Balloon catheters versus vaginal prostaglandins for labour induction (CPI Collaborative): an individual participant data meta-analysis of randomised controlled trials,The Lancet

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Balloon catheters versus vaginal prostaglandins for labour induction (CPI Collaborative): an individual participant data meta-analysis of randomised controlled trials
The Lancet ( IF 98.4 ) Pub Date : 2022-11-10 , DOI: 10.1016/s0140-6736(22)01845-1
Madeleine N Jones ₁ , Kirsten R Palmer ₁ , Maleesa M Pathirana ₂ , Jose Guilherme Cecatti ₃ , Olimpio B Moraes Filho ₄ , Lena Marions ₅ , Måns Edlund ₅ , Martina Prager ₅ , Craig Pennell ₆ , Jan E Dickinson ₇ , Nelson Sass ₈ , Marta Jozwiak ₉ , Mieke Ten Eikelder ₁₀ , Katrien Oude Rengerink ₁₁ , Kitty W M Bloemenkamp ₁₂ , Amanda Henry ₁₃ , Ellen C L Løkkegaard ₁₄ , Ib Jarle Christensen ₁₅ , Jeff M Szychowski ₁₆ , Rodney K Edwards ₁₇ , Michael Beckmann ₁₈ , Caroline Diguisto ₁₉ , Amélie Le Gouge ₁₉ , Franck Perrotin ₁₉ , Ian Symonds ₂₀ , Sean O'Leary ₂₁ , Daniel L Rolnik ₁ , Ben W Mol ₂₂ , Wentao Li ₁

Affiliation

Department of Obstetrics and Gynaecology, Monash University, Monash Medical Centre, Clayton, VIC, Australia.
Adelaide Medical School and Robinson Research Institute, The University of Adelaide, Adelaide, SA, Australia.
State University of Campinas, São Paulo, Brazil.
Faculdade de Ciencias Médicas, University of Pernambuco, Pernambuco, Brazil.
Department of Clinical Science and Education, Karolinska Institutet, Stockholm, Sweden.
School of Medicine and Public Health, The University of Newcastle, Callaghan, NSW, Australia.
School of Women's and Infants' Health, University of Western Australia, Perth, WA, Australia.
Departamento de Obstetricia, Universidade Federal de São Paulo, São Paulo, Brazil.
Gynaecologic Oncology, Erasmus University Medical Centre, Rotterdam, Netherlands.
Department of Gynaecology, Leiden University Medical Centre, Leiden, Netherlands.
Department of Biostatistics and Research Support, Julius Center for Health Sciences and Primary Care, UMC Utrecht, Utrecht, Netherlands.
Department of Obstetrics, WKZ Birth Centre, Division Woman and Baby, UMC Utrecht, Utrecht, Netherlands.
Medicine & Health, University of New South Wales, Kensington, NSW, Australia.
Department of Gynaecology and Obstetrics, Nordsjællands Hospital, Hillerød, Denmark.
University of Copenhagen, Copenhagen Biocentre, Copenhagen, Denmark.
School of Public Health, University of Alabama at Birmingham, Birmingham, AL, USA.
College of Medicine, University of Oklahoma, Oklahoma City, OK, USA.
Mothers, Babies and Women's Health Services, Mater Health, South Brisbane, QLD, Australia.
Department of Obstetrics, Gynaecology and Fetal Medicine, Centre Hospitalier Régional Universitaire de Tours, Tours, France.
School of Medicine, International Medical University, Kuala Lumpur, Malaysia.
Robinson Research Institute, University of Adelaide, Adelaide, SA, Australia.
Department of Obstetrics and Gynaecology, Monash University, Monash Medical Centre, Clayton, VIC, Australia; Aberdeen Centre for Women's Health Research, School of Medicine, University of Aberdeen, Aberdeen, UK.

Background

Induction of labour is one of the most common obstetric interventions globally. Balloon catheters and vaginal prostaglandins are widely used to ripen the cervix in labour induction. We aimed to compare the effectiveness and safety profiles of these two induction methods.

Methods

We did an individual participant data meta-analysis comparing balloon catheters and vaginal prostaglandins for cervical ripening before labour induction. We systematically identified published and unpublished randomised controlled trials that completed data collection between March 19, 2019, and May 1, 2021, by searching the Cochrane Library, ClinicalTrials.gov, WHO International Clinical Trials Registry Platform, and PubMed. Further trials done before March 19, 2019, were identified through a recent Cochrane review. Data relating to the combined use of the two methods were not included, only data from women with a viable, singleton pregnancy were analysed, and no exclusion was made based on parity or membrane status. We contacted authors of individuals trials and participant-level data were harmonised and recoded according to predefined definitions of variables. Risk of bias was assessed with the ROB2 tool. The primary outcomes were caesarean delivery, indication for caesarean delivery, a composite adverse perinatal outcome, and a composite adverse maternal outcome. We followed the intention-to-treat principle for the main analysis. The primary meta-analysis used two-stage random-effects models and the sensitivity analysis used one-stage mixed models. All models were adjusted for maternal age and parity. This meta-analysis is registered with PROSPERO (CRD42020179924).

