Acupuncture for induction of labour

  • Conclusions changed
  • Review
  • Intervention

Authors

  • Caroline A Smith,

    Corresponding author
    1. University of Western Sydney, Center for Complementary Medicine Research, Sydney, New South Wales, Australia
    • Caroline A Smith, Center for Complementary Medicine Research, University of Western Sydney, Locked Bag 1797, Sydney, New South Wales, 2751, Australia. caroline.smith@uws.edu.au.

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  • Caroline A Crowther,

    1. The University of Adelaide, ARCH: Australian Research Centre for Health of Women and Babies, The Robinson Institute, Discipline of Obstetrics and Gynaecology, Adelaide, South Australia, Australia
    2. The University of Auckland, Liggins Institute, Auckland, New Zealand
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  • Suzanne J Grant

    1. University of Western Sydney, Center for Complementary Medicine Research, Sydney, New South Wales, Australia
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Abstract

Background

This is one of a series of reviews of methods of cervical ripening and labour induction using standardised methodology. The use of complementary therapies is increasing and some women look to complementary therapies during pregnancy and childbirth to be used alongside conventional medical practice. Acupuncture involves the insertion of very fine needles into specific points of the body. The limited observational studies to date suggest acupuncture for induction of labour appears safe, has no known adverse effects to the fetus, and may be effective. However, the evidence regarding the clinical effectiveness of this technique is limited.

Objectives

To determine the effectiveness and safety of acupuncture for third trimester cervical ripening or induction of labour.

Search methods

We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (23 November 2012), PubMed (1966 to 23 November 2012), Embase (1980 to 23 November 2012), Dissertation Abstracts (1861 to 23 November 2012), CINAHL (1982 to 23 November 2012), the WHO International Clinical Trials Registry Portal (ICTRP) (23 November 2012) and bibliographies of relevant papers.

Selection criteria

Clinical trials comparing acupuncture used for third trimester cervical ripening or labour induction with placebo/no treatment or other methods listed above it on a predefined list of labour induction methods.

Data collection and analysis

Two review authors independently assessed trials for inclusion, evaluated methodological quality and extracted data.

Main results

The original review included three trials and seven trials were excluded. This updated review includes 14 trials, and excludes eight trials. Three trials previously excluded due to no clinically relevant outcomes are now included. Eight new trials were included, and four new trials were excluded. We included 14 trials with data reporting on 2220 women.

Trials reported on three primary outcomes only caesarean section, serious neonatal morbidity and maternal mortality. No trial reported on vaginal delivery not achieved within 24 hours; and uterine hyperstimulation with fetal heart rate (FHR) changes. There was no difference in caesarean deliveries between acupuncture and the sham control (average risk ratio (RR) 0.95, 95% confidence interval (CI) 0.69 to 1.30, six trials, 654 women), and acupuncture versus usual care (average RR 0.69, 95% CI 0.40, 1.20, six trials, 361 women). There was no difference in neonatal seizures between acupuncture and the sham group (RR 1.01, 95% CI 0.06 to 16.04, one trial, 364 women).

There was some evidence of a change in cervical maturation for women receiving acupuncture compared with the sham control, (mean difference (MD) 0.40. 95%CI 0.11 to 0.69, one trial, 125 women), and when compared with usual care (MD 1.30, 95% CI 0.11 to 2.49, one trial, 67 women). The length of labour was shorter in the usual care group compared with acupuncture (average standardised mean difference (SMD) 0.67, 95% CI 0.18 to 1.17, one trial 68 women). There were no other statistically significant differences between groups. Few studies reported on many clinically relevant outcomes. One trial was at a low risk of bias on all domains.

Authors' conclusions

Overall, there have been few studies assessing the role of acupuncture for induction of labour. Before implications for clinical practice can be made there is a need for well-designed randomised controlled trials to evaluate the role of acupuncture to induce labour and for trials to assess clinically meaningful outcomes.

Résumé scientifique

L'acupuncture pour le déclenchement du travail

Contexte

Cette revue fait partie d'une série de revues des méthodes de maturation cervicale et de déclenchement du travail à l'aide d'une méthodologie standardisée. L'utilisation de traitements complémentaires est en augmentation et certaines femmes se tournent vers des thérapies complémentaires pendant la grossesse et l'accouchement pour être utilisées en association avec la pratique médicale conventionnelle. L'acupuncture consiste à l'insertion d'aiguilles très fines dans des points spécifiques du corps. Les études observationnelles limitées réalisées à ce jour indiquent que l'acupuncture pour le déclenchement du travail semble sûre, n'a pas d'effets indésirables connus pour le fœtus, et pourrait être efficace. Cependant, les preuves concernant l'efficacité clinique de cette technique sont limitées.

Objectifs

Déterminer l'efficacité et l'innocuité de l'acupuncture pour la maturation cervicale pendant le troisième trimestre ou le déclenchement du travail.

Stratégie de recherche documentaire

Nous avons effectué des recherches dans le registre des essais cliniques du groupe Cochrane sur la grossesse et la naissance (23 novembre 2012), PubMed (de 1966 jusqu'au 23 novembre 2012), Embase (de 1980 jusqu'au 23 novembre 2012), Dissertation Abstracts (de 1861 au 23 novembre 2012), CINAHL (de 1982 jusqu'au 23 novembre 2012), WHO International Clinical Trials Registry Portal (ICTRP) (23 novembre 2012) et les bibliographies des articles pertinents.

Critères de sélection

Des essais cliniques comparant l'acupuncture utilisée pour la maturation cervicale pendant le troisième trimestre ou le déclenchement du travail à un placebo/ une absence de traitement ou à d'autres méthodes mentionnées dans une liste prédéfinie de méthodes de déclenchement du travail.

Recueil et analyse des données

Deux auteurs de la revue ont indépendamment évalué les essais à inclure, évalué la qualité méthodologique et extrait les données de manière indépendante.

Résultats principaux

La revue initiale avait inclus trois essais et sept essais avaient été exclus. Cette revue mise à jour inclut 14 essais, et exclut huit essais. Trois essais précédemment exclus en raison de l'absence de critères de jugement cliniquement pertinents sont désormais inclus. Huit nouveaux essais ont été inclus, et quatre nouveaux essais ont été exclus. Nous avons inclus 14 essais avec des comptes-rendus de données sur 2 220 femmes.

Les essais n'ont rendu compte que seulement de trois critères de jugement principaux que sont la césarienne, la morbidité néonatale grave et la mortalité maternelle. Aucun essai ne documentait d'accouchement non conclus par voie basse dans les 24 heures et d'hyperstimulation utérine avec des modifications de la fréquence cardiaque fœtale (FCF) . Il n'y avait aucune différence en termes d'accouchements par césarienne entre l'acupuncture et le groupe témoin sous acupuncture fantôme (risque relatif moyen (RR) 0,95, intervalle de confiance (IC) à 95 % 0,69 à 1,30 ; six essais, 654 femmes), et l'acupuncture par rapport à des soins habituels (RR moyen 0,69, IC à 95 % de 0,40 à 1,20, six essais, 361 femmes). Il n'y avait aucune différence dans les convulsions néonatales entre l'acupuncture et le groupe sous acupuncture fantôme (RR 1,01, IC à 95 % 0,06 à 16.04, un essai, 364 femmes).

Il y avait certaines preuves d'un changement dans la maturation cervicale pour les femmes recevant de l'acupuncture par rapport au groupe témoin sous acupuncture fantôme (différence moyenne (DM) 0.40. IC à 95 % 0,11 à 0,69, un essai, 125 femmes), et par rapport aux soins habituels (DM de 1,30, IC à 95 % 0,11 à 2,49, un essai, 67 femmes). La durée du travail était plus courte dans le groupe de soins habituels par rapport à l'acupuncture (moyenne de la différence moyenne standardisée (DMS) 0,67, IC à 95 % 0,18 à 1,17, un essai 68 femmes). Il n'y avait aucune autre différence statistiquement significative entre les groupes. Peu d'études avaient rendu compte de nombreux critères de jugement cliniquement pertinents. Un essai présentait un faible risque de biais pour tous les domaines.

Conclusions des auteurs

globalement, il y a eu peu d'études évaluant le rôle de l'acupuncture dans le déclenchement du travail. avant que des implications pour la pratique clinique puissent être émises il est nécessaire de réaliser des essais contrôlés randomisés bien conçus pour évaluer le rôle de l'acupuncture pour déclencher le travail et d'essais pour évaluer les critères de résultat cliniquement significatifs.

アブストラクト

分娩誘発に対する鍼療法

背景

本レビューは、標準化された方法を用いた子宮頸管熟化および分娩誘発の手法を集積したレビューの一つである。補完療法の使用は徐々に拡大し、妊娠中また出産時に、補完療法を従来の医療と併用することに関心を寄せる女性もいる。鍼療法は非常に細い鍼を体の特定点に刺入する。これまでの限られた観察研究では、分娩誘発に対する鍼療法は安全であるとし、胎児への有害作用の報告はなく、有効である可能性を示唆している。しかし、この手法の臨床的有効性に関するエビデンスは限られている。

目的

分娩第3期の子宮頸管熟化および分娩誘発に対する鍼療法の有効性と安全性を検討する。

検索戦略

Cochrane Pregnancy and Childbirth Group’s Trials Register(2012年11月23日)、PubMed(1966〜2012年11月23日)、Embase(1980〜2012年11月23日)、Dissertation Abstracts(1861〜2012年11月23日)、CINAHL(1982〜2012年11月23日)、WHO国際臨床試験登録プラットフォーム(ICTRP)(2012年11月23日)、関連性のある文献を検索した。 http://apps.who.int/trialsearch/

選択基準

分娩第3期の子宮頸管熟化および分娩誘発に対する鍼療法とプラセボ/無治療または事前定義した分娩誘発法リストで挙げられている別の方法とを比較する臨床試験。

データ収集と分析

2名のレビュー著者が独立して臨床試験の選択基準を評価し、研究手法の質を検討し、データを抽出した。

主な結果

オリジナルのレビューで3件の試験を対象とし、7件の試験を除外した。この更新レビューでは14件の試験を対象とし、8件の試験を除外した。臨床的に関連のないアウトカムであるため前回除外した3件の試験を今回は対象とした。8件の新たな試験を対象とし、4件の新たな試験を除外した。女性2220例の報告データを含む14件の試験を対象とした。

試験は、帝王切開、新生児の重篤な罹患率、妊婦の死亡率の3つの主要なアウトカムのみの報告であった。24時間以内の経膣分娩未達成、および胎児心拍数(FHR)変化のある子宮過剰刺激を報告した試験はなかった。帝王切開に対する鍼療法と偽鍼療法との比較に差はみられず(平均リスク比(RR)0.95、95%信頼区間(CI)0.69〜1.30、6件の試験、女性654名)、鍼療法と通常ケアとの比較に差はみられなかった(平均RR 0.69、95%CI 0.40、1.20、6件の試験、女性361名)。新生児痙攣に対する鍼療法と偽鍼療法との間に差はみられなかった(RR1.01、95%CI 0.06〜16.04、1件の試験、女性364名)。

鍼療法を受けた女性は、偽鍼療法と比較して子宮頸管熟化における変化のエビデンスがみられ(平均差(MD)0.40 95%CI 0.11〜0.69、1件の試験、女性125名)、通常ケアと比較しても変化のエビデンスがみられた(MD1.30、95%CI 0.11〜2.49、1件の試験、女性67名)。分娩の長さは、鍼療法と比較して標準ケア群が短かった(標準化平均差(SMD)0.67、95%CI 0.18〜1.17、1件の試験、女性68名)。群間でその他の統計学的な有意差はみられなかった。臨床的関連性が多くある結果を報告した研究はほとんどない。1件の試験では、すべての領域においてバイアスのリスクが低かった。

著者の結論

総じて分娩誘発に対する鍼療法の役割を対象とした研究はほとんどない。臨床診療のための関連事項をまとめる前に、分娩誘発に対する鍼療法の役割を評価するためのよくデザインされたランダム化比較試験や、臨床的に意義のあるアウトカムを評価する試験を行う必要がある。

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/)[2015.12.28]《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

Acupuncture for induction of labour

There is insufficient evidence describing the efficacy of acupuncture to induce labour.

Sometimes it is necessary to bring on labour artificially because of safety concerns for the mother or baby. Induction of labour (getting labour started artificially) is common when the pregnancy is posing a risk. Various methods of preparing the cervix of the uterus and inducing labour are available to the pregnant woman or her unborn child. Some women look to complementary therapies during pregnancy and childbirth to be used alongside conventional medical practice.

Acupuncture is the insertion of fine needles into specific points of the body and has been used to help ripen the cervix, induce labour and reduce labour pains. The review included 14 trials with data reporting on 2220 women randomised to receive acupuncture compared with sham acupuncture or usual care. Most trials were from Western countries, with only two from Asia. The evidence regarding the clinical effectiveness of this technique was limited. No trial reported on vaginal delivery not achieved within 24 hours, uterine hyperstimulation with fetal heart rate changes, and serious maternal illness or death. Caesarean deliveries and neonatal seizures were no different. The trials used different acupuncture points, number of treatments and methods of acupuncture, (manual or electro-acupuncture). More research is needed.

Résumé simplifié

L'acupuncture pour le déclenchement du travail

Il n'existe pas suffisamment de données décrivant l'efficacité de l'acupuncture pour déclencher le travail.

parfois il est nécessaire de déclencher artificiellement le travail en raison d'inquiétudes relatives à la mère ou au bébé. Le déclenchement du travail (le déclenchement du travail par des moyens artificiels) est chose courante lorsque la grossesse présente des risques. Diverses méthodes de préparation du col de l'utérus et de déclenchement du travail sont disponibles pour la femme enceinte ou son enfant à naître. Certaines femmes se tournent vers des thérapies complémentaires pendant la grossesse et l'accouchement pour être utilisées en association avec la pratique médicale conventionnelle.

L'acupuncture consiste à insérer de fines aiguilles dans des points spécifiques du corps et a été utilisée pour aider à la maturation du col de l'utérus, au déclenchement du travail et à la réduction des douleurs ressenties pendant le travail. La revue a inclus 14 essais avec des comptes-rendus de données sur 2 220 femmes randomisées pour recevoir l'acupuncture par rapport à une acupuncture simulée ou à des soins habituels. La plupart des essais provenaient de pays occidentaux, avec seulement deux en Asie. Les preuves concernant l'efficacité clinique de cette technique étaient limitées. Aucun essai ne documentait d'accouchement non conclus par voie basse dans les 24 heures, l'hyperstimulation utérine avec des modifications du rythme cardiaque fœtal, et les maladies graves ou les décès de la mère. Les Accouchements par césarienne et les convulsions néonatales n'étaient pas différents. Les essais différaient sur les points d'acupuncture, le nombre de traitements et les méthodes d'acupuncture, (manuelle ou électro-acupuncture). Des recherches supplémentaires sont nécessaires.

Notes de traduction

Traduit par: French Cochrane Centre 5th November, 2013
Traduction financée par: Ministère du Travail, de l'Emploi et de la Santé Français

Laienverständliche Zusammenfassung

Akupunktur zur Geburtseinleitung

Die Wirksamkeit von Akupunktur zur Geburtseinleitung ist nicht ausreichend wissenschaftlich belegt.

