Gomez Slagle Helen B, Fonge Yaneve N, Caplan Richard, Pfeuti Courtney K, Sciscione Anthony C, Hoffman Matthew K
Department of Obstetrics and Gynecology, Christiana Care Health System, Newark, DE.
Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Pittsburgh Medical Center, Pittsburg, PA.
Am J Obstet Gynecol. 2022 May;226(5):724.e1-724.e9. doi: 10.1016/j.ajog.2021.11.1368. Epub 2022 Feb 6.
Early amniotomy shortens the duration of spontaneous labor, yet there is no clear evidence on the optimal timing of amniotomy following cervical ripening. There are limited high-quality studies on the use of early amniotomy intervention following labor induction.
This study aimed to evaluate whether amniotomy within 1 hour of Foley catheter expulsion reduces the duration of labor among individuals undergoing combined misoprostol and Foley catheter labor induction at term.
This was a randomized clinical trial conducted from November 2020 to May 2021 comparing amniotomy within 1 hour of Foley catheter expulsion (early artificial rupture of membranes) with expectant management. Randomization was stratified by parity. Labor management was standardized among participants. Individuals undergoing induction at ≥37 weeks with a singleton gestation and needing cervical ripening were eligible. Our primary outcome was time to delivery. Wilcoxon rank sum, Pearson chi-square, and Cox survival analyses with intent-to-treat principles were performed adjusting for age, body mass index, parity, mode of delivery, Bishop score, and the interaction between randomization group and parity. A sample size of 160 was planned to detect a 4-hour reduction in delivery time.
A total of 160 patients (79 early artificial rupture of membranes, 81 expectant management) were randomized. Early artificial rupture of membranes achieved a faster median time to delivery than expectant management (early artificial rupture of membranes: 11.1 hours; interquartile range, 6.25-17.1 vs expectant management: 19.8 hours; interquartile range, 13.2-26.2; P<.001). A greater percentage of individuals in the early artificial rupture of membranes group delivered within 24 hours (86% vs 70%; P=.03). There was no difference in the cesarean delivery rate between the 2 groups (22% vs 31%; P=.25). Individuals delivered 2.3 times faster following early artificial rupture of membranes (hazard ratio, 2.3; 95% confidence interval, 1.5-3.4; P<.001). There were no significant differences in maternal and neonatal outcomes.
Amniotomy within 1 hour of Foley catheter expulsion resulted in 2.3 times faster delivery than expectant management. Therefore, early artificial rupture of membranes should be considered in individuals undergoing mechanical cervical ripening at term.
早期人工破膜可缩短自然分娩的时长，但对于宫颈成熟后人工破膜的最佳时机，尚无明确证据。关于引产术后早期人工破膜干预的高质量研究有限。
本研究旨在评估在福莱氏尿管排出后1小时内进行人工破膜，是否能缩短足月接受米索前列醇与福莱氏尿管联合引产者的分娩时长。
这是一项于2020年11月至2021年5月开展的随机临床试验，比较福莱氏尿管排出后1小时内进行人工破膜（早期人工破膜）与期待治疗。随机分组按产次分层。参与者的分娩管理进行了标准化。孕周≥37周、单胎妊娠且需要宫颈成熟的引产者符合入选标准。我们的主要结局是分娩时间。采用Wilcoxon秩和检验、Pearson卡方检验以及意向性分析的Cox生存分析，并对年龄、体重指数、产次、分娩方式、Bishop评分以及随机分组与产次之间的交互作用进行校正。计划样本量为160例，以检测分娩时间缩短4小时的差异。
共160例患者被随机分组（79例早期人工破膜，81例期待治疗）。早期人工破膜组的中位分娩时间比期待治疗组更快（早期人工破膜组：11.1小时；四分位数间距，6.25 - 17.1 vs期待治疗组：19.8小时；四分位数间距，13.2 - 26.2；P <.001）。早期人工破膜组中更大比例的个体在24小时内分娩（86% vs 70%；P =.03）。两组的剖宫产率无差异（22% vs 31%；P =.25）。早期人工破膜后个体分娩速度快2.3倍（风险比，2.3；95%置信区间，1.5 - 3.4；P <.001）。母婴结局无显著差异。
福莱氏尿管排出后1小时内进行人工破膜，分娩速度比期待治疗快2.3倍。因此，对于足月接受机械性宫颈成熟的个体，应考虑早期人工破膜。
