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Mifepristone vs. osmotic dilator insertion for cervical preparation prior to surgical abortion at 14-16 weeks: A randomized trial

机译:米非司酮与渗透性扩张剂的插入在14-16周手术流产前用于宫颈准备:一项随机试验

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Background: Cervical preparation is recommended before second-trimester abortion. We investigated the use of a pharmacologic method of preparation, mifepristone, as compared to osmotic dilators for surgical abortions at 14-16 weeks. Study Design: This was a randomized, parallel-group study with concealed allocation. Women were allocated to receive osmotic dilators or mifepristone 200 mg orally 24 h prior to abortion. The study population was 50 women seeking surgical abortion at 14-16 menstrual weeks in a hospital-based abortion service. The primary outcome was the length of time to perform the procedure; the study had 80% power to detect a difference of more than 3 min in procedure time. Secondary outcomes included cervical dilation, side effects and acceptability. Results: The mean abortion time for the osmotic dilator group was 8.00 min [95% confidence interval (CI) 6.75-11.47], and that for the mifepristone group was 9.87 min (95% CI 8.93-11.36). Side effects of pain were more common in the osmotic dilator group. Conclusion: Mifepristone did not increase the time for abortion by more than the prespecified margin (3 min). Women preferred mifepristone to osmotic dilators.
机译:背景:建议在妊娠中期流产前进行宫颈准备。我们调查了米非司酮的药理学方法与渗透性扩张剂在14-16周手术流产的比较。研究设计:这是一个隐藏分配的随机平行分组研究。在流产前24小时,将妇女分配为口服200 mg渗透性扩张剂或米非司酮。研究人群为50名妇女,她们在医院的人工流产服务中在月经14-16周时寻求手术流产。主要结果是执行手术的时间长度;该研究具有80%的功效,可检测出3分钟以上的手术时间差异。次要结果包括宫颈扩张,副作用和可接受性。结果:渗透扩张剂组的平均流产时间为8.00分钟[95%置信区间(CI)6.75-11.47],而米非司酮组的平均流产时间为9.87分钟(95%CI 8.93-11.36)。渗透压扩张器组中疼痛的副作用更为常见。结论:米非司酮不会使流产时间增加超过预定的限度(3分钟)。与渗透性扩张剂相比,女性更喜欢米非司酮。

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