Manchmal ist es für die Sicherheit von Mutter oder Kind notwendig, die Geburt einzuleiten. Eine Geburtseinleitung (künstliche Wehenanregung) wird üblicherweise durchgeführt, wenn die Schwangerschaft ein Risiko darstellt. Für die schwangere Frau und ihr ungeborenes Kind stehen verschiedene Methoden zur Verfügung, um den Muttermund vorzubereiten und die Geburt einzuleiten. Manche Frauen suchen während der Schwangerschaft und der Geburt nach komplementären Behandlungsmethoden, die neben schulmedizinischen Angeboten genutzt werden.

Bei der Akupunktur werden feine Nadeln in spezifische Punkte des Körpers eingestochen. Sie wird angewendet, um das Reifen des Muttermundes zu unterstützen, die Geburt einzuleiten und den Geburtsschmerz zu mindern. In den Review wurden 14 Studien mit Daten von 2220 Frauen eingeschlossen, die randomisiert entweder Akupunktur, Placebo-Akupunktur oder die allgemein übliche Behandlung erhielten. Außer zwei Studien aus Asien wurden die meisten Studien in westlichen Ländern durchgeführt. Die Evidenz für die klinische Alltagswirksamkeit dieser Behandlung war eingeschränkt. Keine der Studien berichtete über vaginale Geburt innerhalb von 24 Stunden, Überstimulation der Gebärmutter mit Veränderungen der kindlichen Herztöne und schwere mütterliche Erkrankungen oder Tod. In Hinblick auf die Rate der Kaiserschnitte und der Krampfanfälle bei Neugeborenen zeigten sich keine Unterschiede. In den Studien kamen verschiedene Akupunkturpunkte, eine unterschiedliche Anzahl an Behandlungen und Methoden der Akupunktur (manuelle oder Elektroakupunktur) zur Anwendung. Weitere Forschung ist notwendig.

Anmerkungen zur Übersetzung

C. Loytved, A. Stiefel, Koordination durch Cochrane Schweiz.

平易な要約

分娩誘発に対する鍼療法

分娩誘発に対する鍼療法の有効性に関するエビデンスは十分ではない。

母子に関する安全性を考慮すると、時に分娩を人工的に誘発させる必要がある。分娩誘発(分娩を人工的に引き起こすこと)は、妊娠状態が危険をもたらす際に頻度が高い。妊婦または胎児のための子宮頸部を熟化し分娩を誘発する方法はさまざまある。妊娠中また出産時に、補完療法を従来の医療と併用することに関心を寄せる女性もいる。

細い鍼を体の特定点に刺入する鍼療法は、子宮頸管熟化、分娩誘発、陣痛の軽減に用いられている。レビューは、女性2220名が鍼療法、偽鍼療法、または通常ケアに無作為に割り付けられた14件の試験のデータを対象とした。ほとんどの試験は西洋の国々で、アジアからは2カ国のみであった。この手法における臨床的有効性に関するエビデンスは限られていた。24時間以内の経膣分娩未達成、胎児心拍数変化のある子宮過剰刺激、重篤な母体疾患または死亡の報告がある試験はなかった。帝王切開、新生児痙攣では差がみられなかった。試験では異なる鍼療法の経穴、治療回数、鍼の方法(マニュアル鍼または電気鍼)を用いた。 今後もさらなる研究が必要である。

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/)[2015.12.28]《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。

쉬운 말 요약

분만 유도를 위한 침 치료

분만 유도를 위한 침 치료의 효능 근거는 불충분하다.

때때로 산모나 태아의 안전을 위해 인공 분만이 필요하다. 유도 분만 (인공적인 분만 시도) 은 고위험 분만이 우려될 때 흔히 이루어진다. 산모와 태아를 위한 다양한 방식의 자궁 경부 준비 및 분만 유도법이 존재한다. 산모들 중 일부는 임신 및 출산 중 서양의학적 치료와 병행 사용하기 위한 보완 요법을 찾는다.

침은 경혈에 가는 바늘 형태의 호침을 자입하는 치료이며, 자궁 경부의 이완을 돕고 분만을 유도하며 출산 시 통증을 줄이기 위해 사용되어 왔다. 본 리뷰는 침 치료군과 거짓 침 치료군/일상관리군으로 여성들을 무작위 배정한 14건의 임상시험 (2220명의 여성) 을 분석하였다. 대부분의 임상시험은 서구에서 수행되었으며, 단 두 건만이 아시아에서 이루어졌다. 침 치료의 임상적 효과에 대한 근거는 제한적이었다. 어떠한 임상시험에서도 24시간 이내 질 분만 실패, 태아 심박수 변화가 동반된 자궁 과다자극, 산모의 심각한 질환 및 사망에 대해 보고하지 않았다. 제왕절개 및 신생아 발작 발생 측면에서는 침 치료와 대조 치료 간 차이가 없었다. 임상시험에서 사용한 침 치료법들은 사용한 경혈, 치료 횟수, 침 자극 방법 (수기 자극 또는 전기 자극) 측면에서 서로 달랐다. 더 많은 연구가 필요하다.

역주

이 번역은 김건형 (부산대학교 한의학전문대학원; pdchrist@gmail.com) 이 작성하였습니다. 번역 내용과 관련한 문의는 위 메일로 주시기 바랍니다.

Background

Description of the condition

Sometimes it is necessary to bring on labour artificially because of safety concerns for the mother or baby. This review is one of a series of reviews of methods of labour induction using a standardised protocol. For more detailed information on the rationale for this methodological approach, please refer to the currently published 'generic' protocol (Hofmeyr 2000). The generic protocol describes how a number of standardised reviews will be combined to compare various methods of preparing the cervix of the uterus and inducing labour.

Description of the intervention

The use of complementary and alternative medicine (CM) has become popular with consumers worldwide. Studies suggest that between 36% and 62% of adults in industrialised nations use some form of CM to prevent or treat health-related problems (Barnes 2004). A recent review of 14 studies with large sample sizes (N > 200) on the use of CM in pregnancy identified a prevalence rate ranging from1% to 87% (with nine falling between 20% and 60%) (Adams 2009). The review identified use of various complementary therapies including acupuncture and acupressure, aromatherapy, massage, yoga, homeopathy and chiropractic care. The review also showed many pregnant women had used more than one complementary product or service (Adams 2009). In Europe, between 12% and 19% of the population report using acupuncture, according to consumer surveys (Fisher 1994). Some women look to alternative therapies during pregnancy and childbirth to be used alongside conventional medical practice. A recent survey described the prevalence and use of complementary therapies among 82 nurse-midwives in North Carolina (Allaire 2000). Almost 20% of nurse-midwives reported use of acupuncture during pregnancy, with 6% of responders specifically recommending its use to ripen the cervix (the process of softening and dilating the cervix) and/or induce labour. In the same survey, 27 respondents (33%) reported using herbal therapies for labour stimulation. For some women with a prolonged pregnancy, an induction of labour may be perceived to intervene in the natural process of pregnancy and may drastically change their expected plan of care during pregnancy. The reasons why pregnant women are interested in using complementary therapies to ripen the cervix and/or induce labour is an important question and needs to be answered when evaluating new options of care.

Acupuncture has been used for more than two thousand years in China and Japan. The diagnosis and treatment prescribed by traditional Chinese medicine (TCM) is influenced by the systems of medicine and philosophy of ancient China. Acupuncture involves the insertion of fine needles into the skin and underlying tissues at precise points on the body. The needle can be left alone or stimulated by turning in various ways or stimulated by electricity. Electro-acupuncture involves the use of electricity to stimulate the acupuncture point. To do this a needle is inserted and a terminal is attached to the handle, the other terminal is connected to a second needle or neutral electrode. Over time, different styles of acupuncture have been practiced by acupuncturists. Acupuncture treatment is composed of needling aspects (choice or points and needling techniques), specific components relating to the style of diagnosis and treatment used, and generic non-specific needling components not specific to acupuncture such as belief, time and attention given to the patient.

In parts of Europe and Asia acupuncture has been described as a method to alleviate labour pains, and ripen the cervix. More recently it has been used to stimulate the onset of labour.

Three case series document the role of acupuncture for the induction of labour (Tsuei 1974; Tsuei 1977; Yip 1976). Induction of labour using electro-acupuncture has been reported by Yip 1976. Labour was successfully induced in 21 of the 31 women, with pregnancy duration ranging from 38 to 42 weeks. The pattern of uterine activity was similar to that of normal labour. In a second study acupuncture with and without electrical stimulation was used to induce labour in 12 pregnant women with a gestational age from 19 to 43 weeks (Tsuei 1974). The success rate was 83% and average induction to delivery time was 13.1 hours. In the third study, 34 term and post term women and seven women with an intrauterine fetal death were induced using electro-acupuncture. Labour was successfully induced in 32 (78%) women (Tsuei 1977). The limited observational studies to date suggest acupuncture for induction of labour appears safe, has no known adverse effects to the fetus, and may be effective.

Two non-randomised trials have examined whether acupuncture could initiate contractions in women at term (Kubista 1975: Theobald 1973). In the trial by Theobald (Theobald 1973), four electrodes were applied to the skin of the abdomen to induce labour in the treatment group. Treatment was given to 27 women and compared with 102 women who were controls. In the treatment group 20 (77%) women gave birth on or up to four days before the estimated date of confinement, compared with 47 (46%) in the control group. In the second trial, electro-acupuncture was administered to 35 women, and 35 women received no electro-acupuncture. An increase in the intensity of labour contraction frequency was observed in 31 women in the treatment group. In the control group, no increase in labour activity was observed (Kubista 1975).

How the intervention might work

The mechanism underlying acupuncture to induce labour is speculative at this stage but may involve stimulation of the uterus by hormonal changes or by the nervous system. In animal studies low frequency electrical stimulation of the neuro-hypophyseal system induces the secretion of oxytocin. Parasympathetic stimulation close to term has been shown to have an influence on the uterus (Bell 1972). Stimulation of acupuncture points is known to increase the discharge of thalamic nuclei and the hypothalamic anterior pituitary system (Liao 1979). It is hypothesised that acupuncture neuronal stimulation may increase uterine contractility either by central oxytocin release or by parasympathetic stimulation of the uterus (Tempfeer 1998), without influencing locally active factors such as IL-8 and PGF2 either by central oxytocin release or by parasympathetic stimulation of the uterus (Tempfeer 1998).

Why it is important to do this review

Consumers generally perceive complementary medicine to be more natural than conventional medicine and have fewer concerns about side-effects. There are reports in the literature of rare adverse reactions to acupuncture, for example pneumothorax, infection or cardiac injury (Yamashita 1999). The general advice for the treatment of conditions arising during pregnancy is to exercise caution particularly during the first trimester of pregnancy, and to avoid some acupuncture points which may stimulate uterine activity. Treatment during the third trimester of pregnancy is thought to carry a lower risk.

This review is one of a series of reviews of methods of labour induction using a standardised protocol. For more detailed information on the rationale for this methodological approach please refer to the currently published protocol (Hofmeyr 2009).

Objectives

To determine, from the best available evidence, the effectiveness and safety of acupuncture for third trimester cervical ripening or induction of labour.

Methods

Criteria for considering studies for this review

Types of studies

Clinical trials comparing acupuncture for cervical ripening or labour induction, with placebo/no treatment, sham acupuncture or other methods listed above it on a predefined list of methods of labour induction; the trials included some form of random allocation to either group; and they reported one or more of the pre-stated outcomes.

The control group in a trial of acupuncture can involve sham (mock) acupuncture where the needles are inserted away from the usual location, with the depth and needle stimulation being the same. Or alternatively, minimal acupuncture which involves needles being inserted away from the usual location, with very shallow needling and very slight stimulation, or the use of the non invasive placebo needle (Streitberger 1998).

Types of participants

Pregnant women due for third trimester induction of labour, carrying a viable fetus. We planned to use subgroup analysis for any possible differences in the effect of interventions in these groups.

Types of interventions

Acupuncture compared with placebo, no treatment, sham acupuncture or any other method above it on a predefined list of methods of labour induction, as detailed below.

To avoid duplication of data in a series of reviews on interventions for labour induction, the labour induction methods were listed in a specific order, from one to 27, as outlined below. The methods for these reviews are described in the generic protocol for cervical ripening and labour induction in late pregnancy (Hofmeyr 2009). Each review included comparisons between one of the methods (from two to 26) with only those methods above it on the list.

Thus, this review of acupuncture (20) could include comparisons with any of the following: (1) placebo/no treatment; (2) vaginal prostaglandins; (3) intracervical prostaglandins; (4) intravenous oxytocin; (5) amniotomy; (6) intravenous oxytocin with amniotomy; (7) vaginal misoprostol; (8) oral misoprostol; (9) mechanical methods including extra-amniotic Foley catheter; (10) membrane sweeping; (11) extra-amniotic prostaglandins (12) intravenous prostaglandins; (13) oral prostaglandins; (14) mifepristone; (15) oestrogens with or without amniotomy; (16) corticosteroids; (17) relaxin; (18) hyaluronidase; (19) castor oil, bath, and/or enema.

The current list is as follows:

(1) placebo/no treatment;
(2) vaginal prostaglandins (Kelly 2009);
(3) intracervical prostaglandins (Boulvain 2008);
(4) intravenous oxytocin (Alfirevic 2009);
(5) amniotomy (Bricker 2000);
(6) intravenous oxytocin with amniotomy (Howarth 2001; Bimbashi 2012);
(7) vaginal misoprostol (Hofmeyr 2010);
(8) oral misoprostol (Alfirevic 2006);
(9) mechanical methods including extra-amniotic Foley catheter (Jozwiak 2012);
(10) membrane sweeping (Boulvain 2005);
(11) extra-amniotic prostaglandins (Hutton 2001);
(12) intravenous prostaglandins (Luckas 2000);
(13) oral prostaglandins (French 2001);
(14) mifepristone (Hapangama 2009);
(15) oestrogens with or without amniotomy (Thomas 2001);
(16) corticosteroids (Kavanagh 2006b);
(17) relaxin (Kelly 2001b);
(18) hyaluronidase (Kavanagh 2006a);
(19) castor oil, bath, and/or enema (Kelly 2013);
(20) acupuncture (this review);
(21) breast stimulation (Kavanagh 2005);
(22) sexual intercourse (Kavanagh 2001);
(23) homoeopathic methods (Smith 2003);
(24) nitric oxide donors (Kelly 2011);
(25) buccal or sublingual misoprostol (Muzonzini 2004);
(26) hypnosis (protocol in progress);
(27) other methods for induction of labour.

Types of outcome measures

Primary outcomes

Clinically relevant outcomes for trials of methods of cervical ripening/labour induction have been prespecified by two authors of labour induction reviews (Justus Hofmeyr and Zarko Alfirevic) (Hofmeyr 2009). Differences were settled by discussion.

Five primary outcomes were chosen as being most representative of the clinically important measures of effectiveness and complications. It was agreed that subgroup analyses would be limited to the primary outcomes:
(1) vaginal delivery not achieved within 24 hours;
(2) uterine hyperstimulation with fetal heart rate (FHR) changes;
(3) caesarean section;
(4) serious neonatal morbidity or perinatal death (e.g. seizures, birth asphyxia defined by trialists, neonatal encephalopathy, disability in childhood);
(5) serious maternal morbidity or death (e.g. uterine rupture, admission to intensive care unit, septicaemia).

