Chan Fei, Patabendige Malitha, Wise Michelle R, Thompson John M D, Sadler Lynn, Beckmann Michael, Henry Amanda, Jones Madeleine N, Mol Ben W, Li Wentao
Department of Obstetrics and Gynaecology, Monash University, Clayton, Victoria, Australia.
Monash Women's, Monash Health, Melbourne, Victoria, Australia.
Acta Obstet Gynecol Scand. 2025 Jun;104(6):1041-1055. doi: 10.1111/aogs.15092. Epub 2025 Mar 25.
Outpatient cervical ripening and induction of labor might offer potential benefits. There are a few randomized controlled trials (RCTs) comparing outpatient balloon catheters with inpatient vaginal dinoprostone, but the reported outcomes among these trials were inconsistent, justifying the need for a meta-analysis. We aimed to evaluate the effectiveness and safety of inpatient vaginal dinoprostone compared to outpatient balloon catheters for cervical ripening in labor induction.
Eligible RCTs were identified using MEDLINE, Emcare, Embase, Scopus, CINAHL Plus, Cochrane Pregnancy and Childbirth Group's Trials Register, WHO International Clinical Trials Registry Platform, and clinicaltrials.gov from inception to July 2024. Women with live singleton pregnancies at 34 or more weeks of gestation were eligible. The authors of eligible trials were invited to share their de-identified data. The main outcomes were vaginal birth and a composite adverse perinatal and maternal outcome. All analyses were adjusted for age and parity. Two-stage random effects meta-analysis was the main analysis strategy with the intention-to-treat principle. This meta-analysis was registered with PROSPERO (CRD42022313183) on 27-04-2022.
We identified three eligible RCTs, and all three shared data (N = 1636); inpatient vaginal dinoprostone (n = 832), outpatient balloon catheter (n = 804). The odds of vaginal birth were higher after inpatient vaginal dinoprostone than outpatient balloon catheter (67.8% vs 61.7%, adjusted odds ratio [aOR] 1.30, 95% CI 1.05-1.62, I = 0%). There was no significant difference in the composite adverse perinatal outcome (13.7% vs 13.1%, aOR 1.09, 95% CI 0.75-1.58, I = 28.7%) or the composite adverse maternal outcome (16.6% vs 19.8%, aOR 0.81, 95% CI 0.61-1.07, I = 11.5%). The difference in effect on vaginal birth rate varied according to body mass index. Overweight and obese women had a lower vaginal birth rate after outpatient induction, whereas for those with underweight/normal weight, the rates of vaginal birth were similar.
Balloon catheter used in an outpatient labor induction setting probably leads to fewer vaginal births compared to vaginal dinoprostone in an inpatient setting. In pre-planned subgroup analysis, for pregnant women with underweight/normal weight, both inpatient vaginal dinoprostone and outpatient balloon catheter methods are viable options, but balloon catheter has a lower vaginal birth rate in women with overweight and obesity during pregnancy. The perinatal and maternal safety profiles are comparable.
门诊宫颈成熟度评估及引产可能具有潜在益处。有一些随机对照试验（RCT）比较了门诊球囊导管与住院使用阴道地诺前列酮的效果，但这些试验报告的结果并不一致，因此有必要进行荟萃分析。我们旨在评估住院使用阴道地诺前列酮与门诊球囊导管用于引产时宫颈成熟度评估的有效性和安全性。
从创刊至2024年7月，通过MEDLINE、Emcare、Embase、Scopus、CINAHL Plus、Cochrane妊娠与分娩组试验注册库、世界卫生组织国际临床试验注册平台及clinicaltrials.gov识别符合条件的RCT。妊娠34周及以上的单胎活产孕妇符合条件。邀请符合条件试验的作者分享去识别化数据。主要结局为阴道分娩以及围产期和产妇综合不良结局。所有分析均对年龄和胎次进行了调整。采用两阶段随机效应荟萃分析作为主要分析策略，并遵循意向性分析原则。该荟萃分析于2022年4月27日在PROSPERO（CRD42022313183）注册。
我们识别出三项符合条件的RCT，且所有三项均共享了数据（N = 1636）；住院使用阴道地诺前列酮组（n = 832），门诊球囊导管组（n = 804）。住院使用阴道地诺前列酮后阴道分娩的几率高于门诊球囊导管组（67.8% 对61.7%，调整后优势比[aOR] 1.30，95%置信区间[CI] 1.05 - 1.62，I² = 0%）。围产期综合不良结局无显著差异（13.7% 对13.1%，aOR 1.09，95% CI 0.75 - 1.58，I² = 28.7%）或产妇综合不良结局无显著差异（16.6% 对19.8%，aOR 0.81，95% CI 0.61 - 1.07，I² = 11.5%）。对阴道分娩率的影响差异因体重指数而异。超重和肥胖女性门诊引产后宫内分娩率较低，而体重过轻/正常体重的女性，阴道分娩率相似。
与住院使用阴道地诺前列酮相比，门诊引产使用球囊导管可能导致阴道分娩的情况较少。在预先计划的亚组分析中，对于体重过轻/正常体重的孕妇，住院使用阴道地诺前列酮和门诊球囊导管方法都是可行的选择，但妊娠期间超重和肥胖的女性使用球囊导管后宫内分娩率较低。围产期和产妇安全性相当。
