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 μg 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 μg 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 Misoprostol for the Prevention of Postpartum Hemorrhage in Rural Pakistan.