In many settings, the labour ward functions according to a risk-oriented, technology-dominated approach to care. Institutional staff are unlikely to be able to offer labouring women benefits comparable to non-staff members, in the absence of fundamental changes in the organisation and delivery of maternity care. Changes to the content of health professionals' education and to the core identity of professionals may also be important. Policy makers and administrators must look at system reform and rigorous attention to evidence-based use of interventions that were originally developed to diagnose or treat problems and are now used routinely during normal labours. Given the clear benefits and absence of adverse effects of continuous labour support, policy makers should consider including it as a covered service for all women.

Every effort should be made to ensure that women's birth environments are empowering, non-stressful, afford privacy, communicate respect and are not characterised by routine interventions that add risk without clear benefit. In most areas of the world, childbearing women have limited or no access to trained doulas. Where available, costs of doula services are frequently borne by childbearing families and may be a barrier to access. In areas where doulas are not available, a comprehensive guidebook for designated companions is available for those with good English literacy (Simkin 2007). The 'Better Births Initiative' is a structured motivational program which promotes humane, evidence-based care during labour. The program focuses on promoting labour companionship and avoiding unproven interventions such as routine starvation, supine position and routine episiotomy. The educational materials for the Better Births Initiative include a video presentation on childbirth companions which is available in the World Health Organization Reproductive Health Library (WHO 2010). It can be accessed free of charge on the Internet in Arabic, Chinese, French, English, Spanish, Russian and Vietnamese and is distributed on CD to health workers in resource-poor countries. The selection of Cochrane reviews in the Reproductive Health Library includes this review of continuous labour support.

Implications for research

There remains relatively little information about the effects of continuous intrapartum support on mothers' and babies' health and well-being in the postpartum period, and thus trials across all types of settings, which include a focus on longer-term outcomes for mother and baby, would be helpful. The trials in resource-constrained countries were relatively small, and additional, large trials may be required in such settings, where the cost of providing continuous support may compete with other resource priorities. Particular attention should be paid to outcomes that have been under-researched in resource-poor settings, but are causes of significant morbidity, including urinary and faecal incontinence, pain during intercourse, prolonged perineal pain and depression.

Trials of different models of training providers of labour support would help to inform decision makers about the most effective models in the context of their settings. All trials should include economic analyses of the relative costs and benefits.

Acknowledgements

We are very grateful to the investigators who provided additional information: O Bruggemann, D Campbell, R Cogan, A Gagnon, E Hemminki, M Kashanian, J Kennell, M Klaus, A Langer, B Madi, S McGrath, G Trueba, E Kopplin, and S Yuengong. We thank Agnes Cho, Qian Xu and Jiang Huangye for translation of Chinese publications, and Qian Xu for contacting the trial author for additional details. Ellen Hodnett and Justus Hofmeyr also provided additional information about their trials. Tanya Webb performed the second data entry on the earlier version of the review, contacted trial authors for additional information and provided secretarial support. The Consumer Panel of the Pregnancy and Childbirth Group (of which Carol Sakala is a member) provided many helpful suggestions for both the protocol and earlier versions of the review.

The National Institute for Health Research (NIHR) is the largest single funder of the Cochrane Pregnancy and Childbirth Group. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the NIHR, NHS or the Department of Health.

Data and analyses

Download statistical data

Comparison 1. Continuous support versus usual care - all trials
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Any analgesia/anaesthesia1412283Risk Ratio (M-H, Random, 95% CI)0.90 [0.84, 0.96]
2 Regional analgesia/anaesthesia911444Risk Ratio (M-H, Random, 95% CI)0.93 [0.88, 0.99]
3 Synthetic oxytocin during labour1512620Risk Ratio (M-H, Random, 95% CI)0.97 [0.91, 1.04]
4 Labour length125366Mean Difference (IV, Random, 95% CI)-0.58 [-0.85, -0.31]
5 Spontaneous vaginal birth1914119Risk Ratio (M-H, Random, 95% CI)1.08 [1.04, 1.12]
6 Instrumental vaginal birth1914118Risk Ratio (M-H, Fixed, 95% CI)0.90 [0.85, 0.96]
7 Caesarean birth2215175Risk Ratio (M-H, Random, 95% CI)0.78 [0.67, 0.91]
8 Perineal trauma48120Risk Ratio (M-H, Random, 95% CI)0.97 [0.92, 1.01]
9 Low 5-minute Apgar score1312515Risk Ratio (M-H, Fixed, 95% CI)0.69 [0.50, 0.95]
10 Admission to special care nursery78897Risk Ratio (M-H, Random, 95% CI)0.97 [0.76, 1.25]
11 Prolonged neonatal hospital stay31098Risk Ratio (M-H, Random, 95% CI)0.83 [0.42, 1.65]
12 Postpartum report of severe labour pain42456Risk Ratio (M-H, Random, 95% CI)1.00 [0.83, 1.21]
13 Negative rating of/negative feelings about birth experience1111133Risk Ratio (M-H, Random, 95% CI)0.69 [0.59, 0.79]
14 Difficulty mothering3 Risk Ratio (M-H, Fixed, 95% CI)Totals not selected
15 Breastfeeding at 1-2 months postpartum35363Risk Ratio (M-H, Random, 95% CI)1.01 [0.94, 1.09]
16 Postpartum depression2 Risk Ratio (M-H, Fixed, 95% CI)Totals not selected
17 Low postpartum self-esteem1652Risk Ratio (M-H, Fixed, 95% CI)1.00 [0.77, 1.30]
Analysis 1.1.

Comparison 1 Continuous support versus usual care - all trials, Outcome 1 Any analgesia/anaesthesia.

Analysis 1.2.

Comparison 1 Continuous support versus usual care - all trials, Outcome 2 Regional analgesia/anaesthesia.

Analysis 1.3.

Comparison 1 Continuous support versus usual care - all trials, Outcome 3 Synthetic oxytocin during labour.

Analysis 1.4.

Comparison 1 Continuous support versus usual care - all trials, Outcome 4 Labour length.

Analysis 1.5.

Comparison 1 Continuous support versus usual care - all trials, Outcome 5 Spontaneous vaginal birth.

Analysis 1.6.

Comparison 1 Continuous support versus usual care - all trials, Outcome 6 Instrumental vaginal birth.

Analysis 1.7.

Comparison 1 Continuous support versus usual care - all trials, Outcome 7 Caesarean birth.

Analysis 1.8.

Comparison 1 Continuous support versus usual care - all trials, Outcome 8 Perineal trauma.

Analysis 1.9.

Comparison 1 Continuous support versus usual care - all trials, Outcome 9 Low 5-minute Apgar score.

Analysis 1.10.

Comparison 1 Continuous support versus usual care - all trials, Outcome 10 Admission to special care nursery.

Analysis 1.11.

Comparison 1 Continuous support versus usual care - all trials, Outcome 11 Prolonged neonatal hospital stay.

Analysis 1.12.

Comparison 1 Continuous support versus usual care - all trials, Outcome 12 Postpartum report of severe labour pain.

Analysis 1.13.

Comparison 1 Continuous support versus usual care - all trials, Outcome 13 Negative rating of/negative feelings about birth experience.

Analysis 1.14.

Comparison 1 Continuous support versus usual care - all trials, Outcome 14 Difficulty mothering.

Analysis 1.15.

Comparison 1 Continuous support versus usual care - all trials, Outcome 15 Breastfeeding at 1-2 months postpartum.

Analysis 1.16.

Comparison 1 Continuous support versus usual care - all trials, Outcome 16 Postpartum depression.

Analysis 1.17.

Comparison 1 Continuous support versus usual care - all trials, Outcome 17 Low postpartum self-esteem.

Comparison 2. Continuous support versus usual care - policy regarding presence of companion
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Any analgesia/anaesthesia14 Risk Ratio (IV, Fixed, 95% CI)Subtotals only
1.1 Other support permitted79752Risk Ratio (IV, Fixed, 95% CI)0.97 [0.96, 0.99]
1.2 Other support not permitted72598Risk Ratio (IV, Fixed, 95% CI)0.91 [0.85, 0.96]
2 Synthetic oxytocin during labour15 Risk Ratio (IV, Fixed, 95% CI)Subtotals only
2.1 Other support permitted59495Risk Ratio (IV, Fixed, 95% CI)1.04 [0.99, 1.10]
2.2 Other support not permitted103125Risk Ratio (IV, Fixed, 95% CI)0.99 [0.97, 1.02]
3 Spontaneous vaginal birth19 Risk Ratio (IV, Fixed, 95% CI)Subtotals only
3.1 Other support permitted910889Risk Ratio (IV, Fixed, 95% CI)1.03 [1.00, 1.05]
3.2 Other support not permitted103329Risk Ratio (IV, Fixed, 95% CI)1.11 [1.07, 1.16]
4 Caesarean birth22 Risk Ratio (IV, Fixed, 95% CI)Subtotals only
4.1 Other support permitted1111326Risk Ratio (IV, Fixed, 95% CI)0.94 [0.85, 1.03]
4.2 Other support not permitted113849Risk Ratio (IV, Fixed, 95% CI)0.75 [0.65, 0.86]
5 Admission to special care nursery7 Risk Ratio (IV, Fixed, 95% CI)Subtotals only
5.1 Other support permitted27328Risk Ratio (IV, Fixed, 95% CI)0.99 [0.84, 1.17]
5.2 Other support not permitted51569Risk Ratio (IV, Fixed, 95% CI)0.91 [0.71, 1.17]
6 Postpartum depression2 Risk Ratio (IV, Fixed, 95% CI)Subtotals only
6.1 Other support permitted15567Risk Ratio (IV, Fixed, 95% CI)0.86 [0.73, 1.02]
6.2 Other support not permitted1149Risk Ratio (IV, Fixed, 95% CI)0.18 [0.09, 0.36]
7 Negative rating of/negative feelings about birth experience11 Risk Ratio (IV, Fixed, 95% CI)Subtotals only
7.1 Other support permitted58639Risk Ratio (IV, Fixed, 95% CI)0.70 [0.62, 0.78]
7.2 Other support not permitted62539Risk Ratio (IV, Fixed, 95% CI)0.62 [0.56, 0.69]
8 Breastfeeding at 1-2 months postpartum3 Risk Ratio (IV, Fixed, 95% CI)Subtotals only
8.1 Other support permitted14559Risk Ratio (IV, Fixed, 95% CI)0.97 [0.92, 1.02]
8.2 Other support not permitted2804Risk Ratio (IV, Fixed, 95% CI)1.05 [0.98, 1.13]
Analysis 2.1.

