A factorial-design randomized controlled trial comparing mifepristone to Dilapan and comparing buccal to vaginal misoprostol for same-day cervical preparation prior to dilation and evacuation
Abortion
Awarded 2014
Complex Family Planning Fellowship Research
Jamilah Shakir, MD
Washington Hospital Center
$70,000

Background: Dilation and evacuation is the most common method of second trimester abortion procedures. Adequate cervical preparation is required prior to second-trimester dilation and evacuation procedures to minimize the risk of uterine and cervical trauma. Studies have reported a strong preference by women for same-day dilation and evacuation procedures and for a pharmacological method (misoprostol) for cervical preparation. The use of a combination of misoprostol and Dilapan 3-4 hours prior to dilation and evacuation procedures in gestations up to 22 weeks gestational age is both safe and feasible. Misoprostol is commonly used either buccally or vaginally for cervical preparation. These two routes of administration have not been compared in terms of clinical outcomes, including side effect profiles.
Purpose: The objective of the study was to compare the effectiveness of same-day cervical preparation regimens of misoprostol-Dilapan and misoprostol alone prior to dilation and evacuation procedures before 20 weeks gestation and to compare the side-effect profiles and patient acceptability of buccal and vaginal misoprostol.
Methods: We conducted a randomized controlled factorial-design trial of women undergoing same-day dilation and evacuation procedures at 14 to 19 6/7 weeks gestation. At 4-6 hours prior to dilation and evacuation, all women received misoprostol, and were randomized to (1) Dilapan or not and (2) vaginal or buccal misoprostol. The primary outcome measure was total procedure time, including time for Dilapan (dilator) placement, comparing Dilapan-misoprostol to misoprostol alone. The primary outcomes of the randomization of buccal or vaginal misoprostol were side effects by 5-point Likert scale (0 none; 4 severe).
Results: 161 women were randomized. The average gestational age was 17 weeks and was similar between the two groups.The mean total procedure time was 14.1 and 10.8 minutes with and without dilators, respectively.
Conclusion: The study concluded that Dilapan (dilators) in addition to misoprostol does not shorten total procedure time for same-day dilation and evacuation up to 19 6/7 weeks. Additionally, no differences in side effects for misoprostol route were identified. Abortion providers may use either buccal or vaginal misoprostol with or without dilators 4-6 hours prior to same-day dilation and evacuation procedures up to 19 6/7 weeks gestation for cervical preparation.

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