Perinatal and maternal morbidity and mortality are composite outcomes. This is not an ideal solution because some components are clearly less severe than others. It is possible for one intervention to cause more deaths but less severe morbidity. However, in the context of labour induction at term this is unlikely. All these events will be rare, and a modest change in their incidence will be easier to detect if composite outcomes are presented. The incidence of individual components will be explored as secondary outcomes (see below).

Secondary outcomes

Secondary outcomes relate to measures of effectiveness, complications and satisfaction.

Measures of effectiveness:
(6) cervix unfavourable/unchanged after 12 to 24 hours;
(7) oxytocin augmentation.

Complications:
(8) uterine hyperstimulation without FHR changes;
(9) uterine rupture;
(10) epidural analgesia;
(11) instrumental vaginal delivery;
(12) meconium-stained liquor;
(13) Apgar score less than seven at five minutes;
(14) neonatal intensive care unit admission;
(15) neonatal encephalopathy;
(16) perinatal death;
(17) disability in childhood;
(18) maternal side-effects (all);
(19) maternal nausea;
(20) maternal vomiting;
(21) maternal diarrhoea;
(22) other maternal side-effects;
(23) postpartum haemorrhage (as defined by the trial authors);
(24) serious maternal complications (e.g. intensive care unit admission, septicaemia but excluding uterine rupture);
(25) maternal death.

Measures of satisfaction:
(26) woman not satisfied;
(27) caregiver not satisfied.

Acupuncture specific outcomes:
(28) use of other induction methods;
(29) time from trial intervention to the birth of the baby;
(30) length of labour.

While all the above outcomes were sought, only those with data appear in the analysis tables.

The terminology of uterine hyperstimulation is problematic (Curtis 1987). In the reviews we used the term 'uterine hyperstimulation without FHR changes' to include uterine tachysystole (more than five contractions per 10 minutes for at least 20 minutes) and uterine hypersystole/hypertonus (a contraction lasting at least two minutes) and 'uterine hyperstimulation with FHR changes' to denote uterine hyperstimulation syndrome (tachysystole or hypersystole with fetal heart rate changes such as persistent decelerations, tachycardia or decreased short term variability).

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 (23 November 2012).

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.   

In addition, we searched PubMed (1966 to 23 November 2012), EMBASE (1980 to 23 November 2012), Dissertation Abstracts (1861 to 23 November 2012), CINAHL (1982 to 23 November 2012) and the WHO International Clinical Trials Registry Portal (ICTRP) (23 November 2012). See Appendix 1 for search strategies used.

Searching other resources

We handsearched reference lists of trial reports and reviews.

We did not apply any language restrictions.

The search for the initial version of the review was performed simultaneously for all reviews of methods of inducing labour, as outlined in the generic protocol for these reviews (Hofmeyr 2000).

Data collection and analysis

For methods used in the previous version of this review, see Appendix 2; Appendix 3. These methods followed those described in the generic protocol (Hofmeyr 2009), which was developed in order to provide a standardised methodological approach for conducting a series of reviews examining the various methods of preparing the cervix of the uterus and inducing labour.

For this update we used the following methods when assessing the reports identified by the updated search.

Selection of studies

Two review authors C Smith (CS) and S Grant (SG) independently assessed for inclusion all the potential studies we identified as a result of the search strategy. We resolved any disagreement through discussion or, if required, we consulted a third person. When articles contained insufficient information to make a decision about eligibility, CS attempted to contact authors of the original reports to obtain further details.

Data extraction and management

Following an assessment for inclusion CS, SG independently extracted data using a data extraction form Appendix 4. A third independent person extracted data for a trial undertaken by CS and CC. We resolved discrepancies through discussion or, if required, we consulted a third person. We entered data into Review Manager software (RevMan 2012) 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

Two review authors independently (third for the Smith 2008 trial) assessed the risk of bias for each study using the criteria outlined in the Cochrane Handbook for Systematic Reviews of Interventions ( Higgins 2011 ). We resolved any disagreement by discussion or by involving a third assessor.

(1) Random 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 allocation to interventions prior to assignment and assessed 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.   

(3.1) Blinding of participants and personnel (checking for possible performance bias)

We described for each included study the methods used, if any, to blind study participants and personnel from knowledge of which intervention a participant received. We considered that studies were at low risk of bias if they were blinded, or if we judged that the lack of blinding would be unlikely to affect results. We assessed blinding separately for different outcomes or classes of outcomes.

We assessed the methods as:

  • low, high or unclear risk of bias for participants;

  • low, high or unclear risk of bias for personnel.

(3.2) Blinding of outcome assessment (checking for possible detection bias)

We described for each included study the methods used, if any, to blind outcome assessors from knowledge of which intervention a participant received. We assessed blinding separately for different outcomes or classes of outcomes.

We assessed methods used to blind outcome assessment as:

  • low, high or unclear risk of bias

(4) Incomplete outcome data (checking for possible attrition bias due to the amount, nature and handling of incomplete outcome data)

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 and the numbers included in the analysis at each stage (compared with the total randomised participants), reasons for attrition or exclusion were reported, and whether missing data were balanced across groups or were related to outcomes. Where sufficient information was reported, or was supplied by the trial authors, we planned to re-include missing data in the analyses where possible. Trials with greater than 20% missing data were classified at a high risk of bias.

We assessed methods as:

  • low risk of bias (e.g. no missing outcome data; missing outcome data balanced across groups);

  • high risk of bias (e.g. numbers or reasons for missing data imbalanced across groups; ‘as treated’ analysis done with substantial departure of intervention received from that assigned at randomisation);

  • unclear risk of bias.

(5) Selective reporting (checking for 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 bias (checking for bias due to problems not covered by (1) to (5) above)

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

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

  • 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 were at high risk of bias, according to the criteria given in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). With reference to (1) to (6) above, we assessed the likely magnitude and direction of the bias and whether we considered it was likely to impact on the findings. We explored the impact of 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

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

Unit of analysis issues

Cluster-randomised trials

We did not identify an cluster-randomised trials for inclusion in this update, but plan to include them if identified in future updates. We will include cluster-randomised trials in the analyses along with individually-randomised trials. We will adjust their sample sizes using the methods described in the Cochrane Handbook for Systematic Reviews of Interventions 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 use ICCs from other sources, we will report this and conduct sensitivity analyses to investigate the effect of variation in the ICC. 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 was 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 sensitivity analysis to investigate the effects of the randomisation unit.

Other unit of analysis issues

Trials with multiple arms were included and are described in the Characteristics of included studies. For example, acupuncture might be compared with sham acupuncture and with another arm where no acupuncture was delivered. If there were two acupuncture groups, data from both treatment arms were combined into one group. For studies with a sham control and no treatment control group, the shared intervention was divided evenly between groups as described in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). Where outcomes were repeated measures, analysis of outcomes was undertaken at the end of the intervention.

Dealing with missing data

For included studies, we noted levels of attrition. We aimed to explore the impact of including studies with high levels of missing data in the overall assessment of treatment effect by using sensitivity analysis.

For all outcomes, we 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, and all participants were analysed in the group to which they were allocated, regardless of whether or not they received the allocated intervention. The denominator for each outcome in each trial was the number randomised minus any participants whose outcomes were known to be missing. Studies were excluded from the analysis if there was a high level of missing data (greater than 20%).

Assessment of heterogeneity

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

Assessment of reporting biases

Had there been 10 or more studies in the meta-analysis, we planned to investigate reporting biases (such as publication bias) using funnel plots. We would have assessed funnel plot asymmetry visually. If asymmetry was suggested by a visual assessment, we proposed to perform exploratory analyses to investigate it.

Data synthesis

We carried out statistical analysis using the Review Manager software (RevMan 2012). We used fixed-effect meta-analysis for combining data where it was reasonable to assume that studies were estimating the same underlying treatment effect: i.e. where trials were examining the same intervention, and the trials’ populations and methods were judged sufficiently similar. If there was clinical heterogeneity sufficient to expect that the underlying treatment effects differed between trials, or if substantial statistical heterogeneity was detected, we used random-effects meta-analysis to produce an overall summary if an average treatment effect across trials was considered clinically meaningful. We treated the random-effects summary as the average of the range of possible treatment effects and we discussed the clinical implications of treatment effects differing between trials. If the average treatment effect was not clinically meaningful, we would not have combined trials.

Where we used random-effects analyses, we presented the results as the average treatment effect with 95% confidence intervals, and the estimates of  T² and I².

Subgroup analysis and investigation of heterogeneity

Had we identified substantial heterogeneity, we planned to investigate it using subgroup analyses and sensitivity analyses. We would have considered whether an overall summary was meaningful, and if it was, we would have used random-effects analysis.

Subgroup analyses were not prespecified in the earlier version of the review (Smith 2004).

We planned to carry out the following subgroup analyses:

  1. nulliparity versus multiparity; 

  2. cervix unfavourable, versus favourable versus undefined;

  3. membranes intact or ruptured;

  4. classical/traditional acupuncture versus single point therapy, or auricular acupuncture.

We planned to assess subgroup differences by interaction tests available within RevMan (RevMan 2012) and report the results of subgroup analyses quoting the χ2 statistic and P value, and the interaction test I² value.

Sensitivity analysis

Where subgroup analysis failed to explain the heterogeneity, we planned to analyse the data using a random-effects model. A priori, we planned to perform sensitivity analysis on the results to look at the possible contribution of: (1) differences in methodological quality, with trials of high quality (low risk of bias) compared to all trials; and (2) publication bias by country. If publication bias was present, we planned to undertake a sensitivity analysis excluding trials from countries where there was a greater publication bias.

Results

Description of studies

See: Characteristics of included studies; Characteristics of excluded studies; Characteristics of studies awaiting classification.

Results of the search

The original review included three trials and seven trials were excluded. This updated review includes 14 trials, and excludes eight trials. Three trials previously excluded due to no clinically relevant outcomes are now included (Martinez 2004; Romer 2000; Tremeau 1992). One trial is currently awaiting assessment (Liu 2012).

Included studies

Study design

All studies were parallel design. Nine trials had two groups (Gaudernack 2006; Gaudet 2008; Gribel 2011; Harper 2006; Modlock 2010; Rabl 2001; Romer 2000; Selmer-Olsen 2007; Smith 2008), two trials had three groups (Asher 2009; Tremeau 1992) and one trial had five groups (Mackenzie 2011). Seven studies used sham controls (Asher 2009; Gaudet 2008; Mackenzie 2011; Modlock 2010; Romer 2000; Smith 2008; Tremeau 1992) and eight trials used standard care (Asher 2009; Gaudernack 2006; Gribel 2011; Harper 2006; Mackenzie 2011; Rabl 2001; Selmer-Olsen 2007; Tremeau 1992).

Samples sizes

Sample size of the included studies ranged from 16 (Gaudet 2008) to 553 (Romer 2000).

Study location and sources of women

Two studies were undertaken in Norway (Gaudet 2008; Selmer-Olsen 2007), two in the United States (Asher 2009; Harper 2006), and one each from Austria (Rabl 2001), Australia (Smith 2008), Brazil (Gribel 2011), Canada (Gaudet 2008), China (Long 1994), Denmark (Modlock 2010), France (Tremeau 1992), Germany (Romer 2000) the Phillipines (Martinez 2004) and the United Kingdon (Mackenzie 2011).

Participants

Six studies recruited nulliparous women only (Asher 2009; Gaudet 2008; Harper 2006; Mackenzie 2011; Romer 2000; Selmer-Olsen 2007). Six trials recruited both nulliparous and primiparous women (Gaudernack 2006; Gribel 2011; Modlock 2010; Rabl 2001; Smith 2008; Tremeau 1992). Parity was unclear in two trials (Long 1994; Martinez 2004).

Types of interventions

Eight studies used manual acupuncture only (Asher 2009; Gaudernack 2006; Modlock 2010; Rabl 2001; Romer 2000; Selmer-Olsen 2007; Smith 2008; Tremeau 1992), one trial used electro-acupuncture only (Gribel 2011), and three trials used manual and electro-acupuncture (Gaudernack 2006; Gaudet 2008; Harper 2006). Fixed points were used in nine trials (Asher 2009; Gaudet 2008; Gribel 2011; Harper 2006; Mackenzie 2011; Modlock 2010; Rabl 2001; Romer 2000; Tremeau 1992) and three trials used individualised treatment (Gaudernack 2006; Selmer-Olsen 2007; Smith 2008). There was significant variation in the acupuncture points used but included; Stomach 36 (ST36), Liver 3 (LR3), Conception Vessel 4 (CV4), Three Heater 6 (TH6), Large Intestine 4 (LI4), Gall Bladder 41 (GB41), Kidney 6 (KI6), Spleen 6 (SP6), Heart 7 (HT7), and Lung 7 (LU7), Bladder 31 (UB31), Bladder 32 (UB32), Bladder 60 (UB60) Bladder 67 (UB67), Governing Vessel (GV20).

The number of treatments varied from three trials administering one treatment (Gaudernack 2006; Mackenzie 2011; Rabl 2001), two treatments (Gaudet 2008; Modlock 2010; Selmer-Olsen 2007; Smith 2008) and five providing three of more (Asher 2009; Gribel 2011; Harper 2006; Romer 2000; Tremeau 1992).

Gaudet 2008 used a combination of manual and non active electro-stimulation for the control group.

Few details were reported in two trials (Long 1994; Martinez 2004).

Outcome measures

Few trials reported on the primary outcomes relating to this review. Nine trials reported on caesarean section (Asher 2009; Gaudet 2008; Gribel 2011; Harper 2006; Mackenzie 2011; Modlock 2010; Selmer-Olsen 2007; Smith 2008; Tremeau 1992), although all trials reported on a selection of the secondary outcomes included in this review.

Excluded studies

Eight trials were excluded; see Characteristics of excluded studies.

Four trials were excluded due to insufficient reporting of randomisation (Dorr 1990; Kubista 1974; Li 1996, So 1979) and we were unable to obtain details from authors. One trial was excluded due to an evaluation of acupuncture on pain relief in labour (Bo 2006). One trial reported on women already in labour (Lyngso 2010). Two trials used a form of stimulation not relevant to this review (Aghamohammadi 2011; Dunn 1989).

Risk of bias in included studies

See Figure 1; and Figure 2 for a graphical summary of the 'Risk of bias' assessment by authors of the included studies based on the six domains of bias. One study was at a low risk of bias on all domains (Smith 2008).

Figure 1.

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

Figure 2.

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

Allocation

Twelve trials were rated at a low risk of bias for adequate generation of the randomisation sequence, generation of the randomisation schedule was unclear in two trials (Long 1994; Martinez 2004). The method of concealment was at low risk in 10 trials, with insufficient reporting in four trials (Long 1994; Martinez 2004; Romer 2000; Tremeau 1992).