Findings

Individual participant data were available from 12 studies with a total of 5460 participants. Balloon catheters, compared with vaginal prostaglandins, did not lead to a significantly different rate of caesarean delivery (12 trials, 5414 women; crude incidence 27·0%; adjusted OR [aOR] 1·09, 95% CI 0·95–1·24; I²=0%), caesarean delivery for failure to progress (11 trials, 4601 women; aOR 1·20, 95% CI 0·91–1·58; I²=39%), or caesarean delivery for fetal distress (10 trials, 4441 women; aOR 0·86, 95% CI 0·71–1·04; I²=0%). The composite adverse perinatal outcome was lower in women who were allocated to balloon catheters than in those allocated to vaginal prostaglandins (ten trials, 4452 neonates, crude incidence 13·6%; aOR 0·80, 95% CI 0·70–0·92; I²=0%). There was no significant difference in the composite adverse maternal outcome (ten trials, 4326 women, crude incidence 22·7%; aOR 1·02, 95% CI 0·89–1·18; I²=0%).

Interpretation

In induction of labour, balloon catheters and vaginal prostaglandins have comparable caesarean delivery rates and maternal safety profiles, but balloon catheters lead to fewer adverse perinatal events.

Funding

Australian National Health and Medical Research Council and Monash Health Emerging Researcher Fellowship.

中文翻译：

球囊导管与阴道前列腺素引产（CPI 协作）：随机对照试验的个体参与者数据荟萃分析

背景

引产是全球最常见的产科干预措施之一。球囊导管和阴道前列腺素在引产中被广泛用于使子宫颈成熟。我们旨在比较这两种诱导方法的有效性和安全性。

方法

我们进行了一项个体参与者数据荟萃分析，比较了引产前宫颈成熟时球囊导管和阴道前列腺素的作用。我们通过搜索 Cochrane 图书馆、ClinicalTrials.gov、WHO 国际临床试验注册平台和 PubMed，系统地确定了在 2019 年 3 月 19 日至 2021 年 5 月 1 日期间完成数据收集的已发表和未发表的随机对照试验。通过最近的 Cochrane 审查确定了在 2019 年 3 月 19 日之前完成的进一步试验。不包括与联合使用这两种方法有关的数据，仅分析了来自单胎妊娠的存活妇女的数据，并且未根据胎次或胎膜状态进行排除。我们联系了个人试验的作者，并根据预定义的变量定义对参与者水平的数据进行了协调和重新编码。使用 ROB2 工具评估偏倚风险。主要结局是剖腹产、剖宫产指征、复合不良围产期结局和复合不良孕产妇结局。我们遵循意向性治疗原则进行主要分析。主要荟萃分析使用两阶段随机效应模型，敏感性分析使用一阶段混合模型。所有模型都针对产妇年龄和胎次进行了调整。此荟萃分析已在 PROSPERO (CRD42020179924) 注册。和复合的不良母体结果。我们遵循意向性治疗原则进行主要分析。主要荟萃分析使用两阶段随机效应模型，敏感性分析使用一阶段混合模型。所有模型都针对产妇年龄和胎次进行了调整。此荟萃分析已在 PROSPERO (CRD42020179924) 注册。和复合的不良母体结果。我们遵循意向性治疗原则进行主要分析。主要荟萃分析使用两阶段随机效应模型，敏感性分析使用一阶段混合模型。所有模型都针对产妇年龄和胎次进行了调整。此荟萃分析已在 PROSPERO (CRD42020179924) 注册。

发现

个体参与者数据来自 12 项研究，共有 5460 名参与者。球囊导管与阴道前列腺素相比，剖宫产率没有显着差异（12 项试验，5414 名妇女；粗发生率 27·0%；调整后的 OR [aOR] 1·09，95% CI 0·95–1 ·24；I ² =0%），因进展失败而剖腹产（11 项试验，4601 名妇女；aOR 1·20，95% CI 0·91–1·58；I ² =39%），或剖腹产胎儿窘迫（10 项试验，4441 名妇女；aOR 0·86，95% CI 0·71–1·04；I ²=0%）。分配给球囊导管的妇女的围产期复合不良结局低于分配给阴道前列腺素的妇女（10 项试验，4452 名新生儿，粗发生率 13·6%；aOR 0·80，95% CI 0·70–0· 92；I ² =0%）。复合不良母体结果没有显着差异（10 项试验，4326 名妇女，粗发生率 22·7%；aOR 1·02，95% CI 0·89–1·18；I 2 =0 % ^）。