1. Compared to osmotic dilators alone, adjunctive mifepristone resulted in shorter overall procedure times for late second trimester pregnancy termination.
2. Blinded physicians reported improved cervical preparation among women randomized to adjunctive mifepristone compared to women on either adjunctive misoprostol or osmotic dilators alone.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Surgical abortions, or dilation and evacuations (D&Es), are considered a safe procedure. However, as gestational age increases, a larger fetus size is associated with an increased risk of complications, including cervical laceration, uterine perforation, and life-threatening hemorrhage. Adequate cervical dilation is paramount to reducing risk of complications. As such, the cervix is routinely prepped prior to surgery. Most commonly, osmotic dilators are used to dilate the cervix, which affect dilation by absorb vaginal mucus and expanding overnight to allow for a gradual and safe dilation. Adjunctive medications can also be used to ripen the cervix for dilation, including misoprostol (a prostaglandin) and mifepristone (a progesterone antagonist). Several studies have assessed the impact of these adjunctive medications but results have been inconclusive. In this study, researchers randomized women undergoing a second trimester D&E to receive osmotic dilators alone or with adjunctive misoprostol or mifepristone and assessed surgical outcomes.
Adjunctive mifepristone resulted in shorter overall procedure times for late second trimester terminations compared to osmotic dilators alone, although there was no difference in uterine evacuation time. Strengths included multi-center trial with double-blinded, randomized design including both free-standing abortion clinics and in-hospital operating rooms and stratification by gestational age. The study was not powered to detect a difference in complications, although there was a trend towards greater complications in the dilator alone arm. Future studies might employ a larger sample size to compare complication rates by cervical preparations.
In-Depth [randomized controlled trial]: Researchers randomized women undergoing dilation and evacuation to 1 of 3 cervical preparations: overnight osmotic dilators alone (n = 100), osmotic dilators plus 400 mg buccal misoprostol 3 hours preoperatively (n = 100), or osmotic dilators plus 200 mg oral mifepristone at time of dilator placement. Women were divided into two cohorts—early (16-18 6/7 weeks) and late (19-23 6/7 weeks) gestation. The primary outcome was operative time. Secondary outcomes included initial cervical dilation, side effects, physician satisfaction, complications, and total procedure time (inclusive of any complications).
Compared to women in the osmotic dilators alone group, blinded physicians reported improved cervical preparation among women in the adjunctive mifepristone group (p = 0.03). Among women undergoing early second trimester terminations, both the misoprostol and mifepristone regimens were less likely to require additional dilation. Among women undergoing late second trimester terminations, total procedure time was significantly less among women in the adjunctive misoprostol (10.35 vs. 13.39 min, p = 0.02) and adjunctive mifepristone (9.42 vs. 13.39 min, p = 0.003) groups. There was no difference in operative time between the three dilation regimens in either gestational cohort.
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