Comparison 2 Continuous support versus usual care - policy regarding presence of companion, Outcome 1 Any analgesia/anaesthesia.

Analysis 2.2.

Comparison 2 Continuous support versus usual care - policy regarding presence of companion, Outcome 2 Synthetic oxytocin during labour.

Analysis 2.3.

Comparison 2 Continuous support versus usual care - policy regarding presence of companion, Outcome 3 Spontaneous vaginal birth.

Analysis 2.4.

Comparison 2 Continuous support versus usual care - policy regarding presence of companion, Outcome 4 Caesarean birth.

Analysis 2.5.

Comparison 2 Continuous support versus usual care - policy regarding presence of companion, Outcome 5 Admission to special care nursery.

Analysis 2.6.

Comparison 2 Continuous support versus usual care - policy regarding presence of companion, Outcome 6 Postpartum depression.

Analysis 2.7.

Comparison 2 Continuous support versus usual care - policy regarding presence of companion, Outcome 7 Negative rating of/negative feelings about birth experience.

Analysis 2.8.

Comparison 2 Continuous support versus usual care - policy regarding presence of companion, Outcome 8 Breastfeeding at 1-2 months postpartum.

Comparison 3. Continuous support versus usual care - availability of epidural analgesia
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Any analgesia/anaesthesia14 Risk Ratio (IV, Fixed, 95% CI)Subtotals only
1.1 Epidural analgesia routinely available910888Risk Ratio (IV, Fixed, 95% CI)0.97 [0.96, 0.98]
1.2 Epidural analgesia not routinely available51462Risk Ratio (IV, Fixed, 95% CI)0.83 [0.69, 0.99]
2 Synthetic oxytocin during labour15 Risk Ratio (IV, Fixed, 95% CI)Subtotals only
2.1 Epidural analgesia routinely available810568Risk Ratio (IV, Fixed, 95% CI)1.00 [0.98, 1.02]
2.2 Epidural analgesia not routinely available72066Risk Ratio (IV, Fixed, 95% CI)1.02 [0.93, 1.11]
3 Spontaneous vaginal birth19 Risk Ratio (IV, Fixed, 95% CI)Subtotals only
3.1 Epidural analgesia routinely available1312672Risk Ratio (IV, Fixed, 95% CI)1.04 [1.01, 1.06]
3.2 Epidural analgesia not routinely available61546Risk Ratio (IV, Fixed, 95% CI)1.11 [1.06, 1.17]
4 Caesarean birth22 Risk Ratio (IV, Fixed, 95% CI)Subtotals only
4.1 Epidural analgesia routinely available1413064Risk Ratio (IV, Fixed, 95% CI)0.93 [0.86, 1.02]
4.2 Epidural analgesia not routinely available72077Risk Ratio (IV, Fixed, 95% CI)0.54 [0.43, 0.68]
4.3 Unknown availability of epidural analgesia134Risk Ratio (IV, Fixed, 95% CI)1.4 [0.14, 13.98]
5 Admission to special care nursery7 Risk Ratio (IV, Fixed, 95% CI)Subtotals only
5.1 Epidural analgesia routinely available58380Risk Ratio (IV, Fixed, 95% CI)0.98 [0.85, 1.13]
5.2 Epidural analgesia not routinely available2517Risk Ratio (IV, Fixed, 95% CI)0.26 [0.08, 0.88]
6 Postpartum depression2 Risk Ratio (IV, Fixed, 95% CI)Subtotals only
6.1 Epidural analgesia routinely available16915Risk Ratio (IV, Fixed, 95% CI)0.89 [0.75, 1.05]
6.2 Epidural analgesia not routinely available1149Risk Ratio (IV, Fixed, 95% CI)0.18 [0.09, 0.36]
7 Negative rating of/negative feelings about birth experience11 Risk Ratio (IV, Fixed, 95% CI)Subtotals only
7.1 Epidural analgesia routinely available910404Risk Ratio (IV, Fixed, 95% CI)0.70 [0.64, 0.77]
7.2 Epidural analgesia not routinely available2774Risk Ratio (IV, Fixed, 95% CI)0.55 [0.48, 0.63]
8 Breastfeeding at 1-2 months postpartum3 Risk Ratio (IV, Fixed, 95% CI)Subtotals only
8.1 Epidural analgesia routinely available25214Risk Ratio (IV, Fixed, 95% CI)0.99 [0.95, 1.03]
8.2 Epidural analgesia not routinely available1149Risk Ratio (IV, Fixed, 95% CI)1.15 [0.95, 1.40]
Analysis 3.1.

Comparison 3 Continuous support versus usual care - availability of epidural analgesia, Outcome 1 Any analgesia/anaesthesia.

Analysis 3.2.

Comparison 3 Continuous support versus usual care - availability of epidural analgesia, Outcome 2 Synthetic oxytocin during labour.

Analysis 3.3.

Comparison 3 Continuous support versus usual care - availability of epidural analgesia, Outcome 3 Spontaneous vaginal birth.

Analysis 3.4.

Comparison 3 Continuous support versus usual care - availability of epidural analgesia, Outcome 4 Caesarean birth.

Analysis 3.5.

Comparison 3 Continuous support versus usual care - availability of epidural analgesia, Outcome 5 Admission to special care nursery.

Analysis 3.6.

Comparison 3 Continuous support versus usual care - availability of epidural analgesia, Outcome 6 Postpartum depression.

Analysis 3.7.

Comparison 3 Continuous support versus usual care - availability of epidural analgesia, Outcome 7 Negative rating of/negative feelings about birth experience.

Analysis 3.8.

Comparison 3 Continuous support versus usual care - availability of epidural analgesia, Outcome 8 Breastfeeding at 1-2 months postpartum.

Comparison 4. Continuous support versus usual care - policy about routine EFM
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Any analgesia/anaesthesia14 Risk Ratio (IV, Fixed, 95% CI)Subtotals only
1.1 Setting had routine EFM68580Risk Ratio (IV, Fixed, 95% CI)0.97 [0.96, 0.99]
1.2 Setting did not have routine EFM62186Risk Ratio (IV, Fixed, 95% CI)0.96 [0.90, 1.02]
1.3 Policy about routine EFM not known21579Risk Ratio (IV, Fixed, 95% CI)0.89 [0.80, 0.99]
2 Synthetic oxytocin during labour15 Risk Ratio (IV, Fixed, 95% CI)Subtotals only
2.1 Setting had routine EFM48340Risk Ratio (IV, Fixed, 95% CI)1.04 [0.98, 1.11]
2.2 Setting did not have routine EFM71726Risk Ratio (IV, Fixed, 95% CI)0.99 [0.96, 1.01]
2.3 Policy about routine EFM not known42568Risk Ratio (IV, Fixed, 95% CI)1.02 [0.97, 1.08]
3 Spontaneous vaginal birth19 Risk Ratio (IV, Fixed, 95% CI)Subtotals only
3.1 Setting had routine EFM89717Risk Ratio (IV, Fixed, 95% CI)1.03 [1.01, 1.06]
3.2 Setting did not have routine EFM71913Risk Ratio (IV, Fixed, 95% CI)1.11 [1.06, 1.17]
3.3 Policy about routine EFM not known42561Risk Ratio (IV, Fixed, 95% CI)1.07 [1.01, 1.13]
4 Caesarean birth22 Risk Ratio (IV, Fixed, 95% CI)Subtotals only
4.1 Setting had routine EFM910123Risk Ratio (IV, Fixed, 95% CI)0.92 [0.83, 1.01]
4.2 Setting did not have routine EFM82457Risk Ratio (IV, Fixed, 95% CI)0.66 [0.55, 0.79]
4.3 Policy about routine EFM not known52595Risk Ratio (IV, Fixed, 95% CI)1.06 [0.84, 1.33]
5 Admission to special care nursery7 Risk Ratio (IV, Fixed, 95% CI)Subtotals only
5.1 Setting had routine EFM37740Risk Ratio (IV, Fixed, 95% CI)0.97 [0.84, 1.11]
5.2 Setting did not have routine EFM3729Risk Ratio (IV, Fixed, 95% CI)0.48 [0.21, 1.12]
5.3 Policy about routine EFM not known1428Risk Ratio (IV, Fixed, 95% CI)1.98 [0.76, 5.18]
6 Postpartum depression2 Risk Ratio (IV, Fixed, 95% CI)Subtotals only
6.1 Setting had routine EFM16915Risk Ratio (IV, Fixed, 95% CI)0.89 [0.75, 1.05]
6.2 Setting did not have routine EFM1149Risk Ratio (IV, Fixed, 95% CI)0.18 [0.09, 0.36]
7 Negative rating of/negative views about birth experience11 Risk Ratio (IV, Fixed, 95% CI)Subtotals only
7.1 Setting had routine EFM47467Risk Ratio (IV, Fixed, 95% CI)0.67 [0.60, 0.76]
7.2 Setting did not have routine EFM41710Risk Ratio (IV, Fixed, 95% CI)0.60 [0.53, 0.68]
7.3 Policy about routine EFM not known31977Risk Ratio (IV, Fixed, 95% CI)0.84 [0.65, 1.08]
8 Breastfeeding at 1-2 months postpartum3 Risk Ratio (IV, Fixed, 95% CI)Subtotals only
8.1 Setting had routine EFM14559Risk Ratio (IV, Fixed, 95% CI)0.97 [0.92, 1.02]
8.2 Setting did not have routine EFM2804Risk Ratio (IV, Fixed, 95% CI)1.05 [0.98, 1.13]
Analysis 4.1.