Blinding

Four studies were at low risk of performance bias (Asher 2009; Gaudet 2008; Romer 2000; Smith 2008). Eight studies were assessed at a high risk of bias primarily because participants were not blind to group allocation in the studies using a standard care control. Detection bias was assessed at a low risk in nine trials (Asher 2009; Gaudernack 2006; Gaudet 2008; Gribel 2011; Mackenzie 2011; Modlock 2010; Romer 2000; Smith 2008; Tremeau 1992), one trial was assessed at high risk and four trials were assessed as unclear.

Incomplete outcome data

Ten trials were assessed at low risk of bias. Two trials were at high risk. In the Rabl trial (Rabl 2001), there were 11 (20%) post-randomisation exclusions and losses to follow-up. There was an imbalance in the post-randomisation exclusions (five in the treatment group and eight in the control group). The trial author was unable to provide outcome data on the 11 women who had been excluded from analyses. Risk was assessed as unclear in two trials.

Selective reporting

The risk of selective reporting was assessed as low in four trials (Mackenzie 2011; Martinez 2004; Modlock 2010; Smith 2008), the risk of bias was unclear in nine trials, and at high risk in one trial (Selmer-Olsen 2007).

Other potential sources of bias

The risk of bias was rated as low in seven trials (Asher 2009; Gaudernack 2006; Gaudet 2008; Gribel 2011; Harper 2006; Mackenzie 2011; Modlock 2010;Smith 2008), and unclear in the other seven trials.

Effects of interventions

This review included 14 trials of 2220 women.

We included 11 trials in the meta-analysis with data reporting on 1689 women. Because data were not available about the post-randomisation exclusions for the Rabl 2001 trial and an intention-to-treat analysis could not be undertaken, the results of this trial could not be incorporated into the meta-analysis. Primary data from the Long 1994 trial could not be obtained and no data are included in the analysis. Martinez 2004 reported on no clinically relevant outcomes.

Primary outcomes

Trials reported on two primary outcomes only: caesarean section and serious neonatal morbidity. No trial reported on vaginal delivery not achieved within 24 hours; uterine hyperstimulation with fetal heart rate (FHR) changes and serious maternal morbidity or death (e.g. uterine rupture, admission to intensive care unit, septicaemia).

1.1) Outcome: caesarean section

Data on caesarean section was reported from 9 trials with 1015 women, (Analysis 1.1).

1.1.1 Sham control

There was no difference in caesarean deliveries between groups (average risk ratio (RR) 0.95, 95% confidence interval (CI) 0.69 to 1.30, six trials, 654 women).

1.1.2 Usual care

There was no difference in caesarean deliveries between groups (average RR 0.69, 95% CI 0.40 to 1.20, six trials, 361 women; Heterogeneity: Tau² = 0.18; I² = 40% ). There was significant heterogeneity indicated by the I2 statistic and we applied a random-effects model.The heterogeneity may be explained by the Asher 2009 and Selmer-Olsen 2007 trials, although it is unclear which aspects of the intervention may explain the heterogeneity.

1.2) Outcome: serious neonatal morbidity
1.2.1 Sham control

There was no difference in neonatal seizures between groups (RR 1.01, 95% CI 0.06 to 16.04, one trial, 364 women), Analysis 1.2.

Serious maternal morbidity or death

There were no serious outcomes or maternal death reported in one trial (Smith 2008).

Secondary outcomes

Secondary outcomes relate to measures of effectiveness, complications and satisfaction. Trials reported on cervix unfavourable/unchanged after 12 to 24 hours; oxytocin augmentation; epidural analgesia; instrumental vaginal delivery; meconium-stained liquor; Apgar score less than seven at five minutes; neonatal intensive care unit admission; perinatal death; postpartum haemorrhage; other maternal side-effects; maternal death; and woman not satisfied. The following acupuncture specific outcomes were included: use of other induction methods; time from trial intervention to the birth of the baby; and length of labour.

No trial reported on the following outcomes; uterine hyperstimulation without FHR changes; uterine rupture; neonatal encephalopathy; disability in childhood; maternal side-effects (all); maternal nausea; maternal vomiting; maternal diarrhoea; serious maternal complications; and caregiver not satisfied.

1.3) Outcome: cervical change within 12 to 24 hours

Data on cervical maturation were available from six trials with data reported in the meta-analysis from two trials, Analysis 1.3. Data were not combined but in both trials there was a greater change in the cervix for the acupuncture groups compared with the control groups, as measured by Bishop score.

1.3.1 Sham control

There was greater cervical change in Bishop score occurring within 24 hours for women receiving acupuncture compared with the sham control, mean difference (MD) 0.40. 95% CI 0.11 to 0.69, one trial, 125 women. Data from the Smith 2008 trial were not included in the meta-analysis and reported an increase in the Bishop score that did not differ between groups (RR 1.08, 95% CI 0.92 to 1.26, one trial 364 women), data not shown.

The Romer 2000 trial did not report on when the cervical change was assessed, however the authors report there was a significant change in the Bishops score (acupuncture 5.9 +/- 1.3 (mean and standard deviation (SD)), non specific acupuncture 4.0, +/- 0.9, and no acupuncture 3.6 +/- 1.0).

1.3.2 Usual care

There was an increase in cervical maturation in the acupuncture group compared with the control (MD 1.30, 95% CI 0.11 to 2.49, one trial, 67 women).

Data from the Harper 2006 trial were not included in the analysis, there was no difference in cervical dilatation on the day of admission (3.3.cm versus 2.7 cm, P = 0.28).

Data from the Tremeau 1992 trial did not include means and SDs but reported a significantly greater progression in the Bishop score for the group receiving acupuncture (2.61 points) compared with the placebo group (0.89), and the usual care group (1.08).

1.4) Outcome: oxytocin augmentation

Data on this outcome were available from seven trials and 1090 women, Analysis 1.4.

1.4.1 Sham control

There was no difference in the use of oxytocin augmentation between acupuncture and a sham control groups (RR 0.97, 95% CI 0.78 to 1.21, four trials, 833 women).

1.4.2 Usual care

There was no difference in the use of oxytocin augmentation between acupuncture and usual care groups (RR 1.08, 95% CI 0.86 to 1.34, three trials, 257 women).

1.5) Outcome: need for epidural

This outcome was reported by eight trials and 922 women, Analysis 1.5.

1.5.1 Sham control

There was no difference in the need for epidural between groups (RR 1.02, 95% CI 0.88 to 1.19, five trials, 571 women).

1.5.2 Usual care

There was no difference in the use of epidurals between groups (RR 0.92, 95% CI 0.77 to 1.11, five trials, 351 women).

1.6) Outcome: instrumental vaginal delivery

Eight trials with 961 women reported on this outcome, Analysis 1.6.

1.6.1 Sham control

There were no differences in the rate of instrumental delivery between groups (average RR 1.19, 95% CI 0.85 to 1.65, five trials, 610 women).

1.6.2 Usual care

There was significant heterogeneity indicated by the I2 statistic and we applied a random-effects model. There was no difference between groups (RR 0.91, 95% CI 0.50 to 1.64, five trials, 351 women; Heterogeneity: Tau² = 0.17; I² = 40%).

1.7 Outcome: meconium-stained liquor

One one trial (364 women) reported on this outcome, Analysis 1.7.

1.7.1 Sham control

There was no difference in meconium-stained liquor between groups (RR 0.81, 95% CI 0.56 to 1.16).

1.8 Outcome: Apgar score less than seven at five minutes

Data on this outcome were reported by six trials (801 women), Analysis 1.8.

1.8.1 Sham control

There was no difference in the Apgar score at five minutes between groups (RR 0.67, 95% CI 0.20 to 2.21, four trials, 559 women).

1.8.2 Usual care

There was no difference in the Apgar score at five minutes between groups (RR 0.35, 95% CI 0.01 to 8.48, three trials, 242 women).

1.9 Outcome: neonatal care admission

Three trials (186 women) reported on this outcome, Analysis 1.9.

1.9.1 Sham control

There was significant heterogeneity indicated by the I2 statistic and we applied a random-effects model. There was no difference between groups (average RR 0.82, 95% CI 0.02 to 37.11, three trials, 141 women; Heterogeneity: Tau² = 5.42; I² = 72%).

1.9.2 Usual care

There was no difference between groups (RR 0.65, 95% CI 0.03 to 14.97, one trial, 45 women).

1.10 Outcome: perinatal death

One one trial (364 women) reported on this outcome, Analysis 1.10.

1.10.1 Sham control

There were no deaths in either group.

1.11 Outcome: perineal tear

One trial (91 women) reported on this outcome, Analysis 1.11.

1.11.1 Usual care

There was no difference in this outcome between groups (RR 1.22, 95% CI 0.95 to 1.56).

1.12 Outcome: maternal infection

Two trials including one three-arm trial (180 women) reported on this outcome, Analysis 1.12.

1.12.1 Sham control

There was no difference between groups (RR 1.29, 95% CI 0.43 to 3.88, one trial, 44 women).

1.12.2 Usual care

There was no difference between groups (RR 1.64, 95% CI 0.43 to 6.32, two trials, 136 women).

1.13 Outcome: fetal infection

One trial (91 women) reported on this outcome, Analysis 1.13.

1.13.1 Usual care

There were no reports of fetal infection between groups.

1.14 Outcome: postpartum bleeding greater than 500 mL

Three trials, 594 women reported on this outcome, Analysis 1.14.

1.14.1 Sham control

There was no difference between groups (RR 1.02, 95% CI 0.67 to 1.54, three trials, 542 women).

1.14.2 Usual care

There was no difference between groups (RR 0.50, 95% CI 0.10 to 2.50, one trial, 52 women).

1.15 Outcome: maternal death

One trial, 364 women reported on this outcome, Analysis 1.15.

1.15.1 Sham control

There were no maternal deaths in either group.

1.16 Outcome: time from trial entry to delivery

Three trials (161 women) reported on this outcome, Analysis 1.16.

1.16.1 Sham control

Two trials reported on this outcome (Asher 2009; Gaudet 2008). Time was reported in hours by Gaudet 2008 and in days by Asher 2009. There was no difference in time to delivery between acupuncture and the sham control (average standardised mean difference (SMD) -0.22, 95% CI -0.99 to 0.55). There was significant heterogeneity indicated by the I2 statistic due to the differing method to record this outcome (Heterogeneity: Tau² = 0.14; Chi² = 1.75, df = 1 (P = 0.19); I² = 43%).

1.16.2 Usual care

This outcome was measured in hours by Harper 2006 and in days by Asher 2009. No difference in time to delivery was found between groups (average SMD 0.25, 95% CI -0.77 to 1.27). There was significant heterogeneity indicated by the I2 statistic due to the differing method to record this outcome (Heterogeneity: Tau² = 0.45; Chi² = 5.98, df = 1 (P = 0.01); I² = 83%).

1.17 Outcome: maternal satisfaction

One trial (67 women) reported on this outcome, Analysis 1.17.

1.17.1. Usual care

There was no difference in maternal satisfaction between groups (RR 1.29, 95% CI 0.99 to 1.67).

1. 18 Outcome: need for induction methods

Seven trials 1236 women reported on this outcome, Analysis 1.18.

1.18.1 Sham control

There was no difference between groups (average RR 1.03, 95% CI 0.91 to 1.16, four trials, 977 women).

1.18.2 Usual care

There was significant heterogeneity indicated by the I2 statistic and we applied a random-effects model (Heterogeneity: Tau² = 0.06; I² = 45%). There was no difference between groups (RR 1.00, 95% CI 0.69 to 1.45, four trials, 259 women).

1.19 Outcome: length of labour

Four trials (761 women) reported on this outcome, Analysis 1.19.

1.19.1 Sham control

There was significant heterogeneity indicated by the I2 statistic and we applied a random-effects model (Heterogeneity: Tau² = 0.08; I² = 69%). There was no difference between groups (SMD -0.18, 95% CI -0.58 to 0.23, three trials, 694 women).

1.19.2 Usual care

The length of labour was shorter in the usual care group compared with acupuncture (MD 0.67, 95% CI 0.18 to 1.17, one trial, 67 women).

Data from other studies

In the Rabl trial (Rabl 2001), 11 (20%) women were post-randomisation exclusions and proceeded to have an elective induction of labour. In the acupuncture group, labour was induced for one woman because of fetal heart abnormalities and two inductions were performed due to prelabour rupture of membranes. In the control group, two women requested an elective induction of labour, three women received an induction of labour because of prelabour rupture of membranes, and in three women labour was induced due to abnormal fetal heart rate patterns. Because data were not available about the post-randomisation exclusions and an intention-to-treat analysis could not be undertaken, no results could be incorporated into this review.

Sensitivity analysis

It was proposed to undertake a sensitivity analysis on the results to look at the possible contribution of: (1) differences in methodological quality, with trials of high quality (low risk of bias) compared to all trials; and (2) publication bias by country. This was not done due to the small number of trials overall. There was one trial of high quality; there were also too few trials within comparisons to make comparisons to examine the influence of publication bias. Where there was heterogeneity, we applied a random-effects model.

Subgroup analysis

We did not undertake subgroup analysis, based on insufficient reporting of trials with the variables of interest by outcome.

Discussion

Summary of main results

Findings from this review are based on comparisons between acupuncture and five sham-controlled trials, and comparisons between acupuncture with five trials using usual care controls. Evidence from 14 trials with data reporting on 2220 women suggest very limited benefit from acupuncture to induce labour. There was insufficient evidence of benefit of acupuncture compared with control for any primary endpoint. Benefit was found from individual trials of both sham and usual care controls.

There was greater cervical change occurring with 24 hours for women receiving acupuncture compared with the sham control, mean difference (MD) 0.40. 95% confidence interval (CI) 0.11 to 0.69, one trial, 125 women. Data from two studies not included in the meta-analysis found conflicting results when comparing acupuncture with a sham control (Romer 2000; Smith 2008). There was an increase in cervical maturation in the acupuncture group compared with the control (MD 1.30, 95% CI 0.11 to 2.49, one trial, 67 women). Two studies (Harper 2006; Tremeau 1992) not included in the meta-analysis also reported greater changes in the cervix for the acupuncture group compared with usual care. One trial found the length of labour was shorter in the usual care group compared with acupuncture (average MD 0.67, 95% CI 0.18 to 1.17, one trial, 67 women). Trials were characterised by heterogenous acupuncture point selection and dosage. Although there have been more trials reported since this review was last updated evaluating the role of acupuncture, there continues to be a relatively small number of trials that have provided relevant health outcomes. This limits the power of the review to detect meaningful differences between groups and analyses, suggesting these limited benefits should be interpreted with caution.

Overall completeness and applicability of evidence

Trials recruited low-risk nulliparous and primiparous women at term. The majority of trials reported that women offered the opportunity to participate in the trial agreed to participate. Smith 2008 however, reported 18% of women approached declined participation due to a lack of interest in acupuncture.

The systematic review documented wide variation in the delivery of acupuncture. This included the mode of stimulation, duration of needling, number of points used, depth of needling and duration of the trial. It is unclear how representative the treatment protocols used in the research are generalisable to acupuncture as it is usually practiced. There was insufficient reporting of the rationale of the acupuncture used in the research setting. Some trials used a fixed approach to the selection of points whilst other used a flexible approach, with selection of acupuncture points based on their clinical presentation. The variation in the duration, frequency and selection of acupuncture points suggests that the acupuncture may not have been therapeutically effective and in some cases may not represent best clinical practice. The variation may also reflect the country context in which acupuncture is practiced.

