Reproductive outcome after early miscarriage: comparing vaginal misoprostol treatment with expectant management in planned secondary analysis of randomized controlled trial.

OBJECTIVE To compare the reproductive outcome after early miscarriage between women managed expectantly or treated with vaginal misoprostol. METHODS This study is a planned secondary analysis of prospectively collected data in a published randomized controlled trial comparing expectant management with vaginal single dose 800 μg misoprostol treatment of early embryonic or anembryonic miscarriage. The outcome measure is the number of women with a clinical pregnancy conceived within 14 months after complete miscarriage and the outcome of these pregnancies in terms of live birth, miscarriage, ectopic pregnancy and legal termination of pregnancy. The participants replied to a questionnaire sent by post covering their reproductive history <14 months after the index miscarriage was complete. Supplementary information and information for women who did not return their questionnaire was retrieved from medical records. RESULT Of 94 and 95 women randomized to misoprostol treatment or expectant management, respectively, 94 and 90 women were included for analysis. Information on reproductive outcome was available for 89/94 (95%) and 83/90 (92%) women, respectively. Complete miscarriage without surgical evacuation was achieved within 31 days in 85% (76/89) of the women in the misoprostol group and in 65% (54/83) in the expectantly managed group. The proportion of women treated with surgical evacuation was 32.5% (27/83) in the expectantly managed group versus 12% (11/89) in the misoprostol group. At 14 months after the index miscarriage was complete, 75% of the women in both treatment groups (67/89 and 62/83) had achieved at least one clinical pregnancy, and 40% (36/89) and 35% (29/83) had had a live-birth (mean difference 5.5%, 95% confidence interval, CI, of difference, -9.7 to 20.3). Sixty-three percent (56/89) of the women in the misoprostol group and 55% (46/83) of those in the expectantly managed group delivered a live baby after a pregnancy conceived within 14 months after the index miscarriage was complete (mean difference 7.5%, 95% CI of difference -7.9 to 22.4). CONCLUSION Women with early miscarriage can be reassured that fertility is similar after misoprostol treatment and expectant management. This article is protected by copyright. All rights reserved.