Comparison 4 Continuous support versus usual care - policy about routine EFM, Outcome 1 Any analgesia/anaesthesia.

Analysis 4.2.

Comparison 4 Continuous support versus usual care - policy about routine EFM, Outcome 2 Synthetic oxytocin during labour.

Analysis 4.3.

Comparison 4 Continuous support versus usual care - policy about routine EFM, Outcome 3 Spontaneous vaginal birth.

Analysis 4.4.

Comparison 4 Continuous support versus usual care - policy about routine EFM, Outcome 4 Caesarean birth.

Analysis 4.5.

Comparison 4 Continuous support versus usual care - policy about routine EFM, Outcome 5 Admission to special care nursery.

Analysis 4.6.

Comparison 4 Continuous support versus usual care - policy about routine EFM, Outcome 6 Postpartum depression.

Analysis 4.7.

Comparison 4 Continuous support versus usual care - policy about routine EFM, Outcome 7 Negative rating of/negative views about birth experience.

Analysis 4.8.

Comparison 4 Continuous support versus usual care - policy about routine EFM, Outcome 8 Breastfeeding at 1-2 months postpartum.

Comparison 5. Continuous support versus usual care - variations in provider characteristics
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Any analgesia/anaesthesia14 Risk Ratio (IV, Fixed, 95% CI)Subtotals only
1.1 Support people were hospital staff69152Risk Ratio (IV, Fixed, 95% CI)0.97 [0.96, 0.99]
1.2 Support people were not hospital staff and not chosen by woman41790Risk Ratio (IV, Fixed, 95% CI)0.91 [0.86, 0.97]
1.3 Support people were not hospital staff and were chosen by woman41408Risk Ratio (IV, Fixed, 95% CI)0.94 [0.88, 1.00]
2 Synthetic oxytocin during labour15 Risk Ratio (IV, Fixed, 95% CI)Subtotals only
2.1 Support people were hospital staff69561Risk Ratio (IV, Fixed, 95% CI)1.06 [1.01, 1.11]
2.2 Support people were not hospital staff and not chosen by woman31018Risk Ratio (IV, Fixed, 95% CI)0.69 [0.50, 0.94]
2.3 Support people were not hospital staff and were chosen by woman62041Risk Ratio (IV, Fixed, 95% CI)0.99 [0.96, 1.01]
3 Spontaneous vaginal birth19 Risk Ratio (IV, Fixed, 95% CI)Subtotals only
3.1 Support people were hospital staff910813Risk Ratio (IV, Fixed, 95% CI)1.03 [1.01, 1.06]
3.2 Support people were not hospital staff and were chosen by woman51470Risk Ratio (IV, Fixed, 95% CI)1.07 [0.99, 1.15]
3.3 Support people were not hospital staff and not chosen by woman51935Risk Ratio (IV, Fixed, 95% CI)1.12 [1.07, 1.17]
4 Caesarean birth22 Risk Ratio (IV, Fixed, 95% CI)Subtotals only
4.1 Support people were hospital staff910786Risk Ratio (IV, Fixed, 95% CI)0.95 [0.85, 1.05]
4.2 Support people were not hospital staff and not chosen by woman72330Risk Ratio (IV, Fixed, 95% CI)0.72 [0.60, 0.86]
4.3 Support people were not hospital staff and were chosen by woman62059Risk Ratio (IV, Fixed, 95% CI)0.83 [0.69, 1.01]
5 Admission to special care nursery7 Risk Ratio (IV, Fixed, 95% CI)Subtotals only
5.1 Support people were hospital staff37428Risk Ratio (IV, Fixed, 95% CI)0.99 [0.84, 1.17]
5.2 Support people were not hospital staff and not chosen by woman2829Risk Ratio (IV, Fixed, 95% CI)0.86 [0.66, 1.12]
5.3 Support people were not hospital staff and were chosen by woman2640Risk Ratio (IV, Fixed, 95% CI)1.40 [0.67, 2.93]
6 Postpartum depression2 Risk Ratio (IV, Fixed, 95% CI)Subtotals only
6.1 Support people were hospital staff15567Risk Ratio (IV, Fixed, 95% CI)0.86 [0.73, 1.02]
6.2 Support people were not hospital staff and not chosen by woman1149Risk Ratio (IV, Fixed, 95% CI)0.17 [0.09, 0.33]
6.3 Support people were not hospital staff and were chosen by woman00Risk Ratio (IV, Fixed, 95% CI)0.0 [0.0, 0.0]
7 Negative rating of/negative feelings about birth experience11 Risk Ratio (IV, Fixed, 95% CI)Subtotals only
7.1 Support people were hospital staff48145Risk Ratio (IV, Fixed, 95% CI)0.87 [0.73, 1.03]
7.2 Support people were not hospital staff and not chosen by woman31325Risk Ratio (IV, Fixed, 95% CI)0.66 [0.57, 0.77]
7.3 Support people were not hospital staff and were chosen by woman41708Risk Ratio (IV, Fixed, 95% CI)0.57 [0.51, 0.64]
8 Breastfeeding at 1-2 months postpartum3 Risk Ratio (IV, Fixed, 95% CI)Subtotals only
8.1 Support people were hospital staff14559Risk Ratio (IV, Fixed, 95% CI)0.97 [0.92, 1.02]
8.2 Support people were not hospital staff and not chosen by woman2804Risk Ratio (IV, Fixed, 95% CI)1.05 [0.98, 1.13]
8.3 Support people were not hospital staff and were chosen by woman00Risk Ratio (IV, Fixed, 95% CI)0.0 [0.0, 0.0]
Analysis 5.1.

Comparison 5 Continuous support versus usual care - variations in provider characteristics, Outcome 1 Any analgesia/anaesthesia.

Analysis 5.2.

Comparison 5 Continuous support versus usual care - variations in provider characteristics, Outcome 2 Synthetic oxytocin during labour.

Analysis 5.3.

Comparison 5 Continuous support versus usual care - variations in provider characteristics, Outcome 3 Spontaneous vaginal birth.

Analysis 5.4.

Comparison 5 Continuous support versus usual care - variations in provider characteristics, Outcome 4 Caesarean birth.

Analysis 5.5.

Comparison 5 Continuous support versus usual care - variations in provider characteristics, Outcome 5 Admission to special care nursery.

Analysis 5.6.

Comparison 5 Continuous support versus usual care - variations in provider characteristics, Outcome 6 Postpartum depression.

Analysis 5.7.

Comparison 5 Continuous support versus usual care - variations in provider characteristics, Outcome 7 Negative rating of/negative feelings about birth experience.

Analysis 5.8.

Comparison 5 Continuous support versus usual care - variations in provider characteristics, Outcome 8 Breastfeeding at 1-2 months postpartum.

What's new

Last assessed as up-to-date: 29 June 2013.

DateEventDescription
29 June 2013New search has been performedSearch updated. One new abstract identified and added to Characteristics of studies awaiting classification because it does not contain sufficient details to permit classification (Safarzadeh 2013).
29 June 2013New citation required but conclusions have not changedReview updated. No new trials or data included.

History

Protocol first published: Issue 3, 2002
Review first published: Issue 3, 2003

DateEventDescription
12 July 2012New citation required but conclusions have not changedOne new trial added (Yuenyong 2012). Data inadvertently omitted for one outcome (postpartum depression) from a prior trial (Hofmeyr 1991) have now been included. Minor clarifications to the text and changes to Results which did not substantively alter Conclusions.
14 June 2012New search has been performedSearch updated and one new trial met inclusion criteria. One other trial report and seven new abstracts were found, one of which describes an ongoing study, and none of which contain sufficient details to permit classification.
31 December 2010New search has been performedSearch updated. We evaluated and added new trials. We obtained additional information from trial authors. Other revisions included numerous changes to bring the entire Review up-to-date in terms of current methodological guidelines. We altered the acceptable follow-up rate for long term outcomes, and we expanded the number of outcomes to be included in the planned subgroup analyses.
25 October 2010New citation required but conclusions have not changedNew author joined the review team to update the review.
12 May 2008AmendedConverted to new review format.
18 April 2007New search has been performedSearch updated in February 2007. Two new trials identified. We excluded one (Dalal 2006) and included the other (Campbell 2006). The Results section was updated accordingly. With the exception of the outcome of labour length, there were no substantive changes in results or conclusions of the Review. Minor edits were made throughout. Additional text was added to the Discussion.
30 October 2006New search has been performedSearch updated. One 'awaiting assessment' trial was assessed and included (Thomassen 2003).

Contributions of authors

Ellen Hodnett wrote the initial draft of the protocol. Carol Sakala wrote the initial draft of the Discussion in the previous version of the review. Simon Gates wrote the initial draft of the statistical methods and provided statistical advice for the protocol and each update of the review. All review authors participated in all aspects of the preparation of the protocol and in writing the text of the review. All authors participated in the updates of the review.

