Paris Amy E, Vragovic Olivera, Sonalkar Sarita, Finneseth Molly, Borgatta Lynn
Obstetrics and Gynecology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA
Dartmouth College Geisel School of Medicine, Hanover, New Hampshire, USA.
BMJ Sex Reprod Health. 2019 Nov 21. doi: 10.1136/bmjsrh-2019-200367.
Cervical preparation is recommended prior to second-trimester surgical abortion. Osmotic dilators are an effective means to prepare the cervix, but require an additional procedure and may cause discomfort. We compared cervical preparation with mifepristone and misoprostol to preparation with osmotic dilators.
A randomised, controlled, non-inferiority trial was performed to compare cervical preparation with mifepristone and misoprostol to preparation with osmotic dilators in women undergoing surgical abortion between 15 and 18 weeks gestation. The medication group (n=29) received mifepristone 200 mg orally 24 hours prior to uterine evacuation and misoprostol 400 μg buccally 2 hours before the procedure. The dilator group (n=20) underwent osmotic dilator insertion 24 hours prior to the procedure. The primary outcome was total procedure time, from insertion to removal of the speculum. Secondary outcomes included operative time (from intrauterine instrumentation to speculum removal), initial cervical dilation, nausea, pain, ease of procedure, and whether participants would choose the same modality in the future.
For mean total procedure time, medication preparation (14.0 min, 95% CI 12.0-16.1) was not inferior to dilators (14.3 min, 95% CI 11.7 to 16.8, p<0.001). Mean operative time and ease of procedure were also similar between groups. More women in the medication group than the dilator group would prefer to use the same method in the future (86% vs 30%, p=0.003).
Prior to surgical abortion at 15-18 weeks, use of mifepristone and misoprostol did not result in longer procedure times than overnight osmotic dilators.
NCT01462.
建议在孕中期手术流产前进行宫颈准备。渗透扩张器是准备宫颈的有效方法，但需要额外的操作且可能会引起不适。我们比较了米非司酮和米索前列醇进行宫颈准备与渗透扩张器进行宫颈准备的效果。
进行了一项随机对照非劣效性试验，以比较在妊娠15至18周接受手术流产的女性中，米非司酮和米索前列醇进行宫颈准备与渗透扩张器进行宫颈准备的效果。药物组（n = 29）在清宫术前24小时口服200毫克米非司酮，术前2小时口腔含服400微克米索前列醇。扩张器组（n = 20）在手术前24小时插入渗透扩张器。主要结局是从插入窥器到取出窥器的总手术时间。次要结局包括手术时间（从子宫内器械操作到取出窥器）、初始宫颈扩张、恶心、疼痛、手术难易程度以及参与者未来是否会选择相同的方式。
对于平均总手术时间，药物准备组（14.0分钟，95%可信区间12.0 - 16.1）不劣于扩张器组（14.3分钟，95%可信区间11.7至16.8，p<0.001）。两组之间的平均手术时间和手术难易程度也相似。药物组中比扩张器组更多的女性未来更愿意使用相同的方法（86%对30%，p = 0.003）。
在15 - 18周手术流产前，使用米非司酮和米索前列醇的手术时间并不比过夜使用渗透扩张器的时间长。
NCT01462
