TY - JOUR
T1 - Oral misoprostol in preventing postpartum haemorrhage in resource-poor communities
T2 - a randomised controlled trial
AU - Derman, Richard J.
AU - Kodkany, Bhalchandra S.
AU - Goudar, Shivaprasad S.
AU - Geller, Stacie E.
AU - Naik, Vijaya A.
AU - Bellad, MB
AU - Patted, Shobhana S.
AU - Patel, Ashlesha
AU - Edlavitch, Stanley A.
AU - Hartwell, Tyler
AU - Chakraborty, Hrishikesh
AU - Moss, Nancy
N1 - Funding Information:
Funding for the project was provided by National Institute of Child Health and Human Development grant #1U01HD42372-01, “UIC-UMKC-JNMC Women's and Children's Research Unit” and by a grant from the Bill and Melinda Gates Foundation.
PY - 2006/10/7
Y1 - 2006/10/7
N2 - 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 ≥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.
AB - 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 ≥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.
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U2 - 10.1016/S0140-6736(06)69522-6
DO - 10.1016/S0140-6736(06)69522-6
M3 - Article
C2 - 17027730
AN - SCOPUS:33749243564
SN - 0140-6736
VL - 368
SP - 1248
EP - 1253
JO - The Lancet
JF - The Lancet
IS - 9543
ER -
