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

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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/l (−0.01 mmol/l to 0.32 mmol/l). Conclusion Sublingual misoprostol reduces the frequency of severe postpartum haemorrhage.