Declarations of interest

Ellen Hodnett was the principal investigator for two labour support trials. Justus Hofmeyr was the principal investigator for one labour support trial.

Sources of support

Internal sources

  • University of Toronto, Canada.

  • University of the Witwatersrand, South Africa.

  • Fort Hare University, South Africa.

  • East London Hospital Complex, South Africa.

  • National Perinatal Epidemiology Unit, Oxford, UK.

  • Childbirth Connection (formerly Maternity Center Association), USA.

  • Warwick Clinical Trials Unit, University of Warwick, UK.

External sources

  • National Institute for Health Research, UK.

    NIHR Programme of centrally-managed pregnancy and childbirth systematic reviews of priority to the NHS and users of the NHS:10/4001/02

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Breart - Belgium 1992

MethodsRCT.
Participants3 trials are reported separately, within 1 publication. Participants were nulliparous, healthy, in spontaneous labour, term, with singleton vertex presentations.
Trial in Belgium: n = 264 (133 permanent support; 131 control).
InterventionsPermanent presence of a midwife compared to varying degrees of presence. Fathers were allowed to be present.
OutcomesOxytocin, epidural analgesia, labour length, mode of birth, Apgar scores, mothers' views of their experiences.
NotesEpidural analgesia was available and it is not known whether EFM was used routinely.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskWomen were 'randomly assigned'. The envelopes were prepared by the co-ordinating centre. No mention of the process of sequence generation.
Allocation concealment (selection bias)Unclear riskSealed envelopes. No mention if they were opaque or consecutively numbered. The process of how the envelopes were opened was not described.
Blinding (performance bias and detection bias)
All outcomes
Unclear riskNo details given.
Incomplete outcome data (attrition bias)
All outcomes
Low riskCompletion rate for medical record data and in-hospital questionnaire were 99.2% and 91.0% respectively.
Selective reporting (reporting bias)Low riskAll outcomes were reported.
Other biasLow riskNo other sources of bias noted.

Breart - France 1992

MethodsSee Breart - Belgium.
ParticipantsSee Breart - Belgium.
Trial in France: n = 1320 (656 continuous support; 664 control).
InterventionsSee Breart - Belgium. Fathers were allowed to be present.
OutcomesSee Breart - Belgium.
NotesEpidural analgesia was available and it is unknown whether EFM was routine.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskWomen were 'randomly assigned'. The envelopes were prepared by the co-ordinating centre. No mention of the process of sequence generation.
Allocation concealment (selection bias)Unclear riskSealed envelopes. No mention if they were opaque or consecutively numbered. The process of how the envelopes were opened was not described.
Blinding (performance bias and detection bias)
All outcomes
Unclear riskNo details given.
Incomplete outcome data (attrition bias)
All outcomes
Low riskCompletion rate for medical record data and in-hospital questionnaire was > 95%. There were some discrepancies in the total number enrolled. 2 reports show 656 in the permanent support group and 664 in the control group for a total of 1320. The table of results in 1 report shows 654 in the permanent support and 666 in control. The in-hospital questionnaire results are shown for 654 and 664 women (total 1318) but the authors state this is 95% of the sample, meaning the total is 1386. The n reported with each outcome was the one used in the data tables in this review.
Selective reporting (reporting bias)Low riskAll outcomes were reported.
Other biasLow riskNo other sources of bias noted.

Breart - Greece 1992

MethodsSee Breart - Belgium.
ParticipantsSee Breart - Belgium. Trial in Greece: n = 569 (295 permanent support; 274 control).
InterventionsSee Breart - Belgium. Fathers/family members were not permitted to be present.
OutcomesSee Breart - Belgium, except that mothers' views were not reported.
NotesEpidural analgesia was not available. Not stated if EFM was used routinely.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskWomen were 'randomly assigned'. The envelopes were prepared by the co-ordinating centre. No mention of the process of sequence generation.
Allocation concealment (selection bias)Unclear riskSealed envelopes. No mention if they were opaque or consecutively numbered. The process of how the envelopes were opened was not described.
Blinding (performance bias and detection bias)
All outcomes
Unclear riskNo details given.
Incomplete outcome data (attrition bias)
All outcomes
Low riskCompletion rate for medical record data was 97%. No in-hospital questionnaire data were available.
Selective reporting (reporting bias)Low riskAll medical record outcomes were reported.
Other biasLow riskNo other sources of bias noted.

Bruggemann 2007

MethodsRCT.
Participants212 nulliparous women in active labour at term (105 support group, 107 control group) at a University-affiliated hospital in Sao Paulo, Brazil. To be eligible a companion of the woman's choosing had to be available. 49.5% of the companions were present at enrolment and the others were phoned and asked to come to the hospital (4 failed to make it before delivery).
Interventions

Support was 'presence of a chosen companion during labour and delivery'. 'The companions received verbal and written information on the activities involved in providing support, expected behaviour when confronted with signs of tiredness, anxiety, concern, crying, screaming and/or the woman's feelings of inability to cope, compliance with regulations and the possibility of requesting information from staff'. in 47.6% of the sample the woman's companion was her partner, for 29.5% it was her mother.

The control group received usual care where a companion during labour and delivery was not permitted.

For both groups labour and delivery care was provided 'according to the routine protocol including active management of labour (early amniotomy, use of oxytocin, intermittent EFM and systematic analgesia)'.

OutcomesSatisfaction with labour and delivery, perinatal and breastfeeding outcome in the 12 hours post delivery.
Notes

All women in labour at this hospital received epidural analgesia as a routine practice. Therefore, we did not include epidural analgesia data in the review.

EFM was not used routinely.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk'Computer generated sequence of random numbers.'
Allocation concealment (selection bias)High risk

'Individual assignment numbers were all placed in an opaque container to assure the concealment. The eligible women who had agreed to participate selected one of the numbers once, and were therefore allocated to either intervention group or control according to the list.'

This process was open to selection bias as women could have re-picked another number from the container. No audit process is possible with this system of randomisation.

Blinding (performance bias and detection bias)
All outcomes
High riskData collection by author, who knew group allocation.
Incomplete outcome data (attrition bias)
All outcomes
Low riskMedical record data were collected and in-hospital questionnaires were completed for 100% of sample.
Selective reporting (reporting bias)Low riskAll outcomes were reported.
Other biasLow riskNo other sources of bias noted.

Campbell 2006

MethodsRCT.
Participants600 nulliparous, low-income, under-insured pregnant women (300 doula group, 300 control group) booked for delivery at a hospital in New Jersey, USA were enrolled between 12 and 38 weeks' gestation. They were considered low risk, with no contraindications to labour and had a female friend or relative willing to act as their lay doula. The doula was in addition to support people of their own choosing.
Interventions

Intervention: continuous support by a female friend or relative who had had 2, 2-hour sessions about labour support. The training sessions were conducted for nearly all of the lay caregivers when the participants were 34-36 weeks' gestation.

Control group: support people of their own choosing.

OutcomesLabour length, epidural analgesia, oxytocin augmentation, cervical dilation at epidural insertion, length of second stage labour, caesarean birth, 1-min Apgar score > 6, 5-min Apgar score > 6.
NotesEpidural analgesia was available and EFM was used routinely.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk'Computer generated randomization scheme.'
Allocation concealment (selection bias)Low riskConsecutively-numbered, sealed opaque envelopes contained treatment assignments. After obtaining consent, a research assistant opened the next envelope. It was unclear whether the research assistant enrolling the woman was the same one that opened the envelope.
Blinding (performance bias and detection bias)
All outcomes
High riskMedical record abstraction was done by the author who was not blinded. The 6-week questionnaire data collection was not blinded.
Incomplete outcome data (attrition bias)
All outcomes
High riskMedical record information was completed for 97.7% of the sample (82.3% in the intervention group and 94.3% in the control group). The differential rates are due to withdrawals from the intervention group for doula related reasons (incomplete training and not being present during labour). The 6-week questionnaire was completed for 82.3% of the sample. Only those women included in the study at delivery had the opportunity to complete the questionnaire and thus the differential completion rate between groups remained (76.3% in the intervention group and 88.3% in the control group). The differential withdrawals could introduce selection bias.
Selective reporting (reporting bias)Low riskAll outcomes were reported.
Other biasUnclear riskThe training of the doulas giving the intervention was done by the research assistant, who was herself a doula. This same research assistant enrolled all study participants.

Cogan 1988

MethodsRCT.
Participants34 women (primigravidas and multigravidas) at 26-37 weeks' gestation in 2 Texas hospitals (20 to supported group and 14 to usual care). They were in early, uncomplicated preterm labour.
Interventions

Intervention: support provided by a Lamaze childbirth preparation instructor. Support included continuous presence, acting as a liaison with hospital staff, providing information, and teaching relaxation and breathing measures.

Usual care: intermittent nursing care. Family members allowed to be present.

OutcomesFetal distress, caesarean birth, artificial oxytocin, labour length, Apgar scores, neonatal intensive care.
NotesNot stated if epidural analgesia was available or if EFM was used routinely.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk'Randomly assigned.' No further details provided.
Allocation concealment (selection bias)Unclear riskAdmitting nurse telephoned research assistant to obtain treatment allocation. No details about whether the research assistant had foreknowledge of the treatment allocation scheme.
Blinding (performance bias and detection bias)
All outcomes
Low riskMedical record information collected by 'research assistants who did not know the group membership of the women'.
Incomplete outcome data (attrition bias)
All outcomes
High riskWithdrawals occurred before analysis (6 (30%) in support group and 3 (21%) in control). This resulted in a follow-up rate of 73.5%. The withdrawals were done differentially in the support group, i.e. some women were withdrawn because of an event that occurred before the support person arrived. Women in the control group with the same event were not withdrawn. We were able to re-create the original study groups for 1 outcome only, caesarean birth, and therefore it is included in the analysis table.
Selective reporting (reporting bias)Unclear riskNo outcomes were stated a priori.
Other biasLow riskNo other sources of bias noted.

