24-Hour Compared With 12-Hour Mifepristone-Misoprostol Interval for Second-Trimester Abortion: A Randomized Controlled Trial.

IF 5.7 2区医学 Q1 OBSTETRICS & GYNECOLOGY

Obstetrics and gynecology Pub Date : 2024-07-01 Epub Date: 2024-05-23 DOI:10.1097/AOG.0000000000005535

Raanan Meyer, Shlomi Toussia-Cohen, Maya Shats, Omri Segal, Aya Mohr-Sasson, Shiran Peretz-Bookstein, Daphna Amitai-Komem, Ofra Sindel, Gabriel Levin, Roy Mashiach, Paul D Blumenthal

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引用次数: 0

Abstract

Objective: To compare 24-hour and 12-hour mifepristone-to-misoprostol intervals for second-trimester medication abortion.

Methods: We conducted a prospective randomized controlled trial. Participants were allocated to receive mifepristone either 24 hours or 12 hours before misoprostol administration. The primary outcome was the time from the first misoprostol administration to abortion (induction time). Secondary outcomes included the time from mifepristone to abortion (total abortion time); fetal expulsion percentages at 12, 24, and 48 hours after the first misoprostol dose; side effects proportion; and pain and satisfaction scores. A sample size of 40 per group (N=80) was planned to compare the 24- and 12-hour regimens.

Results: Eighty patients were enrolled between July 2020 and June 2023, with 40 patients per group. Baseline characteristics were comparable between groups. Median induction time was 9.5 hours (95% CI, 10.3-17.8 hours) and 12.5 hours (95% CI, 13.5-20.2 hours) in the 24- and 12-hour interval arms, respectively ( P =.028). Median total abortion time was 33.0 hours (95% CI, 34.2-41.9 hours) and 24.5 hours (95% CI, 25.7-32.4 hours) in the 24- and 12-hour interval groups, respectively ( P <.001). At 12 hours from misoprostol administration, 25 patients (62.5%) in the 24-hour arm and 18 patients (45.0%) in the 12-hour arm completed abortion ( P =.178). At 24 hours from misoprostol administration, 36 patients (90.0%) in the 24-hour arm and 30 patients (75.0%) in the 12-hour arm had complete abortion ( P =.139). The need for additional medication or surgical treatment for uterine evacuation, pain scores, side effects, and satisfaction levels were not different between groups.

Conclusion: A 24-hour mifepristone-to-misoprostol regimen for medication abortion in the second trimester provides a median 3-hour shorter induction time compared with the 12-hour interval. However, the median total abortion time was 8.5-hours longer in the 24-hour interval regimen. These findings can aid in shared decision making before medication abortion in the second trimester.

Clinical trial registration: ClinicalTrials.gov, NCT04160221.

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24小时与12小时米非司酮-米索前列醇用于第二胎流产的时间间隔比较：随机对照试验。

目的比较第二胎药物流产中米非司酮与米索前列醇的24小时间隔和12小时间隔：我们进行了一项前瞻性随机对照试验。参与者被分配在米索前列醇给药前 24 小时或 12 小时接受米非司酮。主要结果是首次使用米索前列醇到流产的时间（诱导时间）。次要结果包括从米非司酮到人工流产的时间（人工流产总时间）；首次服用米索前列醇后12、24和48小时的胎儿排出率；副作用比例；疼痛和满意度评分。计划每组 40 个样本量（N=80），以比较 24 小时和 12 小时方案：2020年7月至2023年6月期间，80名患者入组，每组40人。各组的基线特征相当。24小时和12小时间隔组的中位诱导时间分别为9.5小时（95% CI，10.3-17.8小时）和12.5小时（95% CI，13.5-20.2小时）（P=0.028）。24小时间隔组和12小时间隔组的中位总流产时间分别为33.0小时（95% CI，34.2-41.9小时）和24.5小时（95% CI，25.7-32.4小时）（PC结论：24小时米非司酮-米索前列醇药物流产方案与12小时药物流产方案相比，中位引产时间缩短了3小时。然而，24 小时间隔方案的中位总流产时间要长 8.5 小时。这些发现有助于第二孕期药物流产前的共同决策：临床试验注册：ClinicalTrials.gov，NCT04160221。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Obstetrics and gynecology 医学-妇产科学

CiteScore

11.10

自引率

4.20%

发文量

867

审稿时长

1 months

期刊介绍： "Obstetrics & Gynecology," affectionately known as "The Green Journal," is the official publication of the American College of Obstetricians and Gynecologists (ACOG). Since its inception in 1953, the journal has been dedicated to advancing the clinical practice of obstetrics and gynecology, as well as related fields. The journal's mission is to promote excellence in these areas by publishing a diverse range of articles that cover translational and clinical topics. "Obstetrics & Gynecology" provides a platform for the dissemination of evidence-based research, clinical guidelines, and expert opinions that are essential for the continuous improvement of women's health care. The journal's content is designed to inform and educate obstetricians, gynecologists, and other healthcare professionals, ensuring that they stay abreast of the latest developments and best practices in their field.