Unit of Maternal-Fetal Medicine, Department of Obstetrics, Miguel Servet University Hospital, Zaragoza, Spain.
Acta Obstet Gynecol Scand. 2019 Jul;98(7):913-919. doi: 10.1111/aogs.13556. Epub 2019 Feb 24.
The aim of this study was to compare the efficacy and safety of a low-dose protocol of vaginal misoprostol and vaginal dinoprostone insert for induction of labor in women with post-term pregnancies.
We designed a prospective, randomized, open-labeled trial with evaluators blinded to the end-point, including women of at least 41 weeks of gestational age with uncomplicated singleton pregnancies and a Bishop score <6. They were randomized into dinoprostone or misoprostol groups in a 1:1 ratio. Baseline maternal data and perinatal outcomes were recorded for statistical analysis. Successful vaginal delivery within 24 hours was the primary outcome variable. A P value <0.05 was considered statistically significant. This study was registered in ClinicalTrials.gov (number NTC03744364).
We included 198 women for analysis (99 women in each group). Vaginal birth rate within 24 hours did not differ between groups (49.5% vs 42.4%; P = 0.412). When the Bishop score was <4, dinoprostone insert showed a higher probability of vaginal delivery within 12 hours (17.8% vs 4%; P = 0.012). In the dinoprostone group, removal of the insert was more likely to be due to an adverse event (5.1% vs 14.1%; P = 0.051) and an abnormal fetal heart rate pattern during active labor (44.4% vs 58.6%; P = 0.047). Both groups were similar in neonatal outcomes including Apgar score, umbilical cord pH and neonatal intensive care unit admission.
Low-dose vaginal misoprostol and vaginal dinoprostone insert seem to be equally effective and safe for induction of labor in pregnant women with a gestational age beyond 41 weeks.
本研究旨在比较小剂量阴道米索前列醇和阴道地诺前列酮栓用于足月妊娠引产的疗效和安全性。
我们设计了一项前瞻性、随机、开放标签试验，评估者对终点设盲，纳入至少 41 孕周、单胎妊娠、Bishop 评分<6 的孕妇。按 1:1 比例随机分为地诺前列酮或米索前列醇组。记录基线产妇数据和围产结局进行统计学分析。24 小时内阴道分娩成功为主要结局变量。P 值<0.05 认为具有统计学意义。本研究在 ClinicalTrials.gov 注册（编号 NTC03744364）。
我们纳入了 198 名孕妇进行分析（每组 99 名）。两组 24 小时内阴道分娩率无差异（49.5%比 42.4%；P=0.412）。当 Bishop 评分<4 分时，地诺前列酮栓在 12 小时内阴道分娩的可能性更高（17.8%比 4%；P=0.012）。地诺前列酮组中，因不良事件（5.1%比 14.1%；P=0.051）和活跃期胎心异常（44.4%比 58.6%；P=0.047）取出栓的可能性更大。两组新生儿结局包括 Apgar 评分、脐动脉 pH 值和新生儿重症监护室入院率均相似。
对于 41 周以上妊娠的孕妇，小剂量阴道米索前列醇和阴道地诺前列酮栓用于引产似乎同样有效且安全。
