Effect of sublingual misoprostol on severe postpartum haemorrhage in a primary health centre in Guinea-Bissau: Randomised double blind clinical trial

Abstract

Objective: To evaluate whether routine administration of sublingual misoprostol 600 μg 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 μg or placebo administered sublingually immediately after delivery. Main outcome measures: Postpartum haemorrhage, defined as a loss of ≥ 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 ≥ 1000 ml 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 ≥ 1000 ml (0.66, 0.45 to 0.98) 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/1 (-0.01 mmol/1 to 0.32 mmol/1). Conclusion: Sublingual misoprostol reduces the frequency of severe postpartum haemorrhage.