A randomised double blind trial comparing misoprostol or placebo in the management of early miscarriage.

ABSTRACT

OBJECTIVES: To study if misoprostol 400 microg, administered vaginally, increased the successful resolution of early miscarriage compared with placebo. DESIGN: Randomised, double blind placebo controlled study. SETTING: Sahlgrenska University Hospital, Göteborg, Sweden. SAMPLE One hundred and twenty-six women seeking medical attention for early miscarriage. METHOD: Women with a non-viable, first trimester miscarriage were randomised to vaginal administration of misoprostol 400 microg or placebo. MAIN OUTCOME MEASURES: Main outcome measure was the proportion of successful complete resolution of miscarriage. Secondary outcomes were incidence of infection, bleeding, gastrointestinal side effects, pain, use of analgesics and length of sick leave between groups. RESULTS: Sixty-four patients were randomised to misoprostol and 62 to placebo. Eighty-one percent in the misoprostol and 52% in the placebo group had a complete miscarriage within one week of the primary visit (RR 1.57; 95% CI 1.20-2.06). Patients in the misoprostol group reported more pain as assessed on a visual analogue scale (60.4 [31.0] vs 43.8 [37.1] mm; P < 0.007) and required analgesics more often (83%vs 61%, RR 1.35; 95% CI 1.08-1.70). There were no significant differences in the occurrence of gastrointestinal side effects, infection, reduction in haemoglobin or sick leave between the groups. CONCLUSIONS: Treatment with 400 mug misoprostol administered vaginally increased the success rate of resolvement of uncomplicated early miscarriages compared with placebo. However, women who received misoprostol experienced more pain and required more analgesics than those who did not.