Dickinson 2002

MethodsRCT, stratified by induced or spontaneous labour at trial entry.
Participants992 nulliparous women at term (499 to continuous support and 493 to control), cephalic fetal presentation, cervical dilatation < 5 cm, in a hospital in Perth, Western Australia.
InterventionsGroup 1: continuous physical and emotional support by midwifery staff, and women were encouraged to use pharmacologic and nonpharmacologic alternatives to epidural analgesia.
Group 2: continuous midwifery support was not provided and women were encouraged to have epidural analgesia as their primary method of pain relief in labour.
OutcomesLabour length (expressed as median and interquartile range), epidural analgesia, mode of delivery, 5 min Apgar score < 7, arterial cord pH.
Notes

The stated purpose was to compare the effects of intrapartum analgesic techniques on labour outcomes. Continuous midwifery support was conceptualised as an analgesic technique. Both groups had access to opioids and nitrous oxide. No data were presented about the number of women who used no pharmacologic analgesia. Because the type of analgesia used was a measure of compliance rather than an outcome, no data on analgesic outcomes are included in this review.

It was not stated if other support person was allowed. epidural analgesia was available and EFM was used routinely.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNo details about how the blocks of treatment allocations were produced.
Allocation concealment (selection bias)Unclear riskRandomisation on presentation in the labour and delivery unit, "by selection from a blocked group of eight sealed opaque envelopes, replenished from blocks of 12". No further details about process.
Blinding (performance bias and detection bias)
All outcomes
Unclear riskNot noted.
Incomplete outcome data (attrition bias)
All outcomes
Low riskThere was 100% follow-up for medical record data and in-hospital survey. A 6-month questionnaire was completed by 64.7% of the sample and these data were not used.
Selective reporting (reporting bias)Low riskAll main outcomes were reported. Effects on breastfeeding were not analysed by treatment group and thus the results could not be included in the review.
Other biasLow riskNo other sources of bias noted.

Gagnon 1997

MethodsRCT.
Participants413 women admitted to an intrapartum unit at a tertiary care teaching hospital in Montreal, Canada, were randomly allocated to experimental (n = 209) or control (n = 204) groups. All but 3 in the experimental group and 6 in the control group were accompanied by a spouse, relative or friend during labour. All participants were nulliparous, with singleton fetuses, > 37 weeks' gestation, and in labour.
Interventions

Experimental: 1-to-1 nursing care from randomisation until 1 hour postbirth. Care was provided by on-call nurses who were hired specifically for the study and had received a 30-hour training program and quarterly refresher workshops. The training program included critical reviews of the literature concerning the effects of intrapartum medical and nursing practices, as well as discussions of stress and pain management techniques. The nurse provided the usual nursing care plus physical comfort, emotional support, and instruction on relaxation and coping techniques. The nurse took meal breaks and brief rest breaks.

Women in the comparison group received usual nursing care by the regular unit staff, consisting of intermittent support and monitoring.

OutcomesCaesarean birth, caesarean birth for cephalopelvic disproportion or failure to progress, post-randomisation artificial oxytocin augmentation, post-randomisation analgesia/anaesthesia, instrumental vaginal delivery (forceps or vacuum extraction), NICU admission, perineal trauma, mean duration of labour post-randomisation, postpartum urinary catheterisation.
Notes

The participants had been admitted to the unit for an average of 5 hours (SD = 4 hours) prior to randomisation. 36 women in the experimental group and 41 in the control group had epidural analgesia prior to randomisation. 55 women in the experimental group and 45 in the control group had intravenous oxytocin augmentation of labour prior to randomisation. Mean duration of labour post-randomisation was 9.2 hours (SD = 4.3).

Epidural analgesia was available but it was not stated if EFM was used routinely.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk'Randomized using a list of computer generated random numbers.'
Allocation concealment (selection bias)Low risk'Randomized in blocks of eight.' 'Group assignments were placed in sequentially numbered, sealed, opaque envelopes.'
Blinding (performance bias and detection bias)
All outcomes
High riskData collectors were not blinded as they read nurses notes to collect data.
Incomplete outcome data (attrition bias)
All outcomes
Low risk100% follow-up.
Selective reporting (reporting bias)Low riskAll outcomes were reported.
Other biasLow riskNo other sources of bias noted.

Hemminki 1990a

Methods2 RCTs reported in the same publication. The Zelen method was used: only those participants randomised to the experimental group were told the true purpose of the trial and asked for consent. The participants in the control group were told about the study in the introduction letter for the postpartum questionnaire and they were told it was 'a study on factors influencing birth'.
ParticipantsHealthy nulliparous and parous women in labour at a hospital in Finland. 86 women were enrolled in Trial A. The actual number enrolled to each group was not noted but medical record data were collected for 79 women (41 in the support group and 38 in the control group). These 79 women represented 91.9% of the total sample.
Interventions

Trial A: in 1987, the intervention was 1:1 support by midwifery students from enrolment until transfer to the postpartum ward. The midwifery students volunteered, were not specially trained in support and responsible for the other routine intrapartum care.

The control group 'was cared for according to the normal routine of the midwife and by a medical student, if s(he) was on duty'.

Over 70% of fathers were present.

OutcomesLabour length, medical interventions, complications (mother and baby), pharmacologic pain relief, method of birth, mothers' evaluations of their experiences.
NotesNot stated if epidural analgesia was available or if EFM was used routinely.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNo mention of how the allocation sequence was produced.
Allocation concealment (selection bias)Unclear risk'Randomization coding was done in blocks of 6 and put into non-transparent envelopes. The envelope was opened at the reception ward when it was decided to transfer mother to labour ward.' It was not stated if the envelopes were consecutively numbered.
Blinding (performance bias and detection bias)
All outcomes
High riskMedical record outcome were collected unblinded.
Incomplete outcome data (attrition bias)
All outcomes
Low riskMedical record data were collected on 91.9% of the sample. A questionnaire was administered at 2-3 days postpartum. This was completed by only 70% of the sample and thus the data were not used.
Selective reporting (reporting bias)Low riskAll outcomes were reported.
Other biasHigh riskMothers were told the purpose of the study differentially (see methods for Trial A above).

Hemminki 1990b

MethodsSee Hemminki 1990a.
ParticipantsSee Hemminki 1990a. 161 women were enrolled in Trial B (81 in the support group and 80 in control).
Interventions

Trial B: in 1988, the intervention was support by a new group of midwifery students. All students were involved in the trial, not just volunteers. The students were permitted to leave their participants to witness other interventions and deliveries.

The control group 'was cared for according to the normal routine of the midwife' and by a medical student as enrolment was limited to days when medical students were on duty.

Slightly less than 70% of fathers were present.

OutcomesSee Hemminki 1990a.
NotesNot stated if epidural analgesia was available or if EFM was used routinely.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNo details provided.
Allocation concealment (selection bias)Unclear riskThe block size was reduced from the first study. 'To lessen the frustration resulting from opening a code for a control mother, randomisation envelopes contained a maximum of two similar codes in sequence (not told in advance)'. 'Put into non-transparent envelopes'. The envelope was opened in the labour ward. It was not stated if the envelopes were consecutively numbered.
Blinding (performance bias and detection bias)
All outcomes
High riskMedical record outcome were collected unblinded.
Incomplete outcome data (attrition bias)
All outcomes
Low riskMedical record data were collected on 100% of the sample. A questionnaire was administered at 2-3 days postpartum and completed by 93.7% of the sample.
Selective reporting (reporting bias)Low riskAll outcomes were reported.
Other biasHigh riskMothers were told the purpose of the study differentially (see methods for Trial A above).

Hodnett 1989

MethodsRCT, stratified by type of prenatal classes (Lamaze vs general).
Participants145 nulliparous women (72 to support group and 73 to control) in the last trimester of a healthy pregnancy, booked for delivery at a Toronto, Canada, hospital.
Interventions

Support provided by a monitrice (community 'lay' midwife or midwifery apprentice) compared with usual hospital care, defined as the intermittent presence of a nurse. Support described as including physical comfort measures, continuous presence, information, emotional support, and advocacy. The monitrice met with the woman twice in the latter weeks of pregnancy, to discuss her birth plans.

Comparable prenatal attention was provided to the controls.

All but 1 woman also had husbands or partners present during labour. Support began in early labour at home or in hospital and continued through delivery.

OutcomesIntrapartum interventions, perceived control, method of delivery.
NotesEpidural analgesia was available and EFM was used routinely.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer-generated table of random numbers.
Allocation concealment (selection bias)Low riskRandomisation done over the phone by a third party who had no knowledge of the participant, but used the open table of random numbers.
Blinding (performance bias and detection bias)
All outcomes
Low risk

All participants blinded to the intervention. Control participants received prenatal and postpartum support (after the end of data collection); experimental participants received prenatal and intrapartum support.

Initial collection of medical record data was not blinded. 'Duplicate abstraction was done by a second research assistant blind to the subject's study group assignment, on a random sample of 20 records. Interrater agreement of over 95% was obtained for all categories of intervention and physical outcomes.' In-home interview at 2-4 weeks postpartum was blinded.

