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Clinical Trial
. 2005 Oct 1;331(7519):723.
doi: 10.1136/bmj.331.7519.723.

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

Affiliations
Clinical Trial

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

Lars Høj et al. BMJ. .

Abstract

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.

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Figures

Fig 1
Fig 1
Distribution of postpartum blood loss in women according to treatment
Fig 2
Fig 2
Distribution of decrease in haemoglobin concentration after delivery in women according to treatment
Fig 3
Fig 3
Flow of participants in placebo controlled trial of misoprostol for prevention of postpartum haemorrhage

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