Quality of the evidence

The 'Risk of bias' tables (Figure 1; Figure 2) demonstrate that acupuncture has not been consistently subjected to consistent rigorous study. Only one trial was assessed at a low risk of bias. Since the publication of this original review the quality of reporting has improved over time. The majority of studies were at a low risk of bias in respect to randomisation. Rates of follow-up were good in the majority of trials with only two trials rated at a high risk of bias. The majority of trials were at a low risk of detection bias. Trials comparing acupuncture with usual care were rated at a high risk of bias due to the inability to blind study participants. The potential for bias however may be low given the use of objective clinical outcomes.

Only one of the sham acupuncture controlled trials used a non -penetrating needle, however these were placed at active acupuncture points and therefore may be associated with some physiological activity. The quality of the evidence is also influenced by small sample sizes, with many studies underpowered to detect changes between groups.

Potential biases in the review process

We attempted to minimise publication bias. Our search was comprehensive and we included studies identified in languages other than English. However, we cannot rule out the possibility that some studies have been missed.

Agreements and disagreements with other studies or reviews

A systematic review examining the effect of acupuncture on induction of labour and cervical maturation found all studies demonstrated labour induction by acupuncture treatment (Lim 2009). The review included 10 studies consisting of randomised controlled trials, non-randomised studies with and without controls, and a matched pair study. The review by Lim et al concluded a definitive role for acupuncture was still to be established and further research was needed. A recent systematic review of methods of induction of labour included our earlier Cochrane review (Smith 2004), and three other randomised controlled trials published since the 2004 Cochrane review (Mozurkewich 2011). The authors concluded that acupuncture for induction of labour is investigational, and no advantages have been demonstrated. Overall, all reviews identify there is insufficient evidence of a benefit from acupuncture.

Authors' conclusions

Implications for practice

There are insufficient data to demonstrate whether acupuncture is more effective than a sham control, or no treatment, or whether there is additional benefit from acupuncture when used in combination with usual care.

Implications for research

Overall, there are still only a small number of studies assessing the role of acupuncture for induction of labour. Further research is required. We suggest further research focuses on gaining a greater understanding of the specific components of acupuncture treatment in relation to working with women who are overdue. Appropriately powered randomised trials are required to examine the effectiveness of acupuncture on the clinical outcomes described in this review but following a greater understanding of the multi-components of acupuncture, or greater reflection of how acupuncture is practiced in a clinical setting.

Acknowledgements

We acknowledge the French to English translation by Peter Smith and the German to English translation by Richmal Oates-Whitehead, with additional translation by Gerald Muench, Julie Brown for data extraction of the Smith 2008 trial, and Xun Li for her assistance with attempted contact with Chinese authors and translations.

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

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. Acupuncture versus control
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Caesarean section9 Risk Ratio (M-H, Random, 95% CI)Subtotals only
1.1 Acupuncture versus sham control6654Risk Ratio (M-H, Random, 95% CI)0.95 [0.69, 1.30]
1.2 Acupuncture versus usual care6361Risk Ratio (M-H, Random, 95% CI)0.69 [0.40, 1.20]
2 Neontal seizure1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
2.1 Acupuncture versus sham1364Risk Ratio (M-H, Fixed, 95% CI)1.01 [0.06, 16.04]
3 Cervical maturity within 24 hours (Bishop score)2 Mean Difference (IV, Fixed, 95% CI)Subtotals only
3.1 Acupuncture versus sham acupuncture1125Mean Difference (IV, Fixed, 95% CI)0.40 [0.11, 0.69]
3.2 Acupuncture versus usual care167Mean Difference (IV, Fixed, 95% CI)1.30 [0.11, 2.49]
4 Oxytocin augmentation7 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
4.1 Acupuncture versus sham4833Risk Ratio (M-H, Fixed, 95% CI)0.97 [0.78, 1.21]
4.2 Acupuncture versus usual care3257Risk Ratio (M-H, Fixed, 95% CI)1.08 [0.86, 1.34]
5 Need for epidural8 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
5.1 Acupuncture versus sham acupuncture5571Risk Ratio (M-H, Fixed, 95% CI)1.02 [0.88, 1.19]
5.2 Acupuncture versus usual care5351Risk Ratio (M-H, Fixed, 95% CI)0.92 [0.77, 1.11]
6 Instrumental vaginal delivery8 Risk Ratio (M-H, Random, 95% CI)Subtotals only
6.1 Acupuncture versus sham5610Risk Ratio (M-H, Random, 95% CI)1.19 [0.85, 1.65]
6.2 Acupuncture versus usual care5351Risk Ratio (M-H, Random, 95% CI)0.91 [0.50, 1.64]
7 Meconium-stained liquor1 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
7.1 Acupuncture versus sham1364Risk Ratio (M-H, Fixed, 95% CI)0.81 [0.56, 1.16]
8 Apgar score less than 76 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
8.1 Acupuncture versus sham4559Risk Ratio (M-H, Fixed, 95% CI)0.67 [0.20, 2.21]
8.2 Acupuncture versus usual care3242Risk Ratio (M-H, Fixed, 95% CI)0.35 [0.01, 8.48]
9 Neonatal care admission3 Risk Ratio (M-H, Random, 95% CI)Subtotals only
9.1 Acupuncture versus sham3141Risk Ratio (M-H, Random, 95% CI)0.82 [0.02, 37.11]
9.2 Acupuncture versus usual care145Risk Ratio (M-H, Random, 95% CI)0.65 [0.03, 14.97]
10 Perinatal death1364Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
10.1 Acupuncture versus sham1364Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
11 Perineal tear191Risk Ratio (M-H, Fixed, 95% CI)1.22 [0.95, 1.56]
11.1 Acupuncture versus usual care191Risk Ratio (M-H, Fixed, 95% CI)1.22 [0.95, 1.56]
12 Maternal infection2 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
12.1 Acupuncture versus usual care2136Risk Ratio (M-H, Fixed, 95% CI)1.64 [0.43, 6.32]
12.2 Acupuncture versus sham144Risk Ratio (M-H, Fixed, 95% CI)1.29 [0.43, 3.88]
13 Fetal infection191Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
13.1 Acupuncture versus usual care191Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
14 Postpartum bleeding > 500 mL3 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
14.1 Acupuncture versus sham3542Risk Ratio (M-H, Fixed, 95% CI)1.02 [0.67, 1.54]
14.2 Acupuncture versus usual care152Risk Ratio (M-H, Fixed, 95% CI)0.5 [0.10, 2.50]
15 Maternal death1364Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
15.1 Acupuncture versus sham1364Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
16 Time from trial entry to birth of baby (days; hours)3 Std. Mean Difference (IV, Random, 95% CI)Subtotals only
16.1 Acupuncture versus sham acupuncture261Std. Mean Difference (IV, Random, 95% CI)-0.22 [-0.99, 0.55]
16.2 Acupuncture versus usual care2100Std. Mean Difference (IV, Random, 95% CI)0.25 [-0.77, 1.27]
17 Maternal satisfaction167Risk Ratio (M-H, Fixed, 95% CI)1.29 [0.99, 1.67]
17.1 Acupuncture versus usual care167Risk Ratio (M-H, Fixed, 95% CI)1.29 [0.99, 1.67]
18 Need for induction methods7 Risk Ratio (M-H, Random, 95% CI)Subtotals only
18.1 Acupuncture versus sham4977Risk Ratio (M-H, Random, 95% CI)1.03 [0.91, 1.16]
18.2 Acupuncture versus usual care4259Risk Ratio (M-H, Random, 95% CI)1.00 [0.69, 1.45]
19 Length of labour4 Std. Mean Difference (IV, Random, 95% CI)Subtotals only
19.1 Acupuncture versus sham3694Std. Mean Difference (IV, Random, 95% CI)-0.18 [-0.58, 0.23]
19.2 Acupuncture versus usual care167Std. Mean Difference (IV, Random, 95% CI)0.67 [0.18, 1.17]
Analysis 1.1.

Comparison 1 Acupuncture versus control, Outcome 1 Caesarean section.

Analysis 1.2.

Comparison 1 Acupuncture versus control, Outcome 2 Neontal seizure.

Analysis 1.3.

Comparison 1 Acupuncture versus control, Outcome 3 Cervical maturity within 24 hours (Bishop score).

Analysis 1.4.

Comparison 1 Acupuncture versus control, Outcome 4 Oxytocin augmentation.

Analysis 1.5.

Comparison 1 Acupuncture versus control, Outcome 5 Need for epidural.

Analysis 1.6.

Comparison 1 Acupuncture versus control, Outcome 6 Instrumental vaginal delivery.

Analysis 1.7.

Comparison 1 Acupuncture versus control, Outcome 7 Meconium-stained liquor.

Analysis 1.8.

Comparison 1 Acupuncture versus control, Outcome 8 Apgar score less than 7.

Analysis 1.9.

Comparison 1 Acupuncture versus control, Outcome 9 Neonatal care admission.

Analysis 1.10.

Comparison 1 Acupuncture versus control, Outcome 10 Perinatal death.

Analysis 1.11.

Comparison 1 Acupuncture versus control, Outcome 11 Perineal tear.

Analysis 1.12.

Comparison 1 Acupuncture versus control, Outcome 12 Maternal infection.

Analysis 1.13.

Comparison 1 Acupuncture versus control, Outcome 13 Fetal infection.

Analysis 1.14.

Comparison 1 Acupuncture versus control, Outcome 14 Postpartum bleeding > 500 mL.

Analysis 1.15.

Comparison 1 Acupuncture versus control, Outcome 15 Maternal death.

Analysis 1.16.

Comparison 1 Acupuncture versus control, Outcome 16 Time from trial entry to birth of baby (days; hours).

Analysis 1.17.

Comparison 1 Acupuncture versus control, Outcome 17 Maternal satisfaction.

Analysis 1.18.

Comparison 1 Acupuncture versus control, Outcome 18 Need for induction methods.

Analysis 1.19.

Comparison 1 Acupuncture versus control, Outcome 19 Length of labour.

Appendices

Appendix 1. Search Strategies

PubMed

1. exp Acupuncture Therapy (10724)

2. exp Medicine, East Asian Traditional (3238)

3. exp Acupuncture/ (15070)

4. (acupuncture or acupressure or acupoint* or electroacupuncture or electro-acupuncture or TENS

5. 1 OR 2 OR 3 OR 4 (32010)

6.  exp induction of labour (1496)

7. exp labour (21925)

8. labo?r

9.  6 OR 7 OR 8

10. 5 AND 9 (101)

11. randomized controlled trial.pt.

12. controlled clinical trial.pt.

13. randomized.ab.

14. placebo.ab.

15. drug therapy.fs.

16. randomly.ab.

17. trial.ab.

18. groups.ab.

19. 11 or 12 or 13 or14 or 15 or 16 or 17 or 18

20.  10 AND 20 (31)

CINAHL Plus search strategy

1.       (MH "Acupuncture+") OR (MH "Acupuncture Points") OR (MH "Acupuncture, Ear") OR (MH "Acupuncturists") OR (MH "Acupuncture Analgesia")

2.       electroacupuncture OR electro-acupuncture

3.       acupressure OR acupoint* OR TENS

4.       #1 OR #2 OR #3 (10,266)

5.       (MH "Labor, Induced+") OR (MH "Labor Stage, First") OR (MH "Labor Stage, Second") OR (MH "Labor Stage, Third") OR (MH "Labor Support")

6.       Caesarean OR Pregnancy OR uterine cervix ripening OR Prostaglandin OR intravaginal drug administration OR Oxytocin OR misoprostol OR labo*r induction OR induction of labo*r

7.       #5 OR #6 (113,359)

8.       (MM "Randomized Controlled Trials") OR (MM "Clinical Trials+") 

9.       randomized controlled trial.pt.  OR controlled clinical trial.pt. OR randomized.ab. OR placebo.ab. OR drug therapy.fs. OR randomly.ab. OR trial.ab. OR groups.ab.

10.   #8 OR #9 (146,052)

11.   #4 AND #7 AND #10 (118)

Embase search strategy

1.       exp acupuncture analgesia/

2.       acupuncture.mp.

3.       exp acupuncture/

4.       exp acupuncture needle/

5.       electroacupuncture OR electro-acupuncture

6.       acupressure OR acupoint* OR TENS

7.       1 OR 2 OR 3 OR 4 OR 5 OR 6 (39862)

8.       cesarean section/ or pregnancy/ or prostaglandin/ or intravaginal drug administration/ or oxytocin/ or uterine cervix ripening/ or prostaglandin E2/ or misoprostol/ or labor induction/ or induction of labour.mp. or prostaglandin derivative/ (732108)

9.       7 AND 8 (1165)

10.   Limited to Human and yr=2012 (59)

11.   Randomization.mp/ or controlled clinical trial.pt. / or double blind procedure/ or randomized controlled trials.mp or (topic)/ or random allocation.mp. / or double blind method.sh. / or meta analysis/ or single-blind method.sh. / or single blind procedure/  or clinical trial.pt.

12.   11 AND 9 (16)

Dissertations and Theses A&I (ProQuest)

Acupuncture AND [labour OR labor] in Title, Subject, Abstract

WHO International Clinical Trials Registry Platform (ICTRP)

Acupuncture AND (labour OR labor)

Appendix 2. Methods used to assess trials included in previous versions of this review

Prior to 2001, data extraction was conducted centrally using the methods outlined below, for all reviews on interventions for labour induction.

From 2001, the data extraction was no longer conducted centrally. This meant that the data extraction was carried out by the reviewers of the primary reviews if new trials were found when the search strategy was rerun, and the reviews updated.

The following methods were used to assess Gaudernack 2006; Harper 2006; Rabl 2001.

A strategy was developed to deal with the large volume and complexity of trial data relating to labour induction. Many methods have been studied, examining the effects of these methods when induction of labour was undertaken in a variety of clinical groups e.g. restricted to primiparous women or those with ruptured membranes. Most trials are intervention-driven, comparing two or more methods in various categories of women. Clinicians and parents need the data arranged according to the clinical characteristics of the women undergoing induction of labour, to be able to choose which method is best for a particular clinical scenario. To extract these data from several hundred trial reports in a single step would be very difficult. We therefore developed a two-stage method of data extraction. The initial data extraction was done in a series of primary reviews arranged by methods of induction of labour, following a standardised methodology. The intention was then to extract them from the primary reviews into a series of secondary reviews, arranged by the clinical characteristics of the women undergoing induction of labour.

