Objective To pilot a study of self-administered misoprostol after home delivery for postpartum haemorrhage (PPH) prevention.
Design A pilot placebo-controlled, double-blind randomised trial
Participants Pregnant women at least 34 weeks of gestation living in Mbale district Uganda were recruited at four health facilities. High-risk women and women planning to deliver in facilities were included.
Intervention Pregnant women attending the clinics over a 2-month period were randomised to receive either misoprostol (600 µg) or identical placebo to be self-administered orally only if they did not reach a facility for delivery. Each woman was trained on medication use and the importance of PPH. After delivery, the women were visited at home and outcome and safety data collected.
Results 748 women were randomised to either 600 µg misoprostol (n = 374) or placebo (n = 374). 93% of women were followed up and 80% of drug packets (both used and unused) were retrieved. 56.7% of women took the study medication. Medication was taken before delivery in 2 women (both in the misoprostol group) and no harm was reported. The primary outcome (fall in Hb >20%) occurred in 7.3% of recruits. There were no significant differences between the groups in the rate of postnatal anaemia or self-reported blood loss. There was significantly more self-reported fever and shivering in the misoprostol group but acceptability of side effects was high.
Conclusion A randomised trial of self-administered misoprostol is feasible, and the pilot did not reveal major safety concerns with advanced distribution of misoprostol for self-administration.
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