Incomplete outcome data (attrition bias)
All outcomes
Low riskMethod of delivery outcome available on 88.3% of sample. Other outcomes collected on only 71% of the sample and thus not used.
Selective reporting (reporting bias)Low riskAll outcomes were reported.
Other biasLow riskNo other sources of bias noted.

Hodnett 2002

MethodsMulti-centre RCT with prognostic stratification for parity and hospital.
Participants6915 nulliparous and parous women in labour at 13 hospitals in the USA and Canada (3454 to continuous labour support and 3461 to usual care). Eligibility criteria: live singleton fetus or twins, no contraindications to labour, in labour. Women were excluded if gestational age was < 34 weeks or if they were so high risk that a 1:1 patient-nurse ratio was medically necessary.
Interventions

Experimental: continuous support from staff labour and delivery nurses who had volunteered for and received a 2-day training workshop in labour support. Prior to the trial, the support nurses had opportunities to practice their skills. They also had opportunities to continue learning from each other and the labour support trainer, throughout the trial. The nurses with training were part of the regular staffing complement of the unit and they provided care to the continuous support group but not to the usual care group.

Usual care: intermittent support from a nurse who had not received labour support training.

OutcomesIntrapartum interventions, method of birth, immediate complications (mother or baby), complications (mother or baby) in the first 6-8 weeks postpartum, perceived control, postpartum depression, breastfeeding at 6-8 weeks, relationship with partner and with baby, likes and dislikes about birth experience and future preferences for labour support.
NotesOther support person(s) were allowed, epidural analgesia was available and EFM was used routinely.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputerised randomisation program.
Allocation concealment (selection bias)Low risk'Randomization was centrally controlled with the use of a computerized randomization program at the data co-ordinating centre, accessible by means of a touch-tone telephone.'
Blinding (performance bias and detection bias)
All outcomes
Low riskData collectors were not blinded as they read nurses' notes to collect data about type of nursing care provided. However random chart audits yielded no errors in reporting study outcomes.
Incomplete outcome data (attrition bias)
All outcomes
Low riskMedical record data were collected on 100% of the sample. In-hospital questionnaires were completed by 96.4% and 6-8 week questionnaires by 81% of the sample.
Selective reporting (reporting bias)Low riskAll outcomes were reported.
Other biasLow riskNo other sources of bias noted.

Hofmeyr 1991

MethodsRCT.
Participants189 nulliparous women (92 to support and 97 to control) in active labour at a community hospital serving low-income women in South Africa.
Interventions

Intervention group: support by carefully trained, volunteer lay women, for at least several hours (supporters not expected to remain after dark).

Control group: intermittent care on a busy ward. Husbands/family members were not permitted.

OutcomesIntrapartum interventions, method of birth, complications (mother and baby), anxiety, pain, mothers' perceptions of labour, breastfeeding.
NotesEpidural analgesia was not available and EFM was not used routinely. While scores on an instrument measuring postpartum depression were reported in categories of "low", "moderate," and 'high", the authors stated that categorization was not appropriate as a clinical diagnostic definition of depression.  To achieve the latter, the change in score must be reported, and these data were not collected.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandom.
Allocation concealment (selection bias)Unclear risk"Randomly ordered cards in sealed opaque envelopes". Not stated if consecutively numbered.
Blinding (performance bias and detection bias)
All outcomes
High riskData collectors were not blinded as they asked questions about support received in labour.
Incomplete outcome data (attrition bias)
All outcomes
Low riskMedical record data were collected on 100% of the sample and questionnaires within 24 hours postpartum were completed by 99%. The 6-week follow-up interviews were completed by 78.8% of the sample, no imbalances existed between groups and thus the data were included in the analysis. At 1-year interviews were complete for 46% of the sample and data from these were not used. Nikodem reported on a larger sample of women with 1-year follow-ups but the completion rate was still only 50% of the original number enrolled.
Selective reporting (reporting bias)Low riskAll outcomes were reported.
Other biasLow riskNo other sources of bias noted.

Kashanian 2010

MethodsRCT.
Participants100 nulliparous women at term (50 to support and 50 to routine care) in active labour at a university hospital in Tehran, Iran from March to September 2003.
Interventions

'Women allocated to the intervention group were shown to an isolated room and were supported by an experienced midwife. The women were free to choose their position, and able to eat and walk about freely. During labor, the midwife explained the process of labor and the importance of body relaxation. Midwife-led support included close physical proximity, touch, and eye contact with the labouring women, and teaching, reassurance, and encouragement. The midwife remained with the woman throughout labor and delivery, and applied warm or cold packs to the woman's back, abdomen, or other parts of the body, as well as performing massage according to each woman's request.'

'Women allocated to the routine care group were admitted to the labor ward (where 5-7 women labour in the same room), did not receive continuous support, and followed the routine orders of the ward. They did not have a private room, did not receive one-to-one care,were not permitted food, and did not receive education and explanation about the labor process. The only persons allowed in the delivery room were nurses, midwives, and doctors.'

OutcomesDuration of labour, caesarean delivery, oxytocin use, Apgar score at 5 mins.
NotesEFM was not used routinely and epidural analgesia was not available.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskFrom personal communication - equal numbers of envelopes were produced for each letter (see below) and put into a box. No list of treatment allocations was created.
Allocation concealment (selection bias)High risk

'Allocated to one of two groups using 4-part, block randomization'. Used 'sealed envelopes labelled A, B, C, and D: envelopes A and C (intervention group) and B and D (routine care group). Patients then chose an envelope, which was opened by the investigator'.

Further details from personal communication - the women picked from all the envelopes produced. Once an envelope was picked it was discarded.

This process was open to selection bias as women previously in the trial may have shared knowledge of which envelope contained which group with women not yet enrolled in the study.

Blinding (performance bias and detection bias)
All outcomes
Low riskFrom personal communication - 'The co worker of investigator collected the outcome data and she was blind for the study group.'
Incomplete outcome data (attrition bias)
All outcomes
Low riskMedical record information was collected on 100% of the sample.
Selective reporting (reporting bias)Low riskAll outcomes were reported.
Other biasLow riskNo other sources of bias noted.

Kennell 1991

MethodsRCT of continuous support vs usual care with an 'inconspicuous observer' plus a retrospective non-random control group. This review is restricted to comparisons of the outcomes of the participants who were randomly assigned.
Participants412 nulliparous women (212 in support group and 200 in observed group) were part of the RCT. They were aged 13-34, with singleton, term, healthy pregnancies, many not English-speaking, in active labour at a public hospital in Texas which provides care for low-income patients.
Interventions

The description of the setting, the participants, and the type of care echo developing world conditions. All women laboured in a large 12-bed room.

For the women in the support group a doula stayed by their bedside and gave continuous support.

For those in the observed group they had the routine intermittent presence of a nurse and continuous presence of an 'inconspicuous observer' who 'kept a record of staff contact, interaction and procedures'. The observer was away from the beside and never spoke to the labouring woman.

OutcomesAnalgesia/anaesthesia, labour length, artificial oxytocin use, method of birth, complications (mother and baby), neonatal health, number of women who rated their experience as negative.
Notes

In instances in which outcome data (such as analgesia/anaesthesia use) in the published report were only provided for subgroups, the primary author was contacted and he provided complete outcome data for all women who were originally randomised.

Family members were not allowed to be present. Epidural analgesia was available and EFM was used routinely.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskDescribed as random.
Allocation concealment (selection bias)Low risk'Randomly assigned' is stated in the report. In the protocol for the trial it states 'numbered opaque envelopes' would be used. The envelopes 'would contain the random assignments of the women to control or treatment groups and would be numbered sequentially'.
Blinding (performance bias and detection bias)
All outcomes
Unclear riskNot stated.
Incomplete outcome data (attrition bias)
All outcomes
Low riskThere is some discrepancy in the number of women enrolled in the study. The report states 412 were enrolled and reports outcome data on all 412 women. But it also states that '14 women that agreed to participate were not included in the study.' The reasons for not including them seem to be events that would happen after randomisation - e.g. transferred due to staffing limitations, withdrew, undetected breech, interrupted observations, etc., and thus the sample appears to have numbered 426. Data are reported for 412 women (96.7% of 426).
Selective reporting (reporting bias)Low riskAll outcomes were reported.
Other biasLow riskNo other sources of bias noted.

Klaus 1986

MethodsRCT. Purposefully enrolled more women to the control group. See 'Risk of bias' table below.
Participants465 healthy nulliparous women (186 to support group and 279 to control) in labour at the Social Security Hospital in Guatemala.
Interventions

Support group: continuous emotional and physical support by a doula.

Control group: usual hospital routines (described as no consistent support).

OutcomesLabour length, use of artificial oxytocin, method of birth, problems during labour and birth, fetal distress, Apgar scores, transfer to neonatal intensive care nursery.
NotesNo family members permitted to be present. epidural analgesia was not available and EFM was not used routinely.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk'Enrolled using randomised design'. 'Pool of envelopes contained more control group to ensure similar sized groups with uncomplicated labours and deliveries.' They anticipated more complications in control group based on an earlier study (Sosa 1980). No information on how allocation sequence was generated.
Allocation concealment (selection bias)Low risk'Randomly assigned according to contents of a sealed opaque envelope. Each envelope was numbered sequentially.'
Blinding (performance bias and detection bias)
All outcomes
Unclear riskNot noted.
Incomplete outcome data (attrition bias)
All outcomes
Low risk

'Mother-infant pairs were excluded when the mother developed a complication during labour, delivery, or post partum that required special care, if the baby's weight was below 5.5 lbs or above 8 lbs, if there were twins or congenital malformations.' This occurred for about 10% of cases in both groups resulting in reported outcomes for 89.6% of those randomised. Unpublished data on the excluded women were provided by the author.

