Medical abortion with mifepristone + misoprostol at 13 – 22 weeks: how long between the mifepristone and the misoprostol?
Dina Abbas1, Nguyen thi Nhu Ngoc2, Jennifer Blum1, Nguyen thi Bach Nga3, Huynh Kim Chi4, Roxanne Martin1, Beverly Winikoff1 1Gynuity Health Projects, New York, NY, United States Minor Outlying Islands, 2Center for Research and Collaboration in Reproductive Health, Ho Chi Minh City, Viet Nam, 3Hung Vuong Hospital, Ho Chi Minh City, Viet Nam, 4Huynh Kim Chi, Binh Duong Hospital in Obstetrics and Newborn, Binh duong Province, Viet Nam - firstname.lastname@example.org
Objective: To compare a regimen that initiates misoprostol dosing at the same time as mifepristone to a regimen where misoprostol is started 24 hours after mifepristone for termination of pregnancy of 13 – 22 weeks. Method: Double blinded randomized placebo controlled trial where participants received mifepristone either 24 hours before, or at the same time as, misoprostol (repeat doses of 400 mcg buccal every three hours). If abortion was not completed within 48 hours after induction with misoprostol the participant received standard care. Results: 504 women were enrolled in Vietnam. 87.1% of women who received the two drugs simultaneously experienced complete uterine evacuation within 24 hours after induction with misoprostol, compared to 95.1% of women who received misoprostol 24 hours after mifepristone. At 48 hours, this increased to 96% in both study arms. The mean misoprostol treatment duration and total misoprostol doses received was significantly lower in the group that received the misoprostol 24 hours later 9.13 vs. 14.66 (p=.000) and 3.47 vs. 5.44 (p=.000) respectively. Mean duration of the process, defined as receipt of mifepristone to complete abortion, was significantly shorter for women who received the drugs simultaneously 14.66 vs. 33.37 (p< 0.0001). In both groups the side effect profile was similar and overall satisfaction was high (>98%). Results will be presented by gestational age group (13 – 16; 17 – 22 weeks). Conclusion: Preliminary findings suggest that taking mifepristone and misoprostol simultaneously significantly lowers clinical efficacy at 24 hours; results in a longer mean misoprostol treatment duration; and requires more misoprostol doses. However there may be trade-offs as the simultaneous regimen significantly shortens the total time of the overall process and may require fewer clinic visits in some settings. The study provides evidence that allows providers and women to choose among two viable second trimester medical abortion regimens.