Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Brigham and Women's Hospital, Boston, MA.
Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Brigham and Women's Hospital, Boston, MA.
Am J Obstet Gynecol. 2021 Jun;224(6):611.e1-611.e8. doi: 10.1016/j.ajog.2021.03.021. Epub 2021 Mar 23.
Induction of labor is common in the United States. Multiple previous studies have tried to outline a faster time to delivery to improve maternal and fetal outcomes.
This study aimed to evaluate whether women who undergo induction of labor with a single-balloon catheter and oxytocin have a shorter time to delivery with planned removal of the catheter at 6 vs 12 hours.
In this randomized controlled trial, induction of labor was performed using a combination of single-balloon catheter and oxytocin. Term women, both nulliparous and multiparous, aged 18 to 50 years old with cephalic singletons were included if they were undergoing induction of labor with a Bishop score of <6 and cervical dilation of <2 cm. Women were randomized to planned removal of the single-balloon catheter at 6 hours vs 12 hours. The primary outcome was time from catheter insertion to delivery. We were powered to show a 4-hour time difference with a sample size of 89 women per group (n=178). Planned sensitivity analyses were performed to account for cesarean delivery in labor.
From February 2019 to June 2020, 237 women were screened, 178 women were randomized, and 177 women were included in the final analysis (89 women in the 6-hour group and 88 women in the 12-hour group). Insertion to delivery time was significantly shorter in the 6-hour group (19.2 vs 24.3 hours; P=.04), and the proportion of women delivered by 24 hours was significantly greater in the 6-hour group (67.4% vs 47.4%; P<.01). There was no difference in the Bishop score at removal of the catheter or secondary maternal or neonatal outcomes. In a Cox proportional-hazards model censoring for cesarean delivery, the 6-hour group had a significantly shorter insertion to delivery time (hazard ratio, 0.67; P=.02).
Induction of labor with a single-balloon catheter and oxytocin with planned removal of the catheter at 6 hours rather than 12 hours results in a shorter time from insertion to delivery without increasing the rate of cesarean delivery. Decreasing the length of time a single-balloon catheter is in place should be considered in clinical protocols.
在美国，引产是很常见的。先前有多项研究试图概述更快的分娩时间，以改善母婴结局。
本研究旨在评估与计划在 6 小时而非 12 小时时取出导管相比，使用单球囊导管和催产素引产的女性的分娩时间是否更短。
在这项随机对照试验中，使用单球囊导管和催产素联合进行引产。纳入年龄在 18 至 50 岁、头位单胎、无剖宫产史且 Bishop 评分<6、宫颈扩张<2cm 的初产妇和经产妇。将这些女性随机分为计划在 6 小时或 12 小时时取出单球囊导管。主要结局是从导管插入到分娩的时间。我们有能力显示出 4 小时的时间差异，每组样本量为 89 名女性（n=178）。进行了计划的敏感性分析，以考虑分娩中的剖宫产。
从 2019 年 2 月至 2020 年 6 月，共有 237 名女性接受了筛查，178 名女性被随机分组，177 名女性被纳入最终分析（6 小时组 89 名女性，12 小时组 88 名女性）。6 小时组的插入到分娩时间明显更短（19.2 小时与 24.3 小时；P=.04），6 小时组在 24 小时内分娩的女性比例明显更高（67.4%与 47.4%；P<.01）。取出导管时的 Bishop 评分或次要母婴结局无差异。在对剖宫产进行校正的 Cox 比例风险模型中，6 小时组的插入到分娩时间明显更短（风险比，0.67；P=.02）。
与计划在 12 小时时取出导管相比，使用单球囊导管和催产素引产并计划在 6 小时时取出导管可缩短从插入到分娩的时间，而不会增加剖宫产率。在临床方案中应考虑缩短单球囊导管的放置时间。