Labour length data were only available for 48.4% of the sample (225 of 465) and thus not included.

Selective reporting (reporting bias)Low riskAll outcomes were reported on.
Other biasLow riskNo other sources of bias noted.

Langer 1998

MethodsRCT.
Participants724 women (361 to support and 363 to control) admitted for delivery at a large social security hospital in Mexico City, who met the following criteria: singleton fetus, no previous vaginal delivery, < 6 cm cervical dilatation, and no indications for an elective caesarean delivery.
Interventions

Support group: continuous support from 1 of 10 women who had received doula training (6 were retired nurses), throughout labour, birth, and the immediate postpartum period. Support included: emotional support, information, physical comfort measures, social communication, ensuring immediate contact between mother and baby after birth, and offering advice about breastfeeding during a single brief session postnatally.

Control group: women received 'routine care'.

OutcomesThe main outcomes were exclusive and full breastfeeding at 1 month postpartum. Other outcomes included labour length, epidural anaesthesia, forceps birth, caesarean birth, meconium staining, and Apgar scores, as well as mothers' perceived control during childbirth, anxiety, pain, satisfaction, and self-esteem.
NotesPartners and family members were not permitted. Epidural analgesia was available but it was not stated if EFM was used routinely.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk'Computer generated random number list'. 'The treatment sequence was kept at a central level.'
Allocation concealment (selection bias)Unclear risk'Opaque envelopes with the assignment were locked in a cabinet to which only a social worker exclusively in charge of randomisation and the principal investigator had access. An envelope with a paper inside showing to which group each woman was assigned was opened by the social worker immediately after recruitment in the labour and delivery unit. Not stated if envelopes were sequentially numbered.
Blinding (performance bias and detection bias)
All outcomes
Low riskData were collected by 2 'blinded social workers'.
Incomplete outcome data (attrition bias)
All outcomes
Low riskMedical record data and in-hospital interview data were collected for 100% of the sample. A in-home interview was completed at 1 month postpartum for 92.2% of the sample.
Selective reporting (reporting bias)Low riskAll outcomes were reported.
Other biasLow riskNo other sources of bias noted.

Madi 1999

MethodsRCT.
Participants109 Black women from Botswana (53 in support group and 56 in usual care group), mean age 19 years, 80% unmarried, mostly students, who had met the following criteria: nulliparous, in labour, pregnancy at term, no history of pregnancy complications, cephalic presentation, normal spontaneous labour with cervical dilation 1-6 cm, female relative present who was willing to remain with the woman for the duration of labour.
Interventions

Support group: continuous presence of female relative (usually her mother) in addition to usual hospital care.

Congrol group: usual hospital care, which involved staff:patient ratios of 1:4, and no companions permitted during labour.

OutcomesSpontaneous vaginal birth, vacuum extraction, caesarean birth, analgesia, amniotomy, artificial oxytocin during labour, Apgar scores (1- and 5-min).
NotesEpidural analgesia was not available and it was not stated whether EFM was used routinely.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk'Randomly allocated.' No other details provided.
Allocation concealment (selection bias)Low risk'Selection of an opaque, numbered, sealed envelope from a box of envelopes that were shuffled in the woman's presence. When opened the envelope revealed a code indicating her group.' An assistant that was not involved in the recruitment process shuffled the envelopes.
Blinding (performance bias and detection bias)
All outcomes
High riskThe researcher, who was involved in the recruitment of participants, collected the medical record data.
Incomplete outcome data (attrition bias)
All outcomes
Low riskMedical record data were collected on 100% of the sample.
Selective reporting (reporting bias)Low riskAll outcomes were reported.
Other biasLow riskNo other sources of bias noted.

McGrath 2008

MethodsRCT. Enrollment occurred at childbirth education classes and randomisation occurred when the woman arrived at hospital in labour.
Participants420 nulliparous middle and upper class women (224 on doula group and 196 in control group) were enrolled in the third trimester of an uncomplicated pregnancy in Cleveland, Ohio. All women expected to be accompanied during labour by their male partner.
Interventions

Experimental group: a doula met the couple at the hospital as soon as possible after random assignment (typically within an hour of their arrival at the hospital) and remained with them throughout labour and delivery. The central component of doula support was the doula’s continuous bedside presence during labour and delivery, although her specific activities were individualised to the needs of the labouring woman. Doula support included close physical proximity, touch, and eye contact with the labouring woman, and teaching, reassurance, and encouragement of the woman and her male partner. All doulas completed training requirements that were equivalent to the DONA International doula certification.

Control group: routine obstetric and nursing care which included the presence of a male partner or other support person.

OutcomesCaesarean delivery, epidural anaesthesia, oxytocin use, labour length, mode of delivery, fever during labour, satisfaction at 6 weeks postpartum.
Notes

Epidural analgesia was available and EFM was used routinely.

The author has been contacted for data split by study group and questionnaire data for the control group.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNo details stated.
Allocation concealment (selection bias)Low risk'When the research co-ordinator was informed that an enrolled woman had arrived at the hospital in early active labor, she opened the next sequentially numbered opaque envelope to determine random assignment to the doula or control group'. The research co-ordinator was off-site and called by the staff or the study participant.
Blinding (performance bias and detection bias)
All outcomes
Unclear riskNot stated.
Incomplete outcome data (attrition bias)
All outcomes
Low riskMedical record data were collected on 100% of the sample. The in-hospital and 6-week questionnaires were completed by 87.9% and 87.5% of the doula group. No information was provided for the control group.
Selective reporting (reporting bias)Low riskThe primary outcomes of caesarean birth and epidural anaesthesia were reported for each study group. Other labour and delivery outcomes were reported for the full sample only (not split by group). The in-hospital and 6-week questionnaire data were only reported for the doula group. The author has been contacted for these missing details.
Other biasLow riskNo other sources of bias noted.

Morhason-Bello 2009

MethodsRCT.
Participants603 women from Ibadan, Nigeria with anticipated vaginal delivery were enrolled between 30 and 32 weeks' gestation at an antenatal clinic (305 to intervention and 298 to control) from November 2006 to March 2007.
Interventions

Those in the experimental group were informed to bring someone of their choice to act as a companion during labour. On arrival in labour the accompanying companions were provided with an information leaflet that explained their responsibilities. These included: gentle massage of the woman’s back during contraction, reassuring words, spiritual support inform of prayers and also acting as intermediary between the woman and healthcare team. After studying the leaflets, they were allowed to seek clarifications. The information leaflet was also interpreted for those that are not literate. The attending midwife allowed and ensured companions performed their expected duties throughout. The companions were told to offer continuous support – they were to be by the patient’s side except for feeding and use of toilet until two hours after childbirth. Husbands were the most common support person (65.4%).

The women in the control group had only routine care where relatives of patients are usually barred from the labour ward.

OutcomesCaesarean section rate, active phase of labour duration, pain score, need for analgesia, need for oxytocin augmentation, time from delivery to initiation of breastfeeding and the emotional experience during labour.
Notes

Epidural analgesia was not available and it was not stated whether EFM was used routinely. We have requested further details from the authors.

The randomisation process was well done, but resulted in an imbalance in socioeconomic status between the groups. Women in the experimental group tended to be more educated (82% vs 48% with tertiary level) and skilled workers (78% vs 39%). This imbalance was noted and discussed by the authors.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk'The randomisation sequence was generated using a table of random numbers'.
Allocation concealment (selection bias)Low risk'Random permuted blocks of size four were used to ensure a balanced design.' 'Based on the sequence of treatments generated using this method, treatment groups (A and B) were written on pieces of cardboard paper and put into sealed opaque envelopes. Each of the opaque envelopes had a serial number on it.' 'Two trained research assistants (RAs) non-medical staff, supervised the randomisation procedure at every clinic. On each clinic day, consented women that met the inclusion criteria were given serial numbers with allotted treatment group based on their arrival time. Only the statistician and RAs had access to the list of numbers used to prevent clinicians’ influence on the randomisation. Each participant opened the opaque envelope in the presence of an RA, and the assigned treatment group was recorded on the woman’s medical record file.'
Blinding (performance bias and detection bias)
All outcomes
High riskHow data collection was done was not noted. The treatment group was noted in the chart so it is likely that the data collectors were unblinded.
Incomplete outcome data (attrition bias)
All outcomes
Low riskFollow-up was completed for 97% of the sample.
Selective reporting (reporting bias)Low riskAll outcomes were reported.
Other biasLow riskNo other sources of bias noted.

Thomassen 2003

MethodsRCT, no details regarding method of random assignment.
Participants144 'healthy' women having their first baby booked for delivery at a Swedish hospital (72 to doula group and 72 to usual care). Participants were enrolled at 36 weeks' gestation.
InterventionsContinuous presence by a doula who had met the woman during pregnancy, compared to usual care.
OutcomesEmergency caesarean birth and epidural analgesia.
Notes

The trial author reported that the information about randomisation method and outcomes of those lost to follow-up are no longer available.

Epidural analgesia was available. It was not stated if other support person(s) were allowed or if EFM was used routinely.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk"Randomized' - no further details provided or available.
Allocation concealment (selection bias)Unclear riskNo details provided or obtained.
Blinding (performance bias and detection bias)
All outcomes
Unclear riskNot noted.
Incomplete outcome data (attrition bias)
All outcomes
High riskMedical record data collected on 70.1% of sample. No usable outcome data, due to serious risk of attrition bias. Outcomes are reported for 55/72 (76%) of the intervention group and 46/72 (64%) of the control group. Reason for the 41 “dropouts” were preterm birth, induction, or caesarean section “for medical reasons”, and participant withdrawal. No numbers are given for individual reasons, or by group, but it is clear that some “dropouts” were prior to labour and others were during labour. Numbers in the report show the number of dropouts was actually 43.
Selective reporting (reporting bias)Unclear riskSample size was based on caesarean section rate. The only outcome reported was emergency caesarean.
Other biasHigh riskTrial was stopped early for 'a range of largely organizational issues' when only 1/4 of the original sample size had been enrolled.

