Combating Maternal Mortality in Uganda: An Assessment of the Role of Misoprostol in Prevention of Post-Partum Hemorrhage

Phase 3 Completed 1140 enrolled Mbarara University of Science and Technology Makerere University · collab University Ghent · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Null hypothesis: 10 IU Oxytocin is better than sublingual misoprostol 600µg in management of third stage of labor Alternative hypothesis: Sublingual misoprostol 600µg is non- inferior to 10 IU oxytocin and will not be more than 6% worse \[than 10 IU oxytocin\] in management of third stage of labor

Timeline

Start: 2012-11
Primary completion: 2013-09
Completion: 2013-10

Publications

Atukunda EC, Siedner MJ, Obua C, Mugyenyi GR, Twagirumukiza M, Agaba AG. Sublingual misoprostol versus intramuscular oxytocin for prevention of postpartum hemorrhage in Uganda: a double-blind randomized non-inferiority trial. PLoS Med. 2014 Nov 4;11(11):e1001752. doi: 10.1371/journal.pmed.1001752. eCollection 2014 Nov.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Misoprostol	Other / unclassified	600 ug	Other

Indications

No indication recorded.