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

BMJ 2005; 331 doi: https://doi.org/10.1136/bmj.331.7519.723 (Published 29 September 2005) Cite this as: BMJ 2005;331:723
  1. Lars H⊘j, staff specialist (lars.hoj{at}dadlnet.dk)1,
  2. Placido Cardoso, researcher2,
  3. Birgitte Bruun Nielsen, staff specialist1,
  4. Lone Hvidman, consultant obstetrician1,
  5. Jens Nielsen, statistician3,
  6. Peter Aaby, professor3
  1. 1 Department of Obstetrics and Gynaecology, Aarhus University Hospital, 8200 Aarhus N, Denmark
  2. 2 Projecto de Saúde de Bandim, Apartado 861, Bissau, Guinea-Bissau
  3. 3 Bandim Health Project, Danish Epidemiology Science Centre, Statens Serum Institut, 2300 Copenhagen S, Denmark
  1. Correspondence to: L H⊘j
  • Accepted 30 August 2005

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.

Footnotes

  • Contributors LH was the principal investigator, contributed to the study design, wrote the draft manuscript, and is guarantor. BBN, LH, and PA contributed to the study design and were involved in the data interpretation and writing of the manuscript. PC supervised the execution of the study, did the data entry, and contributed to the write up. Rosa Amelia Caceres Perez taught the midwives, who were Angelina da Silva, Ermelinda Tchuda, Suzana Rodrigues, and Felismina António Gomes. JN conducted the statistical analysis and contributed to the data interpretation.

  • Funding The Danish Society of Obstetrics and Gynaecology, the Illum Foundation, and the Danish International Development Agency.

  • Competing interests None declared.

  • Ethical approval The scientific committee of the Ministry of Health in Guinea Bissau and the Danish central scientific ethical committee (No 624-02-0036).

  • Accepted 30 August 2005
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