Torres 1999

MethodsRCT.
Participants435 women (217 in companion group, 218 in control group) with a singleton pregnancy and considered to be low-risk at University Hospital in Santiago, Chile. Enrolled at 34-36 weeks' gestation.
Interventions

Intervention group: psychosocial support during labour from a companion chosen by the pregnant woman. The companions were trained by trial staff to provide emotional support, promote physical comfort and encourage progress of labour, without interfering with the activities of the obstetricians or midwives. They were with the labouring woman continuously from admission to delivery. Women were encouraged to pick a companion who had experienced a vaginal birth.

Control group did not have companion.

Both groups laboured in a room with other women where curtains were pulled for privacy.

OutcomesCaesarean section, exclusive breastfeeding, duration of labour, mode of delivery, use of oxytocics, presence of meconium, regional anaesthesia, birth asphyxia, Apgar scores, level of neonatal care, maternal satisfaction.
NotesEpidural analgesia was available. It was not stated if EFM was used routinely. Authors have been contacted for further details.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer-generated list of random numbers.
Allocation concealment (selection bias)Low riskUsed blocks of 6. Group assignment used sealed opaque envelopes numbered consecutively. A member of the trial team enrolled women and did not know in advance the content of each envelope.
Blinding (performance bias and detection bias)
All outcomes
Unclear riskNot stated.
Incomplete outcome data (attrition bias)
All outcomes
Low riskMedcial record data were collected for 100% of the sample and in-hospital surveys were completed by 95.8%. A 6-week phone interview was completed for 71.2% of the sample and thus these data were not used.
Selective reporting (reporting bias)Low riskAll outcomes were reported.
Other biasLow riskNo other sources of bias noted.

Yuenyong 2012

  1. a

    EFM: electronic fetal monitoring
    min: minutes
    NICU: neonatal intensive care unit
    RCT: randomised controlled trial
    SD: standard deviation
    vs: versus

MethodsRCT
Participants120 nulliparous women, ages 18-30, at least 36 weeks' gestation, singleton fetus with cephalic presentation, able and willing to have a close female relative with them during labour and birth, booked to give birth at a regional teaching hospital in Thailand.
InterventionsExperimental group: close female relative who attended a 2-hour preparation class on labour routines and supportive actions, and provided continuous support during the active portion of hospital labour. The institution required that the researcher remain in order to monitor the relative's activities. Control group: usual care by health professionals, which included intermittent support. Family members were not permitted to stay with the woman.
OutcomesOxytocin during labour, analgesia, labour length, spontaneous birth, assisted vaginal birth, caesarean birth, Apgar Scores, perceived control.
NotesEpidural analgesia was not available and continuous EFM was not used.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandom number sequence generated by a software program.
Allocation concealment (selection bias)Low riskSealed opaque envelopes were used. Envelopes were consecutively-numbered on the outside.
Blinding (performance bias and detection bias)
All outcomes
Low riskWomen, investigator, and providers could not be blinded to the presence of the female relative. Research assistant blinded to group assignment collected satisfaction data.
Incomplete outcome data (attrition bias)
All outcomes
Low risk5% lost to follow-up: 2 in the experimental group and 4 in the control group.
Selective reporting (reporting bias)Low riskAppears complete.
Other biasLow risk6 women (10%) in experimental group did not receive continuous support.

Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion
  1. a

    EFM: electronic fetal monitoring
    RCT: randomised controlled trial
    vs: versus

Bender 19682 studies are reported, n = 12 in the first study and n = 30 in the second. Neither one was an RCT. Both employed alternate allocation that was neither centrally controlled nor concealed. The researcher delivered the intervention and collected outcome data. In the first study the researcher also enrolled participants. No usable outcome data are reported.
Bochain 2000The intervention was not continuous labour support. It was a short nursing intervention (taking approximately 1 hour) administered in early labour for women undergoing Misoprostol induction.
Brown 2007The intervention was not continuous labour support. It was an educational intervention to promote childbirth companions in hospital deliveries. A cluster-RCT was undertaken at 10 South African state maternity hospitals.
Dalal 2006Not an RCT. 100 randomly-selected mothers who had a birth companion were compared with 50 randomly-selected mothers who did not have one. Mothers were matched for age and socioeconomic status.
Gordon 199930% of those enrolled were excluded post-randomisation, 73/232 in the doula group and 69/246 in the control group. A letter was sent to the first author, asking for data on the excluded participants that would permit an intent-to-treat analysis. If and when a response is received, we will evaluate the trial report again.
Hemminki 1990cThird study in the same report as Hemminki 1990aand Hemminki 1990b. This was a small pilot RCT of support by laywomen that was 'stopped for economic and other practical reasons'. 31 women were enrolled but 7 dropped out (all from the intervention group). Very little data were reported and it was not separated by treatment group and thus unusable.
Lindow 1998Support was not continuous, and was quite brief in duration. 16 women in active labour were randomised to either 1 hour with a supportive companion or 1 hour without. The only outcome was maternal oxytocin level for 16 minutes post-support or control period.
McGrath 1999An abstract outlining a study of 531 women in Houston, Texas. Insufficient details to permit evaluation of the quality of the trial, and insufficient details regarding results. Thus far, attempts to locate a full report of the trial have been unsuccessful.
Orenstein 1998Not a randomised trial. Women chose to either have a doula or have Lamaze preparation for childbirth.
Pinheiro 1996An abstract of a paper presented at the Xth World Congress of Psychiatry in Madrid, 1996. Preliminary results were reported. Efforts to locate a published report of the full trial have been unsuccessful. The abstract provides insufficient details regarding methods, to permit evaluation of the quality of the trial. The purpose was to compare the effectiveness of female vs male doulas vs routine care without doulas. The doulas were medical and psychology students.
Ran 2005Not an RCT. Translated personal communication from the author stated "I randomly sampling allocated the patient, did not use any random tool".
Scott 1999Not a trial. A review of selected studies of intrapartum support.
Sosa 1980Strong evidence of selection bias. "A woman was removed from the study if labor was false or prolonged; if fetal distress necessitated an intervention such as oxytocin, caesarean delivery, or forceps"; or if the infant was asphyxiated or ill at birth, etc. "If a woman was removed, her group assignment was inserted at random into the pool of unused assignments. Women were enrolled in the study until there were 20 in the control group and 20 in the experimental group." The total study sample of 127 mothers includes 95 in the control group and 32 in the experimental group. Thus assignment was not random.
Trueba 2000Direct contact with investigator revealed that randomisation was not used. On arrival at the hospital, women were asked if they wanted to have a doula. If they accepted, a doula was assigned to them. Also support was not continuous throughout active labour for most women, since admission to the labour ward (and assignment of a doula) did not usually occur until 8 cm.
Tryon 1966Not an RCT. "After a random start, the matched groups were alternately assigned to experimental and control groups." Women who developed severe complications in labour (number not specified), such as fetal distress, were dropped from the study.
Zhang 1996Not a trial of continuous 1-to-1 support. On admission to the labour ward, women received instruction about normal labour, non-pharmacological methods to ease pain, and how to push in second stage, from a team of physicians and nurses. Support was continuous, depending on the women's needs, but not 1-to-1.

Characteristics of studies awaiting assessment [ordered by study ID]

Dong 2009

MethodsInsufficient details.
ParticipantsInsufficient details.
InterventionsInsufficient details.
OutcomesInsufficient details.
NotesAbstract - insufficient details to permit classification.

Huang 2003

MethodsInsufficient details.
ParticipantsInsufficient details.
InterventionsUnclear.
OutcomesInsufficient details.
NotesCommunication sent to author regarding details of randomisation process, the nature of the intervention, and information to allow classification for analysis subgroups.

Orbach-Zinger 2012

MethodsInsufficient details.
ParticipantsInsufficient details.
InterventionsInsufficient details.
OutcomesInsufficient details.
NotesAbstract - insufficient details to permit classification.

Riley 2012

MethodsInsufficient details.
ParticipantsInsufficient details.
InterventionsInsufficient details.
OutcomesInsufficient details.
NotesAbstract - insufficient details to permit classification.

Safarzadeh 2013

MethodsInsufficient details.
ParticipantsInsufficient details.
InterventionsInsufficient details.
OutcomesInsufficient details.
NotesAbstract - insufficient details to permit classification.

Sangestani

MethodsInsufficient details.
ParticipantsInsufficient details.
InterventionsInsufficient details.
OutcomesInsufficient details.
NotesAbstract - insufficient details to permit classification.

Shen

MethodsInsufficient details.
ParticipantsInsufficient details.
InterventionsInsufficient details.
OutcomesInsufficient details.
NotesAbstract - insufficient details to permit classification.

Wan 2011

MethodsInsufficient details.
ParticipantsInsufficient details.
InterventionsInsufficient details.
OutcomesInsufficient details.
NotesAbstract - insufficient details to permit classification.

Characteristics of ongoing studies [ordered by study ID]

Janssen

Trial name or titleJanssen.
MethodsInsufficient details.
ParticipantsInsufficient details.
InterventionsInsufficient details.
OutcomesInsufficient details.
Starting dateInsufficient details.
Contact informationInsufficient details.
Notes 

Ancillary