Randomized, double-blind, placebo-controlled trial of vaginal misoprostol for management of early pregnancy failures

Abstract

Objective: To determine whether misoprostol medical management of early pregnancy failures is more effective than expectant management.

Study design: Patients diagnosed with early pregnancy failures, closed cervix, and minimal vaginal bleeding were randomized to 800 microg of misoprostol or placebo placed vaginally. Patients were evaluated by ultrasound imaging 24 hours and 48 hours after study drug administration, with repeat administration if 24-hour imaging showed a persistent gestational sac. Treatment success was defined as expulsion of uterine contents within 48 hours. Patient follow-up occurred 2 weeks after expulsion of uterine contents.

Results: Treatment success occurred in 15 of 18 (83%) misoprostol patients and 2 of 16 (13%) placebo patients (P < .0001). Side effects were similar between groups except for vaginal bleeding, which was more common in the misoprostol group (P = .001). Patient satisfaction and pain perception were similar between groups.

Conclusion: Misoprostol appears to be highly effective for treating early pregnancy failures, with few side effects and high patient satisfaction.