A randomised placebo controlled trial of oral misoprostol in the third stage of labour

Objective To compare oral misoprostol 400 mu g with placebo in the routine management of the third stage of labour. Design A double-blind placebo controlled trial. Setting The labour ward of an academic hospital in Johannesburg, South Africa with 7000 deliveries per annum. Participants Low-risk women expected to deliver vaginally. Methods Women in labour were randomly allocated to receive either misoprostol 400 mu g orally or placebo after the birth. Conventional oxytocics were given immediately if blood loss was thought to be more than usual. Postpartum blood loss in the first hour was measured by collection in a special flat plastic bedpan. Side effects were recorded. Main outcome measures Measured blood loss greater than or equal to 1000 mi within the first hour after birth. Use of additional oxytocics. Results The groups were well matched. Measured blood loss greater than or equal to 1000 mi occurred in 15/250 (6%) after misoprostol and 23/250 (9%) after placebo (relative risk 0.65; 95% confidence interval 0.35-1.22). The difference may have been reduced by the greater use of conventional oxytocics in the placebo group, which was statistically significant for intravenous oxytocin infusion(2.8% vs 8.4%, relative risk 0.33, 95% confidence interval 0.14-0.77). Shivering was more common in the misoprostol group (19% vs 5%, relative risk 3.69; 95% confidence interval 2.05-6.64). Conclusions Shivering has been shown in this study to be a specific side effect of misoprostol administered orally in the puerperium. No serious side effects were noted. Misoprostol shows promise as a method of preventing postpartum haemorrhage. Because of the potential benefits for childbearing women, particularly those in developing countries, further research to determine its effects with greater certainty should be expedited.