To avoid duplication of data in the primary reviews, the labour induction methods were listed in a specific order, from one to 25. Each primary review included comparisons between one of the methods (from two to 25) with only those methods above it on the list. Thus, the review of intravenous oxytocin (4) included only comparisons with intracervical prostaglandins (3), vaginal prostaglandins (2) or placebo (1). Methods identified in the future will be added to the end of the list. The current list is as follows:

(1) placebo/no treatment;
(2) vaginal prostaglandins (Kelly 2003);
(3) intracervical prostaglandins (Boulvain 2008);
(4) intravenous oxytocin (Kelly 2001a);
(5) amniotomy (Bricker 2000);
(6) intravenous oxytocin with amniotomy (Howarth 2001);
(7) vaginal misoprostol (Hofmeyr 2003);
(8) oral misoprostol (Alfirevic 2006);
(9) mechanical methods including extra-amniotic Foley catheter (Boulvain 2001);
(10) membrane sweeping (Boulvain 2005);
(11) extra-amniotic prostaglandins (Hutton 2001);
(12) intravenous prostaglandins (Luckas 2000);
(13) oral prostaglandins (French 2001);
(14) mifepristone (Neilson 2000);
(15) oestrogens with or without amniotomy (Thomas 2001);
(16) corticosteroids (Kavanagh 2006b);
(17) relaxin (Kelly 2001b);
(18) hyaluronidase (Kavanagh 2006a);
(19) castor oil, bath, and/or enema (Kelly 2001);
(20) acupuncture (Smith 2004);
(21) breast stimulation (Kavanagh 2005);
(22) sexual intercourse (Kavanagh 2001);
(23) homoeopathic methods (Smith 2003);
(24) nitric oxide (Kelly 2011 );
(25) buccal or sublingual misoprostol (Muzonzini 2004);
(26) other methods for induction of labour.

The primary reviews were analysed by the following subgroups:
(1) previous caesarean section or not;
(2) nulliparity or multiparity;
(3) membranes intact or ruptured;
(4) cervix favourable, unfavourable or undefined.

The secondary reviews would have included all methods of labour induction for each of the categories of women for which subgroup analysis has been done in the primary reviews. There would have thus been six secondary reviews, of methods of labour induction in the following groups of women:

(1) nulliparous, intact membranes (unfavourable cervix, favourable cervix, cervix not defined);
(2) nulliparous, ruptured membranes (unfavourable cervix, favourable cervix, cervix not defined);
(3) multiparous, intact membranes (unfavourable cervix, favourable cervix, cervix not defined);
(4) multiparous, ruptured membranes (unfavourable cervix, favourable cervix, cervix not defined);
(5) previous caesarean section, intact membranes (unfavourable cervix, favourable cervix, cervix not defined);
(6) previous caesarean section, ruptured membranes (unfavourable cervix, favourable cervix, cervix not defined).

Each time a primary review was updated with new data, those secondary reviews which included data which have changed, would also have been updated.

The trials included in the primary reviews were extracted from an initial set of trials covering all interventions used in induction of labour (see above for details of search strategy). The data extraction process was conducted centrally. This was co-ordinated from the Clinical Effectiveness Support Unit (CESU) at the Royal College of Obstetricians and Gynaecologists, UK, in co-operation with the Pregnancy and Childbirth Group of the Cochrane Collaboration. This process allowed the data extraction process to be standardised across all the reviews.

The trials were initially reviewed on eligibility criteria, using a standardised form and the basic selection criteria specified above. Following this, data were extracted to a standardised data extraction form which was piloted for consistency and completeness. The pilot process involved the researchers at the CESU and previous reviewers in the area of induction of labour.

Information was extracted regarding the methodological quality of trials on a number of levels. This process was completed without consideration of trial results. Assessment of selection bias examined the process involved in the generation of the random sequence and the method of allocation concealment separately. These were then judged as adequate or inadequate using the criteria described in Appendix 3 for the purpose of the reviews.

Performance bias was examined with regards to whom was blinded in the trials i.e. patient, caregiver, outcome assessor or analyst. In many trials the caregiver, assessor and analyst were the same party. Details of the feasibility and appropriateness of blinding at all levels was sought.

Predefined subgroup analyses were: previous caesarean section or not; nulliparity or multiparity; membranes intact or ruptured, and cervix unfavourable, favourable or undefined. Only those outcomes with data appear in the analysis tables.

Individual outcome data were included in the analysis if they met the pre-stated criteria in 'Types of outcome measures'. Included trial data were processed as described in the Cochrane Reviewers' Handbook (Clarke 2002). Data extracted from the trials were analysed on an intention-to-treat basis (when this was not done in the original report, re-analysis was performed if possible). Where data were missing, clarification was sought from the original authors. If the attrition was such that it might significantly affect the results, these data were excluded from the analysis. This decision rested with the reviewers of primary reviews and is clearly documented. If missing data become available, they will be included in the analyses.

Data were extracted from all eligible trials to examine how issues of quality influence effect size in a sensitivity analysis. In trials where reporting was poor, methodological issues were reported as unclear or clarification sought.

Once the data had been extracted, they were distributed to individual reviewers for entry onto the Review Manager computer software (RevMan 2000), checked for accuracy, and analysed as above using the RevMan software. For dichotomous data, relative risks and 95% confidence intervals were calculated, and in the absence of heterogeneity, results were pooled using a fixed-effect model.

The predefined criteria for sensitivity analysis included all aspects of quality assessment as mentioned above, including aspects of selection, performance and attrition bias.

Primary analysis was limited to the prespecified outcomes and subgroup analyses. In the event of differences in unspecified outcomes or subgroups being found, these were analysed post hoc, but clearly identified as such to avoid drawing unjustified conclusions.

In 2012 the methods and software for carrying out reviews were updated, as a result of which new reviews and updates, where appropriate, used these new methods (Higgins 2011; RevMan 2012), which are described in the Methods section of all the individual new and updated reviews.

Appendix 3. Methodological quality of trials

Methodological itemAdequateInadequate
Generation of random sequenceComputer generated sequence, random number tables, lot drawing, coin tossing, shuffling cards, throwing dice.Case number, date of birth, date of admission, alternation.
Concealment of allocationCentral randomisation, coded drug boxes, sequentially sealed opaque envelopes.Open allocation sequence, any procedure based on inadequate generation.

Appendix 4. Data extraction form

The Cochrane Pregnancy and Childbirth Group  

Review title: Acupuncture for induction of labour

 

Review ID:

 

Study ID:

 

Reference ID:

 

Person extracting data:

 

Date of date extraction:

 

Year of study publication:

 

Title:

 

Author:

 

Reference:

 

 

Study design

 

Type of study design (cluster RCT; block randomisation; stratified randomisation; multi-arm; factorial etc):

 

Unit of randomisation:

 

 

Participants and setting

 

Describe setting:

Inclusion criteria:

 

Intervention

 

Comparison

Outcomes:

Study methods

Risk of bias

Adequate sequence generation

Was the allocation sequence adequately generated?

                                                                                               Yes / Unclear / No

 

Allocation concealment

Was allocation concealment adequate?

                                                                                               Yes / Unclear / No

Describe:   

Blinding

Was knowledge of the allocated intervention adequately prevented during the study?

Participant:                                                                   Yes / Unclear / No

Clinician:                                                                       Yes / Unclear / No

Outcome assessor :                                                                 Yes / Unclear / No

 

Describe:

                                                               

Incomplete outcome  data addressed

Were complete outcome data adequately addressed?

 

                                                                                                 Yes / Unclear / No

 

Describe any loss of participants to follow-up at each data collection point:                                                             

 

Describe any exclusion of participants after randomisation:

Was the analysis intention to treat? If not has the data been able to be re-included?

                                                     

Free of selective reporting bias

Are reports of study free of suggestions of selective reporting bias?

 

                                                                                                   Yes / Unclear / No

Describe:   

Free of other bias

Was the study apparently free of other problems that could put it at high risk of bias?

 

                                                                                                   Yes / Unclear / No

If the study was stopped early, explain the reasons:

 

Describe any baseline in balance:

 

Describe any differential diagnosis:

 

 

Additional information requested

Outcomes for main analysis

 

 

Outcome Measures (Dichotomous)

    Total number of participants in study = 101

 

Intervention group

total no. in study =

Comparison group

Total no. in study =

eventsTotaleventstotal
  Primary:    
1vaginal delivery not achieved within 24 hours;    
2uterine hyperstimulation with fetal heart rate (FHR) changes;    

3

 

caesarean section;    
4serious neonatal morbidity or perinatal death (e.g. seizures, birth asphyxia defined by trialists, neonatal encephalopathy, disability in childhood);    
5serious maternal morbidity or death (e.g. uterine rupture, admission to intensive care unit, septicaemia)    
 Secondary:    
6cervix unfavourable/unchanged after 12 to 24 hours;    
7oxytocin augmentation.    
8uterine hyperstimulation without FHR changes;    
9uterine rupture    
10epidural analgesia;    
11instrumental vaginal delivery;    
12meconium-stained liquor;    
13Apgar score less than seven at five minutes;    
14neonatal intensive care unit admission;    
15neonatal encephalopathy;    
16perinatal death;    
17disability in childhood;    
18maternal side-effects (all);    
19maternal nausea;    
20maternal vomiting    
21maternal diarrhoea;    
22other maternal side-effects;    
23postpartum haemorrhage (as defined by the trial authors);    
24serious maternal complications (e.g. intensive care unit admission, septicaemia but excluding uterine rupture);    
25maternal death    

 

 

 

Outcome Measures (Continuous)  

      Total number of participants in study =

 

Intervention group

Total no. in study =

Control group

Total no. in study =

totalmeanSDtotalmeanSD
  Secondary      
1woman not satisfied;      
2care giver not satisfied      
3use of other induction methods;      
4time from trial intervention to the birth of the baby;      
5length of labour      

 

Outcomes for subgroup analyses

previous caesarean section or not;

nulliparity or multiparity;

membranes intact or ruptured, and cervix unfavourable, favourable or undefined. Other subgroup analyses will examine the effects of different styles of acupuncture (for example classical/traditional acupuncture versus single point therapy, or auricular acupuncture), as well as the type of control group.

 

 

Outcome Measures (Dichotomous)

    Total number of participants in study =

 

Intervention group

Total no. in study =

Control group

Total no. in study =

eventsTotaleventstotal
 

 Primary:

 

    
1 

 

 

 

 

 

 

  
2     

 

 

 

Secondary:

    
3     
4     
5     

 

 

 

Outcome Measures (Continuous)  

     Total number of participants in study =

 

Intervention group

Total no. in study =

Control group

Total no. in study =

totalmeanSDtotalmean SD
 

 Primary:

 

 

 

Median

 

IQR

   
1       
2       

 

 

 

Secondary:

      
3       
4       
5       

                                                     

General conclusions

 

 

Very brief summary of study authors main findings/conclusions:

 

 

Exclusion after data extraction

 

 

Reasons for exclusion: (study design? participants? interventions/ outcomes? attrition? bias?)

 

 

 

 

 

What's new

Last assessed as up-to-date: 14 December 2012.

DateEventDescription
7 February 2013New citation required and conclusions have changedEleven trials have been added since the last update. Conclusions have changed for one outcome: need for induction methods. There is now no difference in the use of additional induction methods between acupuncture and standard care groups.
23 November 2012New search has been performedSearch updated and 18 trial reports identified.

History

Protocol first published: Issue 2, 2000
Review first published: Issue 1, 2001

DateEventDescription
23 May 2012AmendedSearch updated. Fifteen reports added to Studies awaiting classification.
10 November 2008AmendedContact details updated.
13 August 2008AmendedCorrected typing mistake in the Plain language summary.
8 February 2008New search has been performedSearch updated. We identified nine new trial reports for eight trials, two of which have been included (Gaudernack 2006; Harper 2006a), three excluded (Bo 2006; Martinez 2004a; So 1979), one is awaiting assessment (Coeytaux 2007) and two are ongoing (Lorentzen 2006; Modlock 2006).
8 February 2008AmendedConverted to new review format.
31 October 2003New search has been performedSearch updated. We identified one new trial that met the inclusion criteria (Rabl 2001) and two new trials which we excluded (Dorr 1990;Romer 2000a ).

Contributions of authors

Caroline Smith conceptualised and took the lead in writing the protocol and the original review. She performed initial searches of databases for trials, was involved in selecting trials for inclusion, performed data extraction and quality assessment of the included trials, was responsible for statistical analysis and interpretation of the data, and wrote the first draft of this update.

Caroline Crowther was involved with selecting trials for inclusion, performed data extraction and quality assessment of the included trials, interpretation of the data and commented on drafts of the protocol and the original review and drafts of this update.

Suzanne Grant was involved with selecting trials for inclusion, performed data extraction and quality assessment of the included trials, interpretation of the data and commented on drafts of this updated review.

Declarations of interest

Caroline Smith and Caroline Crowther are both authors on one of the included trials (Smith 2008), and so a third independent person assessed and extracted data for this trial.

Sources of support

Internal sources

  • University of Western Sydney, Australia.

  • University of Adelaide, Australia.

External sources

  • No sources of support supplied

Differences between protocol and review

Methods updated to current Cochrane Pregnancy and Childbirth Group standard text.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Asher 2009

Methods89 women were randomised to 3 groups true acupuncture (TCM) (n = 30), sham (n = 29), control (n = 30). Sample size was determined by 30 participants per group to provide 80% power to detect a 3-day difference between groups.
ParticipantsThe trial took place at a medical centre in North Carolina, USA. Women included were nulliparous, between 38 and 41 weeks of gestation, able to communicate in English, and at least 18 years old. Exclusion criteria included uncertain dating, transportation difficulties, breech presentation, or a previous inability to tolerate acupuncture.
Interventions

The true acupuncture group received needles bilaterally at LI4, SP6, UB32, and UB54 alongside routine prenatal care. Needles were manually stimulated until de qi was attained and retained for 30 minutes. Treatments were administered for up to a maximum of 5 treatments over a 2-week period. Acupuncture was performed by 2 licensed acupuncturists. Needles were Seirin J-type (0.16 mm x 30 mm for hand and leg points, 0.24 mm x 40 mm for back points).

The sham acupuncture group received invasive shallow needle insertion at non-acupuncture points on the hands, legs, and lower back, bilaterally, alongside routine prenatal care. Needles were retained for 30 minutes.

Patients enrolled in the true acupuncture or sham acupuncture group received treatment within 30 minutes of enrolment.

The control group received routine prenatal care only.

Outcomes

The primary outcome measure was time from enrolment (first acupuncture treatment) to time of delivery.

Secondary outcomes were rates of inpatient induction for post-term pregnancy, spontaneous rupture of membranes, caesarean section, assisted delivery, chorioamnionitis, endometritis, postpartum haemorrhage or uterine atony, maternal length of stay, intrapartum fetal distress, and neonatal outcomes (e.g. Apgar scores, post-delivery oxygen requirement).

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer-generated numbers using Stata (v8, Statacorp, College Station, TX) in equal blocks of 2 and 4.
Allocation concealment (selection bias)Low riskConsecutively numbered, sealed, manila envelopes containing the study arm assignment were opened by the principal investigator for each participant after all entry criteria were confirmed.
Blinding of participants and personnel (performance bias)
All outcomes
Low riskPrenatal care providers and participants were masked to the treatment arm assignment if they were receiving acupuncture (TCM or sham acupuncture) but not if they were in the usual care group.
Blinding of outcome assessment (detection bias)
All outcomes
Low riskAll charts were reviewed by an investigator who was blinded to treatment arm assignment throughout the data abstraction process.
Incomplete outcome data (attrition bias)
All outcomes
Low risk1 woman in the sham group refused any treatments, 1 woman in the routine care group received acupuncture outside of the study.  All participants were analysed.
Selective reporting (reporting bias)Unclear riskNo study protocol available.
Other biasLow riskNo imbalance at randomisation.

