Mifepristone and sublingual misoprostol versus sublingual misoprostol alone for missed abortion: Results of a randomized placebo-controlled trial
- May 1st, 2019
- Medical Abortion
- Bracken, H., Zuberi, N., de Guevara Puerto, A.L., Mayi-Tsonga, S., Buendía Gómez, M., Irfan Ahmed, S., Minkobame, U., Perrin, R.X., Diop, A., Abbas, D., Pena, M., Winikoff, B.
Contraception; May 1, 2019; Vol. 99(5): 315-316; doi:https://doi.org/10.1016/j.contraception.2020.02.007
Introduction: Medical management of missed abortion has been demonstrated to be a safe and effective alternative to uterine aspiration. Regimens for medical management subjected to clinical trials using pretreatment with mifepristone followed by misoprostol have generally employed vaginal misoprostol. However, misoprostol-only regimens recommended by the World Health Organization also include sublingual misoprostol. We compared the efficacy and safety of pretreatment with mifepristone followed by sublingual misoprostol with the efficacy and safety of sublingual misoprostol alone for the management of missed abortion.
Results: Gestational sac expulsion at the follow-up visit with no additional surgical intervention occurred in 107/126 women (85.0%) in the mifepristone-misoprostol group and 120/ 143 women (83.9%) in the misoprostol-alone group (relative risk 1.0, 95% CI 0.9-1.1). Women assigned to mifepristone-misoprostol were significantly less likely to use the additional dose of misoprostol (26/126 women or 20.6%) than women who received misoprostol alone (50/143 women or 34.9%) (relative risk 0.6, 95% CI: 0.4-0.9). Women who received misoprostol alone were more likely to report that side effects were “bad” or “very bad” (65/142 or 45.8%) compared to women who received mifepristone-misoprostol (47/125 or 37.6%) (relative risk 0.82, 95% CI: 0.61-1.09).
Conclusions: Pretreatment with mifepristone did not significantly improve the effectiveness of sublingual misoprostol for treatment of missed abortion when women were allowed to use additional doses of misoprostol if they believed bleeding was too scanty. However, women who received mifepristone-misoprostol were significantly less likely to self-administer an additional dose of misoprostol and reported that side effects were more tolerable than women who received misoprostol alone.