Principal investigator: Jun (Jim) Zhang, M.D., Ph.D.
Health care providers are increasingly using misoprostol for medical management of early pregnancy failure. However, the efficacy, safety, and acceptability of this treatment have yet to be established in a large randomized trial. To accomplish that, researchers conducted a multi-center randomized equivalence trial. A total of 652 women with a first trimester pregnancy failure (e.g., anembryonic gestation, fetal demise, incomplete and inevitable spontaneous abortion) were randomized (1:3) to receive either vacuum aspiration (VA, the current standard of care), or 800 µg vaginal misoprostol. Subjects receiving misoprostol returned on Day 3. If the expulsion was incomplete, a second dose of 800 µg vaginal misoprostol was given. On Day 8, if the expulsion was still incomplete, VA was offered. On Day 15, all subjects returned for follow-up visit. A telephone interview was conducted on Day 30. Failure was defined as VA (for the misoprostol treatment group) or reaspiration (for the VA group) for any reason within 30 days after the initial treatment. The study was powered to test whether the success rate in the misoprostol group was lower than that in the VA group by 18 percent. If the difference in success rate between the two groups did not exceed 18 percent, the treatments would be considered equivalent.

Overall, 161 and 491 women were randomized to VA or misoprostol, respectively. Demographic characteristics of the two groups were comparable. In the misoprostol group, 71 percent of women had complete expulsion by Day 3 and 85 percent by Day 8. Overall, treatment failures occurred in 3 percent of the VA group and 15 percent of the misoprostol regroup (difference = 12%, 90% Confidence Interval 9, 16%). Hemorrhage that required blood transfusion occurred in four women who received misoprostol. Two subjects (one in each group) were hospitalized due to heavy bleeding without transfusion, giving the incidence of heavy bleeding of 1.0 percent in the misoprostol group versus 0.6 percent in the VA group (p = 0.54). Two cases of clinical endometritis (0.4 percent) occurred in the misoprostol group.

When queried, 80 percent of women would choose misoprostol again and would recommend to others if needed. The acceptability was not different from that of the VA group. In conclusion, medical management with misoprostol for early pregnancy failure is efficacious, safe, and acceptable for women.
 
DESPR Collaborators

· Tonja R. Nansel, Ph.D.
 
Selected Publications

Zhang J, Gilles JM, Barnhart K, Creinin MD, Westhoff C, & Frederick MM. (2005). A comparison of medical management with misoprostol and surgical management for early pregnancy failure. New England Journal of Medicine, 353(8):761-769. [Abstract]