Oral misoprostol in preventing postpartum haemorrhage in resource-poor communities: a randomised controlled trial.

Abstract

BACKGROUND:

Postpartum haemorrhage is a major cause of maternal mortality in the developing world. Although effective methods for prevention and treatment of such haemorrhage exist--such as the uterotonic drug oxytocin--most are not feasible in resource-poor settings where many births occur at home. We aimed to investigate whether oral misoprostol, a potential alternative to oxytocin, could prevent postpartum haemorrhage in a community home-birth setting.

METHODS:

In a placebo-controlled trial undertaken between September, 2002, and December, 2005, 1620 women in rural India were randomised to receive oral misoprostol (n=812) or placebo (n=808) after delivery. 25 auxiliary nurse midwives undertook the deliveries, administered the study drug, and measured blood loss. The primary outcome was the incidence of acute postpartum haemorrhage (defined as > or =500 mL bleeding) within 2 h of delivery. Analysis was by intention-to-treat. The trial was registered with the US clinical trials database (http://www. clinicaltrials.gov) as number NCT00097123.

FINDINGS:

Oral misoprostol was associated with a significant reduction in the rate of acute postpartum haemorrhage (12.0% to 6.4%, p<0.0001; relative risk 0.53 [95% CI 0.39-0.74]) and acute severe postpartum haemorrhage (1.2% to 0.2%, p<0.0001; 0.20 [0.04-0.91]. One case of postpartum haemorrhage was prevented for every 18 women treated. Misoprostol was also associated with a decrease in mean postpartum blood loss (262.3 mL to 214.3 mL, p<0.0001). Postpartum haemorrhage rates fell over time in both groups but remained significantly higher in the placebo group. Women taking misoprostol had a higher rate of transitory symptoms of chills and fever than the control.

INTERPRETATION:

Oral misoprostol was associated with significant decreases in the rate of acute postpartum haemorrhage and mean blood loss. The drug's low cost, ease of administration, stability, and a positive safety profile make it a good option in resource-poor settings.

• Authors: Richard J Derman, Bhalchandra S Kodkany, Shivaprasad S Goudar, Stacie E Geller, Vijaya A Naik, M B Bellad, Shobhana S Patted, Ashlesha Patel, Stanley A Edlavitch, Tyler Hartwell, Hrishikesh Chakraborty, Nancy Moss
• Journal: Lancet (London, England) (Lancet) Vol. 368 Issue 9543 Pg. 1248-53 (Oct 07 2006) ISSN: 1474-547X [Electronic] England
• PMID: 17027730 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)

Chemical References

• Oxytocics
• Misoprostol

Topics

• Administration, Oral
• Female
• Home Childbirth
• Humans
• India
• Midwifery
• Misoprostol (administration & dosage, adverse effects, therapeutic use)
• Oxytocics (administration & dosage, adverse effects, therapeutic use)
• Postpartum Hemorrhage (prevention & control)
• Poverty Areas
• Rural Health