Gaudernack 2006

MethodsSingle-blind, randomised controlled trial of acupuncture versus standard care.
Participants100 Norwegian women were randomised, 48 to the acupuncture group and 52 to the control group. The trial was undertaken in Norway, and included women with a singleton pregnancy, with spontaneous rupture of membranes, cephalic presentation and at term. Women were excluded if contractions were occurring at least every 10 minutes, lasting more than 30 seconds.
Interventions

The acupuncture intervention included stimulation of acupuncture points LR3, ST36, CV4; in addition, acupuncture points were administered according to the TCM diagnosis. Total of 9 points used. Needles were retained for 20 minutes. Following treatment women left the hospital to await onset of labour.

Women in the control group received conventional medical treatment including prostaglandins and or oxytocin.

OutcomesOxytocin augmentation, use of other induction agents, time from trial intervention to the birth of the baby, epidural analgesia, instrumental vaginal delivery, maternal side-effects (infection), bleeding, tears, birthweight and Apgar score < 7 at 5 minutes.
NotesThere was no power calculation.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskThe trial generated a computer-generated, randomisation schedule.
Allocation concealment (selection bias)Low riskRandomisation was concealed in sealed envelopes. Allocation was undertaken by the midwife.
Blinding of participants and personnel (performance bias)
All outcomes
High riskIt was not feasible for women and therapist to be blind to group allocation.
Blinding of outcome assessment (detection bias)
All outcomes
Low riskIt was unclear if the outcome assessor and analyst were blind to group allocation.
Incomplete outcome data (attrition bias)
All outcomes
Low risk5 women excluded from analysis in the acupuncture group, 1 due to wrong treatment allocation and 4 had caesarean delivery. 4 women were excluded from the control due to caesarean delivery.
Selective reporting (reporting bias)Unclear riskNo study protocol available.
Other biasUnclear riskIntention-to-treat not reported. Baseline characteristics not reported.

Gaudet 2008

Methods16 participants were randomised to receive either true acupuncture or sham acupuncture.
ParticipantsThe study took place in an obstetrics clinics in Canada. Women who were 39 + 0 and 40 + 3 weeks' gestation were approached. Inclusion criteria included nulliparity, an uncomplicated singleton gestation, provision of informed consent, a Bishop’s score of < 7 prior to randomisation, and reassuring fetal status. All interested patients underwent a digital cervical examination by the research nurse prior to randomisation in order to determine the Bishop’s score. If the Bishop’s score was < 7, patients underwent an ultrasound to complete a biophysical profile and an amniotic fluid index. Patients were randomised if they had a biophysical profile score of 8/8 and a normal amniotic fluid index.
Interventions

2 appointments for acupuncture sessions were arranged, the first within 2 to 3 days, and the second within 1 week, with an accredited physiotherapist acupuncturist.

The true acupuncture group received electro-acupuncture at SP6, ST43 and UB60 with manual stimulation of LI4. Patients received electro-stimulation on 4 points at 1-2 Hz for 30-45 minutes.

The sham acupuncture group received acupuncture at sites adjacent to the acupuncture sites. These were not known to have an effect on initiation of labour or to be located on actual acupuncture meridians. The sites used were SP6+, LI4+, ST43+, BL60+ and GB36+. The locations were SP6+: above the anterior ankle joint line slightly lateral to the border of the tibia, LI4+: in the centre of the anatomical snuff box (located between the 1st and 2nd metacarpal bones), ST43+: at the joint line of the ankle superior to the web space of the 3rd and 4th metatarsal bones, BL60+: inferior and posterior to the fibula head, and GB36+: also inferior and posterior to the fibula head. Sham sites were stimulated in the same order as the true acupuncture sites. Electro-stimulation was applied as in the treatment group.

Both groups were instructed in acupressure and encourage to apply acupressure every few hours for approximately 3 to 5 minutes, at the most important sites (LI4 and SP6 or corresponding sham sites).

OutcomesThe primary outcome was time from first acupuncture treatment to delivery. Secondary outcomes included the need for standard methods for induction of labour, duration of active labour, the need for standard pain relief, and the incidence of non-reassuring fetal heart rate in labour.
NotesIntention-to-treat analysis conducted.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomisation was performed using a table of random numbers.
Allocation concealment (selection bias)Low riskSequentially numbered sealed opaque numbers.
Blinding of participants and personnel (performance bias)
All outcomes
Low riskParticipants blinded using sham acupuncture, clinicians administering the treatment not able to be blinded but were blinded to all obstetrical parameters. The obstetric care providers were blinded.
Blinding of outcome assessment (detection bias)
All outcomes
Low riskThe trial researchers were blinded.
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo participants lost.
Selective reporting (reporting bias)Unclear riskNo study protocol available.
Other biasLow riskNo difference in baseline characteristics.

Gribel 2011

Methods72 multiparous or nulliparous pregnant women were randomised to receive either acupuncture or misoprostol.
ParticipantsThe study took place in a maternity hospital in Brazil. Women were included if they had a Bishop score < 7, single cephalic presentation with gestational age confirmed by ultrasound, with normal ranges for reactive cardiotocography, amniotic fluid volume, blood pressure (< 110 and < 160 mmHg), controlled diabetes, and estimated fetal weight. Women with contraindications for vaginal delivery.
Interventions

The acupuncture group received acupuncture at :LI4, ST36, LR3, SP6, UB23 and UB32. Points were bilaterally electro-stimulated using two distinct frequencies (5 and 50 Hz) that alternated every 7 pulses for 30 minutes. Electro-acupuncture was performed using a (DIAN series # NS AH1405) pulse generator. The electric current intensity was slowly increased until it could be felt by each patient, although without discomfort (30 min) in the ventral (in lied down position with 30_ dorsal elevation) and in the dorsal points (in the sit down position). Stimulation was performed every 7 hours in 1 to up to 3 sessions in a 24 hour period of hospitalisation to all 6 points. Needles were 0.25 x 30. Only 1 physician, with 10 years experience in providing acupuncture to pregnant women, provided the acupuncture.

The control group received misoprostol (25 mg intravaginally; every 6 hours; up to 4 tablets) within 24 hours.

Outcomes

Primary outcome: successful induction of vaginal delivery within 24 hours.

Secondary outcomes: labour induction; induction and labour duration, caesarian section rate; and initial and final Bishop score (defined as the scores at the end of the protocol, or at the beginning of labour). Labour was defined as 2 to 3 30-40 duration, contractions every 10 minutes for more than 60 minutes, with a 2 or 3 cm dilation of cervix in multiparous or nulliparous women, patient satisfaction.

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer-generated, Internet-based block randomisation.
Allocation concealment (selection bias)Low riskSealed envelopes were used.
Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants and clinicians were not blinded.
Blinding of outcome assessment (detection bias)
All outcomes
Low riskOutcome assessors were blinded (information attained through email correspondence with the author).
Incomplete outcome data (attrition bias)
All outcomes
Low risk3 patients from the misoprostol group were excluded, 2 refused to participate and 1 used a dosage different to the study protocol. 2 patients were excluded from the acupuncture group as they used misoprostol during their hospital stay. These participants excluded after randomisation were not included in the final analysis.
Selective reporting (reporting bias)Unclear riskNo study protocol available.
Other biasLow riskNo imbalance at randomisation.

Harper 2006

MethodsSingle-blind, randomised controlled trial of acupuncture versus standard care. Group assignment was made by the principal investigator after entry criteria were confirmed.
Participants56 women were randomised to the trial. The trial was undertaken in an outpatient clinic at the University of North Carolina, USA. Women were included if they were primiparous, with a Bishops score < 7, between 39 and 4 days to 41 weeks, with a cephalic presentation. Women were excluded if they had a contraindication to vaginal delivery, uncertain dating or an inability to tolerate acupuncture.
Interventions

The intervention group involved acupuncture administered for 3 out of 4 consecutive days from the first day of enrolment. A Licensed TCM acupuncturist administered the acupuncture. Acupuncture was administered bilaterally to LI4, SP6, UB31 and 32. Electro-acupuncture was administered to the sacrum UB31 and 32 points with current at 2Hz during the 30-minute treatment. needles retained for 30 minutes.

The control group received routine care (not specified).

OutcomesCaesarean section, cervical change, time from administration of acupuncture to delivery, mode of delivery spontaneous onset of labour, neonatal complications.
NotesPre trial power analysis undertaken.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskThe trial generated a computer-generated randomisation schedule.
Allocation concealment (selection bias)Low riskRandomisation was concealed in sealed envelopes.
Blinding of participants and personnel (performance bias)
All outcomes
High riskIt was not feasible for women and therapist to be blind to group allocation.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskIt was unclear if the outcome assessor and analyst were blind to group allocation.
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo losses to follow-up.
Selective reporting (reporting bias)Unclear riskNo study protocol available.
Other biasLow riskNo imbalance at randomisation.

Long 1994

MethodsThis trial compared pregnant women receiving auricular acupressure and rivanol with a control group who received rivanol only.
Participants400 women were recruited from China. No other details provided.
InterventionsAuricular acupuncture was applied to points: Inner genitals, Sympathetic, Shenmen, Liver, Yuanzhong and Adrenal gland, using a white mustard seed or a pill with adhesive plaster. The points were pressed by the woman until the points felt warm, distention and a numb sensation was generated. The control group received 1% rivanol.
OutcomesTime to induce labour, amount of bleeding, length of labour, and mental state of woman.
NotesContact was attempted with the author, advised the author had retired, and no contact could be established.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskWomen were equally divided into the 2 groups, no further details provide.
Allocation concealment (selection bias)Unclear riskNot stated.
Blinding of participants and personnel (performance bias)
All outcomes
High riskWomen would not be blind to their group allocation.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot stated.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNot stated.
Selective reporting (reporting bias)Unclear riskNot stated.
Other biasUnclear riskNot stated.

Mackenzie 2011

MethodsThis was a double-blind manual, electro- and sham acupuncture study comparing acupuncture with a control group for analgesia for labour induction.
ParticipantsNulliparous women from the United Kingdon with a singleton pregnancy and fetal cephalic presentation with intact membranes undergoing labour induction using vaginal prostaglandins and low amniotomy were eligible for the study. Women with a previous experience of acupuncture were excluded.
Interventions

105 women were randomised to receive manual acupuncture, electro-acupuncture or sham acupuncture or sham electro-acupuncture or no treatment. In the manual acupuncture and electro-acupuncture group the following points were needled: LI4, SP6, UB60, UB67. Serin needles (0.20 x 30-0.30 x 50 mm) were inserted to a depth of 15-20 mm with de qi sensation attained. In the manual group needles were stimulated intermittently and irregularly by hand for 30 minutes. In the electro-acupuncture group, points were stimulated by an electrical stimulator with 2-Hz pulses of 0.5 millisecond duration for 30 minutes, sufficient to cause non-painful muscle contractions. In the sham acupuncture group, needles were inserted at sites adjacent to the specific acupuncture points to a depth of 1-1.5 mm only and insufficient to provoke an unusual sensation. The sham electro-acupuncture group were connected to a electrical stimulator but the current was not activated.

Intrapartum care was provided by the routine delivery suite staff. Subsequent pain management including aromatherapy, TENS and parenteral opioids, and regional blockade was provided when requested or recommended by the attending midwife or obstetrician.

OutcomesThe primary outcome was the rate of intrapartum epidural analgesia requirement. Other outcomes included caesarean section, instrumental deliver, length of labour, Apgar scores.
NotesA power calculation was done based on the reduction in epidural rates.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandom numbers were generated using a computer program (RALLOC, Stata Corporation, Singleton, TX, USA) and randomisation was stratified by the acupuncturist.
Allocation concealment (selection bias)Low riskAllocations were concealed in numbered sealed opaque envelopes opened only after consent and immediately before treatment.
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Study allocation was concealed from all except the acupuncturist, who was not involved with intrapartum management (double blind).

Women randomised to the ‘no-treatment’ control group were aware of their treatment group (single blind).

Great care was taken to conceal treatment allocation from those providing intrapartum care

Blinding of outcome assessment (detection bias)
All outcomes
Low risk

Attempts to ensure outcome assessment was blind to group allocation.

The randomisation code was only revealed after completion of the clinical study.

                                                         

Incomplete outcome data (attrition bias)
All outcomes
Low riskAll participant data were included in the analysis. 2 protocol violations, 1 woman randomised to control group received acupuncture, and a second woman was randomised to electro-acupuncture but withdrew from the study before the acupuncture was administered.
Selective reporting (reporting bias)Low riskAll outcomes reported as per outcomes stated on trial registry.
Other biasLow riskNo imbalance at randomisation.

Martinez 2004

MethodsAcupuncture versus no treatment to examine the effect on uterine contractions.
Participants

The Obstetrics Out-patient Department of the university hospital in the Phillipines.

50 pregnant women who were term, singleton, not in labour, and with uncomplicated course of pregnancy were included in the study. Exclusion criteria: women who were in the active phase of labour, who had previous caesarean section, premature rupture of membranes, concomitant medical illness, or allergy to metals, such as chromium or zinc.

InterventionsSpleen 6 (point Sanyinjiao) is on the lower leg approximately 3 inches proximal to the centre of the medial malleolus was stimulated bilaterally. SP6 was pierced on both sides of the lower extremities.  Two minutes were allotted for each patient for the insertion of the acupuncture needle. The control group received no intervention.
OutcomesThe frequency, intensity, duration, and interval of uterine contractions were measured for 20 minutes. No outcomes relevant to the review were reported.
NotesThe trial did not report on any outcomes relevant to this review.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot reported.
Allocation concealment (selection bias)Unclear riskNot reported.
Blinding of participants and personnel (performance bias)
All outcomes
High riskPartcipant and clinician not blinded.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot reported.
Incomplete outcome data (attrition bias)
All outcomes
Low riskComplete data, no losses.
Selective reporting (reporting bias)Low riskSingle outcome collected relating to uterine contractions.
Other biasUnclear riskNo imbalance at randomisation.

Modlock 2010

MethodsAcupuncture versus sham non invasive acupuncture.
Participants

The study was undertaken in Aarhus University Hospital, and Herning Hospital, Denmark, 1/2/2007-31/5/2008.

125 healthy pregnant women at gestational week 41+6 were recruited to the study.

 

Exclusion criteria: woman did not speak or understand the Danish language; multiple pregnancy; PROM or contractions at 4- to 5-minute intervals and increasing in intensity; previous caesarean section; diseases of the mother or unborn child (diabetes, pre-eclampsia, diseases of the heart, liver or kidneys, HIV/AIDS, malformation of the pelvis, psychological disorders, intrauterine growth restriction, hydrocephalus, suspected macrosomia, fetal malposition, antepartum stillbirth, treatment with anticoagulants, skin infections, allergy to metal, or major complications at previous delivery such as low Apgar score.

Interventions

Acupuncture was administered to points BL67, LI4, SP6, GV20.

The control used the park sham needle (non invasive) at real acupuncture points BL67, LI4, SP6, GV20.

The Park supporting device was used to hold the needle in place for both groups.

