Objective: To evaluate whether routine administration of sublingual misoprostol 600 microg after delivery reduces postpartum haemorrhage.
Design: Randomised double blind placebo controlled trial.
Setting: Primary health centre in Bissau, Guinea-Bissau, West Africa.
Participants: 661 women undergoing vaginal delivery.
Intervention: Misoprostol 600 mug or placebo administered sublingually immediately after delivery.
Main outcome measures: Postpartum haemorrhage, defined as a loss of > or = 500 ml and decrease in haemoglobin concentration after delivery.
Results: The incidence of postpartum haemorrhage was not significantly different between the two groups, the relative risk being 0.89 (95% confidence interval 0.76 to 1.04) in the misoprostol group compared with the placebo group. Mean blood loss was 10.5% (-0.5% to 20.4%) lower in the misoprostol group than in the control group. Severe postpartum haemorrhage of > or = 1000 ml or > or = 1500 ml occurred in 17% (56) and 8% (25) in the placebo group and 11% (37) and 2% (7) in the misoprostol group. Significantly fewer women in the misoprostol group experienced a loss of > or = 1000 ml (0.66, 0.45 to 0.98) or > or = 1500 ml (0.28, 0.12 to 0.64). The decrease in haemoglobin concentration tended to be less in the misoprostol group, the mean difference between the two groups being 0.16 mmol/l (-0.01 mmol/l to 0.32 mmol/l).
Conclusion: Sublingual misoprostol reduces the frequency of severe postpartum haemorrhage.