Abstract

Objectives The study was conducted to assess the effectiveness of mifepristone 200 mg 48 h before administering misoprostol 600 μg, sublingual vs. vaginal route, prior to dilation and evacuation (D&E) in 12- to 20-week pregnancies. Design Randomized clinical trial. Setting Clínica Mediterrania Médica, Valencia, Spain. Subjects Women with 12- to 20-week pregnancies wanting a voluntary abortion between July 9, 2004, and February 9, 2006. Methods Nine hundred women were randomized to be included in one of the following four groups: (I) mifepristone 200 mg plus sublingual misoprostol 600 μg before D&E, (II) mifepristone 200 mg plus vaginal misoprostol 600 μg before D&E, (III) sublingual misoprostol 600 μg before D&E and (IV) vaginal misoprostol 600 μg before D&E. Main Outcomes Measured The degree of cervical dilation achieved before D&E, surgical time necessary to terminate the pregnancy and side effects of misoprostol. Results The average cervical dilation in the mifepristone groups was 12.5±2.8 mm (SD) [95% confidence interval (CI), 12.3–12.8] vs. 8.5±3.2 mm (SD) (95% CI, 8.2–8.8) in those receiving only misoprostol. Surgical time in the mifepristone sublingual misoprostol group was 11.9±4.3 min (SD) vs. 13.0±5.3 min (SD) in the sublingual misoprostol group without mifepristone (p=.007); in the mifepristone vaginal misoprostol group, the average surgical time was 12.3±5.0 min (SD) vs. 13.0±6.2 (SD) in the vaginal misoprostol group without mifepristone (p=.031). Conclusions Administering mifepristone before D&E with misoprostol in second-trimester abortions makes surgery easier and shorter and, to a certain extent, lessens the risk of cervical injuries, especially in D&E in advanced gestational periods.

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