Title: OC08.03: A randomised controlled trial comparing misoprostol to expectant care in early pregnancy failure
Abstract: To compare vaginal misoprostol with expectant management of early non-viable pregnancies with regard to complete evacuation of the uterine cavity within 10 days. Parallel randomised controlled, open label, trial. Randomisation was carried out by an off-site research service centre. Patients with early pregnancy failure (anembryonic or early fetal demise, Crown–rump length 7–33mm) and vaginal bleeding were recruited from the emergency ward of the department of obstetrics and gynecology, Skane University Hospital, Malmö, Sweden and randomly allocated to either expectant care or 800μg of misoprostol vaginally. Patients were evaluated clinically and by ultrasound until complete evacuation of the uterus. Follow-up visits were planned at 10, 17, 24 and 31 days. Dilatation and evacuation was performed if miscarriage was not complete ≤31 days, or earlier on patient's request, or if there was excessive bleeding. Main outcome measure: Number of patients with complete miscarriage ≤10 days. Clinical Trials NCT01033903. 94 patients were randomised to misoprostol and 95 to expectant care. After exclusion of 3 patients and withdrawal of consent by 2 patients 184 patients (n=94, n=90) were left to intention to treat analysis. After 10 days complete miscarriage was achieved in 66 % of the patients treated with misoprostol and in 43% of the patients with expectant management. 2 patients from each group underwent emergency D&E because of bleeding ≤10 days (2.1% vs. 2.2%). After 31 days of observation the rate of complete miscarriage was 86% in the misoprostol group and 61% in the expectant group. The number of D&E's on patient's request was higher in the expectantly managed group (17% vs. 3%) as was the number of patients making out of protocol visits (56% vs. 29%). Vaginal misoprostol is more effective than expectant management of early pregnancy failure with vaginal bleeding with regard to complete evacuation of the uterus.