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宫颈成熟。我们的目的是比较这两种诱导方法的有效性和安全性。

个体参与者数据来自12项研究，共计5460名参与者。与阴道前列腺素相比，球囊导管未导致显著差异的剖宫产率(12项试验，5,414名女性;粗发病率为27.0%;校正（OR=1.09, 95% CI 0.95 ~ 1.24; I2=0%)、疾病进展失败的剖宫产(11项试验，4601名女性;aOR 1.20, 95% CI 0.91 ~ 1.58; I2=0%)，或胎儿窘迫的剖宫产(10项试验，4,441名女性;aOR 0.86, 95% CI 0.71 ~ 1.04; I2=0%)。

在引产中，球囊导管和阴道前列腺素具有相当的剖腹产率和产妇安全状况，但球囊导管导致较少的不良围产期事件。

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 We systematically identified published and unpublished randomised controlled trials that completed data collection between March 19, 2019, and May 1, 2021, by searching the Cochrane Library, ClinicalTrials.gov, WHO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; 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.

文章连接：

www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)01845-1/fulltext

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