A randomized trial of oral and vaginal misoprostol to manage delivery in cases of fetal death.

OBJECTIVE: To compare the effectiveness and side effects of oral and vaginal misoprostol for the termination of second and third trimester pregnancy with intrauterine fetal death.
METHODS: Eighty pregnant women at 16-41 weeks' gestation with intrauterine fetal death were randomized in two groups to receive either 400 micro g of misoprostol orally every 4 hours (n = 40) or 200 micro g of misoprostol vaginally every 12 hours (n = 40) until the termination of pregnancy was completed. The adverse effects, progress, and outcomes of delivery were assessed.
RESULTS: The groups were similar in age, weight, height, gestational age, parity, and modified Bishop scores before intervention. The mean induction-to-delivery time in the oral group (13.95 [standard deviation (SD) = 5.63] hours) was significantly shorter than the time in the vaginal group (18.87 [SD = 10.38] hours, P =.001). The number of deliveries within 24 hours after the initial drug administration in the oral group (92.5%) was significantly higher than the number in the vaginal group (67.5%, P <.001), and all delivered within 48 hours after the initial drug administration. However, the gastrointestinal side effects in the oral group was significantly higher than in the vaginal group (P =.005).
CONCLUSION: Misoprostol (400 micro g given orally every 4 hours) was more effective than misoprostol (200 micro g given vaginally every 12 hours) for the termination of second and third trimester pregnancy with intrauterine fetal death, but with more gastrointestinal side effects.

RCT Entities:   Population Interventions Outcomes