Administration of misoprostol by trained traditional birth attendants to prevent postpartum haemorrhage in homebirths in Pakistan: a randomised placebo-controlled trial

Objective To determine if misoprostol is safe and efficacious in preventing postpartum haemorrhage (PPH) when administered by trained traditional birth attendants (TBA) at home deliveries. Design A randomised, double-blind, placebo-controlled trial. Setting Chitral, Khyber Pakhtunkhwa Province, Pakistan. Population A total of 1119 women giving birth at home. Methods From June 2006 to June 2008, consenting women were randomised to receive 600 mu g oral misoprostol (n = 534) or placebo (n = 585) after delivery to determine whether misoprostol reduced the incidence of PPH (>= 500 ml). Main outcome measures The primary outcomes were measured blood loss >= 500 ml after delivery and drop in haemoglobin > 2 g/dl from before to after delivery. Results Oral misoprostol was associated with a significant reduction in the rate of PPH (>= 500 ml) (16.5 versus 21.9%; relative risk 0.76, 95% CI 0.59-0.97). There were no measurable differences between study groups for drop in haemoglobin > 2 g/dl (relative risk 0.79, 95% CI 0.62-1.02); but significantly fewer women receiving misoprostol had a drop in haemoglobin > 3 g/dl, compared with placebo (5.1 versus 9.6%; relative risk 0.53, 95% CI 0.34-0.83). Shivering and chills were significantly more common with misoprostol. There were no maternal deaths among participants. Conclusions Postpartum administration of 600 mu g oral misoprostol by trained TBAs at home deliveries reduces the rate of PPH by 24%. Given its ease of use and low cost, misoprostol could reduce the burden of PPH in community settings where universal oxytocin prophylaxis is not feasible. Continual training and skill-building for TBAs, along with monitoring and evaluation of programme effectiveness, should accompany any widespread introduction of this drug. Trial registration http://clinicaltrials.gov/NCT00120237 Misoprostol for the Prevention of Postpartum Hemorrhage in Rural Pakistan.