PDF(Pubmed)
Abstract：
Evidence comparing double-balloon vs single-balloon catheter for induction of labor is divided. We aim to compare the efficacy and safety of double-vs single-balloon catheters using individual participant data.
A search of Ovid MEDLINE, Embase, Ovid Emcare, CINAHL Plus, Scopus, and clinicaltrials.gov was conducted for randomized controlled trials published from March 2019 until April 13, 2021. Earlier trials were identified from the Cochrane Review on Mechanical Methods for Induction of Labour. Randomized controlled trials that compared double-balloon with single-balloon catheters for induction of labor in singleton gestations were eligible. Participant-level data were sought from trial investigators and an individual participant data meta-analysis was performed. The primary outcomes were rates of vaginal birth achieved, a composite measure of adverse maternal outcomes and a composite measure of adverse perinatal outcomes. We used a two-stage random-effects model. Data were analyzed from the intention-to-treat perspective.
Of the eight eligible randomized controlled trials, three shared individual-level data with a total of 689 participants, 344 women in the double-balloon catheter group and 345 women in the single-balloon catheter group. The difference in the rate of vaginal birth between double-balloon catheter and single-balloon catheter was not statistically significant (relative risk [RR] 0.93, 95% confidence interval [CI] 0.86-1.00, p = 0.050; I2 0%; moderate-certainty evidence). Both perinatal outcomes (RR 0.81, 95% CI 0.54-1.21, p = 0.691; I2 0%; moderate-certainty evidence) and maternal composite outcomes (RR 0.65, 95% CI 0.15-2.87, p = 0.571; I2 55.46%; low-certainty evidence) were not significantly different between the two groups.
Single-balloon catheter is at least comparable to double-balloon catheter in terms of vaginal birth rate and maternal and perinatal safety outcomes.
A search of Ovid MEDLINE, Embase, Ovid Emcare, CINAHL Plus, Scopus, and clinicaltrials.gov was conducted for randomized controlled trials published from March 2019 until April 13, 2021. Earlier trials were identified from the Cochrane Review on Mechanical Methods for Induction of Labour. Randomized controlled trials that compared double-balloon with single-balloon catheters for induction of labor in singleton gestations were eligible. Participant-level data were sought from trial investigators and an individual participant data meta-analysis was performed. The primary outcomes were rates of vaginal birth achieved, a composite measure of adverse maternal outcomes and a composite measure of adverse perinatal outcomes. We used a two-stage random-effects model. Data were analyzed from the intention-to-treat perspective.
Of the eight eligible randomized controlled trials, three shared individual-level data with a total of 689 participants, 344 women in the double-balloon catheter group and 345 women in the single-balloon catheter group. The difference in the rate of vaginal birth between double-balloon catheter and single-balloon catheter was not statistically significant (relative risk [RR] 0.93, 95% confidence interval [CI] 0.86-1.00, p = 0.050; I2 0%; moderate-certainty evidence). Both perinatal outcomes (RR 0.81, 95% CI 0.54-1.21, p = 0.691; I2 0%; moderate-certainty evidence) and maternal composite outcomes (RR 0.65, 95% CI 0.15-2.87, p = 0.571; I2 55.46%; low-certainty evidence) were not significantly different between the two groups.
Single-balloon catheter is at least comparable to double-balloon catheter in terms of vaginal birth rate and maternal and perinatal safety outcomes.
摘要：
背景：比较双气囊与单气囊导管引产的证据存在分歧。我们旨在使用个体参与者数据比较双球囊导管与单球囊导管的疗效和安全性。
方法：搜索OvidMEDLINE，Embase,OvidEmcare,CINAHLPlus,Scopus,和clinicaltrials.gov进行了从2019年3月至2021年4月13日发表的随机对照试验。早期的试验是从Cochrane评论中确定的机械引产方法。比较双气囊和单气囊导尿管在单胎妊娠引产的随机对照试验是合格的。从试验研究者那里寻求参与者水平的数据，并进行个体参与者数据荟萃分析。主要结果是达到的阴道分娩率，孕产妇不良结局的复合指标和围产期不良结局的复合指标.我们使用了两阶段随机效应模型。从意向治疗的角度分析数据。
结果：在8项符合条件的随机对照试验中，三个共享个人层面的数据，共有689名参与者，双球囊导管组344名女性和单球囊导管组345名女性。双气囊导管和单气囊导管的阴道分娩率差异无统计学意义(相对危险度[RR]0.93,95%置信区间[CI]0.86-1.00,p=0.050;I20%;中等确定性证据)。两组围产期结局（RR0.81，95％CI0.54-1.21，p=0.691；I20％；中度确定性证据）和产妇综合结局（RR0.65，95％CI0.15-2.87，p=0.571；I255.46％；低确定性证据）均无显著差异。
结论：单球囊导管在阴道分娩率和孕产妇及围产期安全结局方面至少与双球囊导管相当。
方法：搜索OvidMEDLINE，Embase,OvidEmcare,CINAHLPlus,Scopus,和clinicaltrials.gov进行了从2019年3月至2021年4月13日发表的随机对照试验。早期的试验是从Cochrane评论中确定的机械引产方法。比较双气囊和单气囊导尿管在单胎妊娠引产的随机对照试验是合格的。从试验研究者那里寻求参与者水平的数据，并进行个体参与者数据荟萃分析。主要结果是达到的阴道分娩率，孕产妇不良结局的复合指标和围产期不良结局的复合指标.我们使用了两阶段随机效应模型。从意向治疗的角度分析数据。
结果：在8项符合条件的随机对照试验中，三个共享个人层面的数据，共有689名参与者，双球囊导管组344名女性和单球囊导管组345名女性。双气囊导管和单气囊导管的阴道分娩率差异无统计学意义(相对危险度[RR]0.93,95%置信区间[CI]0.86-1.00,p=0.050;I20%;中等确定性证据)。两组围产期结局（RR0.81，95％CI0.54-1.21，p=0.691；I20％；中度确定性证据）和产妇综合结局（RR0.65，95％CI0.15-2.87，p=0.571；I255.46％；低确定性证据）均无显著差异。
结论：单球囊导管在阴道分娩率和孕产妇及围产期安全结局方面至少与双球囊导管相当。
