Objective: To explore the clinical and programmatic feasibility of using 800 μg of sublingual misoprostol to prevent and treat postpartum hemorrhage (PPH) during home delivery.
Methods: The present double-blind randomized controlled trial included women who underwent home deliveries in Chitral district, Khyber Pakhtunkhwa province, Pakistan, after presenting at healthcare facilities during the third trimester of pregnancy between May 28, 2012, and November 27, 2014. Participants were randomized in a 1:1 ratio to receive either 800 μg of misoprostol or placebo sublingually if PPH was diagnosed, having previously received a prophylactic oral dose of 600 μg misoprostol. The primary outcome, hemoglobin decrease of 20 g/L or greater from pre- to post-delivery assessment, was compared on a modified intention-to-treat basis.
Results: There were 49 patients allocated to receive misoprostol and 38 allocated to receive placebo; the incidence of a 20 g/L decrease in hemoglobin was similar between the groups (20/43 [47%] vs 19/33 [58%], respectively; P=0.335).
Conclusion: There was no significant difference in clinical outcomes between the two trial arms. ClinicalTrials.gov:NCT01485562.
Keywords: Home delivery; Misoprostol; Postpartum hemorrhage; Prophylaxis; Traditional birth attendant; Treatment.
© 2018 International Federation of Gynecology and Obstetrics.