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用于引产的球囊导管与阴道前列腺素对比研究(CPI协作组):一项随机对照试验的个体参与者数据荟萃分析

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

作者信息

Jones Madeleine N, Palmer Kirsten R, Pathirana Maleesa M, Cecatti Jose Guilherme, Filho Olimpio B Moraes, Marions Lena, Edlund Måns, Prager Martina, Pennell Craig, Dickinson Jan E, Sass Nelson, Jozwiak Marta, Eikelder Mieke Ten, Rengerink Katrien Oude, Bloemenkamp Kitty W M, Henry Amanda, Løkkegaard Ellen C L, Christensen Ib Jarle, Szychowski Jeff M, Edwards Rodney K, Beckmann Michael, Diguisto Caroline, Gouge Amélie Le, Perrotin Franck, Symonds Ian, O'Leary Sean, Rolnik Daniel L, Mol Ben W, Li Wentao

机构信息

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.

出版信息

Lancet. 2022 Nov 12;400(10364):1681-1692. doi: 10.1016/S0140-6736(22)01845-1.

Abstract

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 We systematically identified published and unpublished randomised controlled trials that completed data collection between March 19, 2019, and May 1, 2021, by searching the Cochrane Library, ClinicalTrials.gov, WHO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; I=0%), caesarean delivery for failure to progress (11 trials, 4601 women; aOR 1·20, 95% CI 0·91-1·58; I=39%), or caesarean delivery for fetal distress (10 trials, 4441 women; aOR 0·86, 95% CI 0·71-1·04; I=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; I=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; I=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.

摘要

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被广泛用于引产时的宫颈成熟。我们旨在比较这两种引产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的荟萃分析,比较球囊导管和阴道前列腺素在引产前行宫颈成熟的效果。我们通过检索Cochrane图书馆、ClinicalTrials.gov、世界卫生组织国际临床试验注册平台和PubMed,系统地识别了在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综述确定了2019年3月19日之前进行的进一步试验。不包括两种方法联合使用的数据,仅分析来自单胎存活妊娠女性的数据,且不根据产次或胎膜状态进行排除。我们联系了各个试验的作者,并根据预定义的变量定义对参与者水平的数据进行了统一和重新编码。使用ROB2工具评估偏倚风险。主要结局包括剖宫产、剖宫产指征、复合围产期不良结局和复合孕产妇不良结局。主要分析遵循意向性分析原则。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。所有模型均对产妇年龄和产次进行了调整。这项荟萃分析已在PROSPERO(CRD42020179924)注册。

结果

12项研究提供了个体参与者数据,共有5460名参与者。与阴道前列腺素相比,球囊导管导致的剖宫产率(12项试验,5414名女性;粗发病率27.0%;调整后比值比[aOR]1.09,95%置信区间0.95-1.24;I²=0%)、因产程无进展而行剖宫产的比例(11项试验,4601名女性;aOR 1.20,95%置信区间0.91-1.58;I²=39%)或因胎儿窘迫而行剖宫产的比例(10项试验,4441名女性;aOR 0.86,95%置信区间0.71-1.04;I²=0%)无显著差异。分配到球囊导管组的女性的复合围产期不良结局低于分配到阴道前列腺素组的女性(10项试验,4452名新生儿,粗发病率13.6%;aOR 0.80,95%置信区间0.70-0.92;I²=0%)。复合孕产妇不良结局无显著差异(10项试验,4326名女性,粗发病率22.7%;aOR 1.02,95%置信区间0.89-1.18;I²=0%)。

解读

在引产中,球囊导管和阴道前列腺素的剖宫产率和孕产妇安全性相当,但球囊导管导致的围产期不良事件较少。

资金来源

澳大利亚国家卫生与医学研究委员会和莫纳什健康新兴研究员奖学金。

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