Department of Obstetrics and Gynecology, Columbia University Irving Medical Center, New York, New York; the Department of Obstetrics and Gynecology, University of Texas Medical Branch at Galveston, Galveston, Texas; and NEOX s.r.o., Prague, Czech Republic.
Obstet Gynecol. 2022 Jun 1;139(6):1083-1091. doi: 10.1097/AOG.0000000000004799. Epub 2022 May 2.
To evaluate whether a synthetic osmotic cervical dilator is noninferior to oral misoprostol for cervical ripening.
In an open-label, noninferiority randomized trial, pregnant women undergoing induction of labor at 37 weeks of gestation or more with Bishop scores less than 6 were randomized to either mechanical cervical dilation or oral misoprostol. Participants in the mechanical dilation group underwent insertion of synthetic osmotic cervical dilator rods, and those in the misoprostol group received up to six doses of 25 micrograms orally every 2 hours. After 12 hours of ripening, oxytocin was initiated, with artificial rupture of membranes. Management of labor was at the physician's discretion. The primary outcome was the proportion of women achieving vaginal delivery within 36 hours of initiation of study intervention. Secondary outcomes included increase in Bishop score, mode of delivery, induction-to-delivery interval, total length of hospital stay, and patient satisfaction. On the basis of a noninferiority margin of 10%, an expected primary outcome frequency of 65% for misoprostol and 71% for mechanical methods, and 85% power, a sample size of 306 participants was needed.
From November 2018 through January 2021, 307 women were randomized, with 151 evaluable participants in the synthetic osmotic cervical dilator group and 152 in the misoprostol group (there were four early withdrawals). The proportion of women achieving vaginal delivery within 36 hours was higher with mechanical cervical dilation compared with misoprostol (61.6% vs 59.2%), with an absolute difference of 2.4% (95% CI -9% to 13%), indicating noninferiority for the prespecified margin. No differences were noted in the mode of delivery. Tachysystole was more frequent in the misoprostol group (70 [46.4%] vs 35 [23.3%]; P=.01). Participants in the synthetic osmotic cervical dilator group reported better sleep, less unpleasant abdominal sensations, and lower pain scores (P<.05).
Synthetic osmotic cervical dilator is noninferior to oral misoprostol for cervical ripening. Advantages of synthetic osmotic cervical dilator include a better safety profile and patient satisfaction, less tachysystole, lower pain scores, and U.S. Food and Drug Administration approval.
ClinicalTrials.gov, NCT03670836.
Medicem Technology s.r.o., Czech Republic.
评估合成渗透宫颈扩张器在宫颈成熟方面是否不劣于口服米索前列醇。
在一项开放性、非劣效性随机试验中，孕 37 周及以上、Bishop 评分<6 分的孕妇接受诱导分娩，随机分为机械性宫颈扩张组或口服米索前列醇组。机械性宫颈扩张组的参与者接受合成渗透宫颈扩张棒的插入，米索前列醇组的参与者每 2 小时口服 25 微克，最多 6 剂。宫颈成熟 12 小时后，开始使用催产素，并人工破膜。分娩管理由医生决定。主要结局是研究干预开始后 36 小时内阴道分娩的妇女比例。次要结局包括 Bishop 评分增加、分娩方式、引产至分娩的间隔时间、总住院时间和患者满意度。基于非劣效性边界 10%、预期米索前列醇的主要结局频率为 65%、机械方法为 71%和 85%的功效，需要 306 名参与者的样本量。
2018 年 11 月至 2021 年 1 月，共有 307 名妇女被随机分配，其中合成渗透宫颈扩张器组有 151 名可评估参与者，米索前列醇组有 152 名（有 4 名提前退出）。与米索前列醇相比，机械性宫颈扩张组在 36 小时内阴道分娩的比例更高（61.6%比 59.2%），绝对差异为 2.4%（95%CI-9%至 13%），表明符合预设边界的非劣效性。两种分娩方式无差异。米索前列醇组心动过速更常见（70[46.4%]比 35[23.3%]；P=.01）。合成渗透宫颈扩张器组的参与者报告睡眠更好、腹部不适更少、疼痛评分更低（P<.05）。
合成渗透宫颈扩张器在宫颈成熟方面不劣于口服米索前列醇。合成渗透宫颈扩张器的优点包括更好的安全性和患者满意度、心动过速发生率较低、疼痛评分较低，以及获得美国食品和药物管理局批准。
ClinicalTrials.gov，NCT03670836。
捷克共和国 Medicem Technology s.r.o.。