The intervention was delivered by trained midwives. The intervention was administered over 30 minutes, needles were stimulated every 10 minutes. Treatment commenced at 8.00am, and if the primary endpoint had not occurred by this time the treatment was repeated at 2.30pm

Outcomes

The primary outcome was achieved if the participant had undergone delivery or was in active labour, defined as rupture of fetal membranes and/or contractions at 4- to 5-minute (or more frequent) intervals and increasing in intensity within 24 hours.

 

Secondary outcomes were: the cervical dilatation was sufficient for amniotomy, cervical length and dilatation, length of labour, time from randomisation to start of active labour, postpartum bleeding, use of epidural, augmentation of contractions and instrumental delivery, as well as neonatal outcomes such as Apgar score and umbilical pH value when available.

NotesPower analysis undertaken.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskCentral computer-generated.
Allocation concealment (selection bias)Low riskPhone service.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear risk

Acupuncturist not blind.

Blinding failed in 6 cases, 2 informed by partners (evenly distributed by group). 4 randomisations and administration of treatment was undertaken by the same midwife. Most women did not know which group they were in.

Blinding of outcome assessment (detection bias)
All outcomes
Low riskPrincipal investigator and nurses gathering data were blind to group allocation.
Incomplete outcome data (attrition bias)
All outcomes
Low risk1 lost to follow-up in the acupuncture group, and 2 lost to follow-up in the control group. 12 protocol violations in the acupuncture group, and 7 in the control group.
Selective reporting (reporting bias)Low riskAll outcomes reported as per entry on trial registry.
Other biasLow riskNo imbalance at randomisation.

Rabl 2001

Methods Women were randomised to acupuncture or no acupuncture.
Participants56 women were randomised to the trial in Austria. Inclusion criteria were EDC confirmed by ultrasound, uncomplicated pregnancy, singleton pregnancy with cephalic presentation. Exclusion criteria were cervical dilatation greater than 3 cm, premature rupture of membranes, previous caesarean section, maternal complications, e.g. pre-eclampsia, fetal growth retardation. Women were randomised at term.
Interventions

All women were examined at term and at 2-day intervals thereafter. Fetal heart rate was monitored, the cervical length was measured by ultrasound, cervical mucus was obtained for fetal fibronectin test and the cervical status was assessed for the Bishops score. Women received acupuncture at term and at 2-day intervals thereafter.

Acupuncture points - LI4, and SP6 were bilaterally inserted. De qi needling sensation was achieved. Needles were left in for 20 minutes. If the woman was undelivered 10 days after her EDC labour was induced.

The control group received routine care.

OutcomesThe change in cervical length over time, time from the first fibronectin test to delivery, time period from EDC to time of delivery, number of postdate indications, length of first and second stage of labour, need for oxytocin augmentation and mode of delivery.
NotesNo sample-size calculation. Eleven (20%) women were excluded and follow-up data were not available on these women. Intention-to-treat analysis was reported.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskThe trial used a central randomisation service, with computer-generated sequence of random numbers.
Allocation concealment (selection bias)Low riskComputer generation.
Blinding of participants and personnel (performance bias)
All outcomes
High riskThe study participants were not blind to their group allocation. The care providers were blind to the woman’s study group.
Blinding of outcome assessment (detection bias)
All outcomes
High riskThe outcome assessors and statistician were not blind to group allocation.
Incomplete outcome data (attrition bias)
All outcomes
High riskThere were 11 (20%) post-randomisation exclusions and losses to follow-up.
Selective reporting (reporting bias)Unclear riskNo study protocol available.
Other biasUnclear riskLimited reporting, and unable to assess.

Romer 2000

MethodsRandomised controlled trial of acupuncture,and control using non specific acupuncture to examine the effect on cervical maturation and duration of labour. A non-randomised usual care group was recruited to the study.
Participants553 women were randomised to the trial at a Uni-centre hospital in Mannheim, Germany. Women were primiparous, with exclusion criteria stated as multiple pregnancy, placenta previa, planned caesarean section, any bleeding after 28 weeks, and any coagulation disorder.
InterventionsAcupuncture was administered weekly from 36 weeks until delivery. For the treatment group, fixed acu-points were administered including: ST36, SP6, GB34, BL67.Control acupuncture used non specific acupuncture including GC20, PC6, HT7. Points were needled using tonifying techniques, with a treatment duration of 20 minutes.
OutcomesBishop score, length of cervix, duration of labour.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskBlock randomisation using random table numbers.
Allocation concealment (selection bias)Unclear riskNo other details available.
Blinding of participants and personnel (performance bias)
All outcomes
Low riskParticipants allocated to acupuncture or the non specific acupuncture group were blind to their group allocation.
Blinding of outcome assessment (detection bias)
All outcomes
Low riskOutcome assessor blind to group allocation.
Incomplete outcome data (attrition bias)
All outcomes
Low riskThere were no drop outs.
Selective reporting (reporting bias)Unclear riskNo details available.
Other biasUnclear riskNo details available.

Selmer-Olsen 2007

MethodsThis was a randomised controlled trial to assess the effect of acupuncture on the onset of labour and the need for induction after prelabour rupture of membranes. Women were randomised to receive acupuncture or standard care.
ParticipantsThe study took place in a hospital in Norway between 2004 and 2006. 106 women were included who were nulliparous with an uneventful singleton cephalic pregnancy between 37 and 42 weeks, with confirmed rupture of membranes without contractions of the uterus.
Interventions

All women in the acupuncture group were needled at CV4. There were than diagnosed into 3 TCM categories based on their constitution. For Spleen qi deficiency, points were UB20, SP6 and ST36. For Liver qi stagnation, points were UB18, LR3, and LI4. For Kidney qi deficiency, points were UB23 and KI3. The following additional points could be used when appropriate, GVl 4, GV20, HT7, UB15, LU7, UB32, PC6, TH6. De qi was attained on all points. All Bladder channel points were needled bilaterally, the rest unilaterally. Single use needles (length: 2.5 and 4 cm) were retained for 30 minutes. Women were offered an additional treatment the following day if they were not in labour.

The control group received standard care. Standard care for nulliparas was expectant management at home for approximately 48 hours if cardiotocogram, temperature and amniotic fluid are normal, checked on a daily basis. To avoid infection, no digital examination was performed before onset of labour or induction.

OutcomesTime from PROM to active phase of labour. The active phase of labour was defined as a cervix dilatation of 3 cm and at least 2 uterine contractions in 10 minutes. The incidence of induction and additional outcomes of birth (Apgar score, epidural, oxytocin, caesarian sections, instrumental delivery) were reported. Self-reported physical well-being was registered using a 100-mm Visual Analogue Scale at randomisation and when they reached the active phase.
NotesIt is unclear who conducted the differential diagnosis to determine treatment and what instrument was used to guide the diagnosis and maximise inter-rater reliability.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskInternet based block randomisation.
Allocation concealment (selection bias)Low riskConcealed centrally.
Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants and clinicians were not blinded.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskIt was not stated if assessors were blinded.
Incomplete outcome data (attrition bias)
All outcomes
High risk5 participants were lost to follow-up, and 1 participant refused further participation. 4 participants were excluded after randomisation, 1 had meconium-stained waters, 1 did not return questionnaire, 2 had intact membranes. These participants were not included in the analysis.
Selective reporting (reporting bias)High riskThe outcomes of Apgar score, epidural, instrumental delivery, caesarean sections, inductions, dilatation, oxytocin were reported but no between group analysis was conducted.
Other biasUnclear riskBaseline characteristics were not reported.

Smith 2008

Methods Randomised controlled trial of acupuncture versus sham acupuncture sessions to estimate the effectiveness of acupuncture to induce labour.
ParticipantsThe study took place in a Women's and Children's Hospital in Australia between 1998 and 2005. 364 women aged greater than 16 years with a singleton pregnancy and cephalic presentation scheduled for a post term induction were recruited to the study. Women were excluded if they were in active labour with regular uterine contractions, or if there were contraindications to labour or vaginal birth, or if they presented with spontaneous prelabour rupture of membranes.
Interventions

The acupuncture group received acupuncture at LI4, SP6, UB31, UB32, ST36 and LR3. Any underlying pathology from a TCM framework was examined and treated with addition points, e.g. KI7, UB20, UB21, LR3. Needles were retained for 30-40 minutes with strong stimulation and de qi. Seirin 1-2 inch needles were used with a 32 gauge (0.25 mm) diameter.

The sham group received the same treatment in terms of timing and duration, but with minimal insertion and stimulation. Sham points were selected on the sacral area, hand, foot, a point below the knee and lower leg, at points that were not acupuncture points. Treatments were administered over a 2-day period before the planned induction.

Outcomes

The primary outcome was the need for induction, a reduction in the need for prostaglandins, oxytocin, and artificial rupture of membranes, change in Bishop score, time of intervention to time of delivery, and length of active labour.

Secondary: methods of pain relief, mode of birth, Apgar scores less than 7 at 5 minutes, admission of the mother and neonate from the labour ward to the postnatal ward together, meconium, non-reassuring fetal heart rate tracing, neonatal jaundice requiring phototherapy, neonatal seizures, acceptability of treatment by the mother, Bishop score, labour agentry scale of control in childbirth, likes and dislikes regarding participation in the trial.

NotesIntention-to-treat analysis was conducted. Sample size calculation reported.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskA computer-generated randomisation schedule created by an independent statistician in variable block size and stratified by parity (nulliparous and multiparous) and incorporated into a telephone randomisation service.
Allocation concealment (selection bias)Low riskA central telephone randomisation service was available 7 days a week at the recruiting hospital.
Blinding of participants and personnel (performance bias)
All outcomes
Low riskParticipants were blinded to allocation by use of sham control. Caregivers were blind to the women's study group. The treatment allocation was known only to the acupuncturist administering the intervention.
Blinding of outcome assessment (detection bias)
All outcomes
Low riskData collection was done by someone not involved in the administration of the intervention and the analyst was blind until the end of data analysis.
Incomplete outcome data (attrition bias)
All outcomes
Low riskAll patients received at least 1 session in both groups, 11 participants in the acupuncture group received only 1 treatment and 15 women in the sham acupuncture group. Reasons given were problems with childcare, feeling too tired, and lack of transportation to the trial centre. All participants were included in the analysis.
Selective reporting (reporting bias)Low riskAll outcomes reported as per trial registration.
Other biasLow risk Women in the sham group were older and there were also differences in the categorisation of the Bishop score.  The authors adjusted the primary outcomes for maternal age and the raw Bishop score.

Tremeau 1992

  1. a

    EDC: estimated date of confinement
    PROM: premature rupture of membranes
    TCM: traditional Chinese medicine
    TENS: transcutaneous nerve stimulation

MethodsRandomised controlled trial examining the effect of acupuncture on cervical maturation. Parallel design of acupuncture versus usual care and sham acupuncture.
Participants128 women met the entry criteria and were randomised. Participants were recruited from a maternity hospital in France. Women were 37-38 weeks pregnant with a Bishops score of less than 4. Exclusion criteria included; at risk of premature delivery, planned caesarean section, placenta previa, receiving concurrent treatments such as yoga, homeopathy, acupuncture.
Interventions

Acupuncture points were selected based on those used to increase cervical maturation including: CV2, CV3, CV4, Liv3, BL60, GB34, ST36, LI4, SP6, BL67. The acupuncture control was pricked with needles at sites 1 cm from the bilateral acu-point, and 1 cm from the med line points, and a third group received usual care.

Three treatment sessions were administered, with electro-stimulation for 20 minutes.

OutcomesThe Bishops score was assessed 48 hours after the last acupuncture session, duration of labour, time to 2 cm cervical dilatation.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskTable of random numbers.
Allocation concealment (selection bias)Unclear riskNot reported.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNo details were reported on whether the integrity of blinding between acupuncture and the sham group was maintained.
Blinding of outcome assessment (detection bias)
All outcomes
Low riskThe outcome assessment was undertaken by a clinician blind to group.
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk16% of women did not complete the protocol due to spontaneous labour before the second examination, 2 women declined the second examination and 1 woman did not return for acupuncture.
Selective reporting (reporting bias)Unclear riskLimited reporting unable to assess.
Other biasUnclear riskNo imbalance in baseline characteristics.

Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion
  1. a

    TENS: transcutaneous nerve stimulation

Aghamohammadi 2011This was a randomised double-blind study comparing TENS versus sham TENS on LI4 and SP6 in 64 nulliparous women who were in first stage of active labour. Labour time was found to be significantly shorter in the TENS group as was the need for oxytocin to augment labour. The trial was excluded as it did not meet the inclusion criteria of an acupuncture intervention - no needles were used and it did not have a primary outcome that met our inclusion criteria.
Bo 2006This study evaluated the role of acupuncture primarily during labour on pain relief. No data on induction outcomes were reported.
Dorr 1990The evidence regarding the clinical effectiveness of this technique is limited. This controlled clinical trial undertaken in Czechoslovakia consisted of women between 39 to 43 weeks with a cervical score greater than 5 (with no regular uterine contractions). Sixteen women received acupuncture. In 1 group electrical acupuncture commenced after the discharge of amniotic fluid (up to 4 hours); in the other group, stimulation began 6 or more hours after the discharge of amniotic fluid. Spontaneous vaginal delivery was achieved in 13 women.
Dunn 1989This comparison between electrical acupuncture stimulation or placebo acupuncture assessed the onset of uterine contractions in 20 postdate pregnant women. There was evidence of strong contractions in the treatment group. TENS does not meet the eligibility criteria for the review.
Kubista 1974This study reported on 60 pregnant women who received acupuncture (ST36, KI8, GB34 and UB 62) compared to a control of 60 pregnant women from the same clinic with a primary outcome of length of labour. The study was not randomised.
Li 1996This study was a quasi-randomised trial and was excluded.
Lyngso 2010This trial included women who were already in labour and was therefore excluded.
So 1979A controlled clinical trial was undertaken at a hospital in Hong Kong. 60 women were allocated to 3 groups: electro-acupuncture (stimulation of SP6 and LI4); acupuncture at these same points on 1 side of the body only; and thirdly, sham acupuncture. No data were available on the results of the trial.

Characteristics of studies awaiting assessment [ordered by study ID]

Liu 2012

MethodsSingle blind randomised controlled trial of electro-acupuncture on labour.
Participants38 women.
InterventionsWomen randomised to electro-acupuncture, 37 to sham acupuncture and 36 to a control.
OutcomesBlood pressure, heart rate, postpartum bleeding, Apgar score, length of labour.
NotesChinese manuscript, awaiting translation.

Characteristics of ongoing studies [ordered by study ID]

Fabio 2007

Trial name or titleEfficacy of acupuncture on induction of labour.
MethodsRandomised controlled trial.
ParticipantsWomen at 40 + 2 - 40 + 4 gestational age.
InterventionsAcupuncture versus placebo. Acupuncture administered daily from 40 + 4 for 7 days.
OutcomesTo evaluate the efficacy of acupuncture administered daily from 40 weeks + 4 days of gestation for induction of labour respect with placebo, to evaluate safety of acupuncture.
Starting dateNovember 2007. Completed January 2009.
Contact informationFacchinetti Fabio, University of Modena and Reggio Emilia, Italy.
NotesThe purpose of this study is to evaluate the efficacy and safety of acupuncture for the induction of labour in pregnant women at the 40 weeks + 4 days of gestation.

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