Misoprostol for Primary versus Secondary Prevention of Postpartum Haemorrhage: A Cluster‐Randomised Non‐Inferiority Community Trial

BJOG; 2016 Jan; 123(1):120-7; doi:10.1111/1471-0528.13540

Objective: To assess whether secondary prevention, which preemptively treats women with above-average postpartum bleeding, is non-inferior to universal prophylaxis.

Design: A cluster-randomised non-inferiority community trial.

Setting: Health sub-centres and home deliveries in the Bijapur district of Karnataka, India.

Population: Women with low-risk pregnancies who were eligible for delivery with an Auxiliary Nurse Midwife at home or sub-centre and who consented to be part of the study.

Methods: Auxiliary Nurse Midwifes were randomised to secondary prevention using 800 mcg sublingual misoprostol administered to women with postpartum blood loss ≥350 ml or to universal prophylaxis using 600 mcg oral misoprostol administered to all women during the third stage of labour.

Main outcome measures: Postpartum haemoglobin ≤7.8 g/dl, mean postpartum blood loss and postpartum haemoglobin, postpartum haemorrhage rate, transfer to higher-level facilities, acceptability and feasibility of the intervention.

Results: Misoprostol was administered to 99.7% of women as primary prevention. In secondary prevention, 92 (4.7%) women had postpartum bleeding ≥350 ml, of which 90 (97.8%) received misoprostol. The proportion of women with postpartum haemoglobin ≤7.8 g/dl was 5.9 and 8.8% in secondary and primary prevention clusters, respectively [difference −2.9%, one-sided 95% confidence interval (CI) <1.3%]. Postpartum transfer and haemorrhage rates were low (<1%) in both groups. Shivering was more common in primary prevention clusters (P = 0.013).

Conclusion: Secondary prevention of postpartum haemorrhage with misoprostol is non-inferior to universal prophylaxis based on the primary outcome of postpartum haemoglobin. Secondary prevention could be a good alternative to universal prophylaxis as it medicates fewer women and is an acceptable and feasible strategy at the community level.

Tweetable abstract: Secondary prevention of postpartum haemorrhage with misoprostol is non-inferior to universal prophylaxis.

Keywords: Misoprostol; postpartum haemorrhage; primary prevention; secondary prevention.