drugset / Trial / NCT04044287

Misoprostol in the Prevention of Postpartum Haemorrhage

NCT04044287

Phase 3 Unknown 1496 enrolled The University of The West Indies
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Postpartum haemorrhage is a major contributor to maternal mortality in the developing world. The incidence is between 5 and 12% in Jamaica and varies depending on the route of delivery. Misoprostol is a uterotonic agent which has the potential to augment the effects of the standard parenteral oxytocic agents used as best practice in the active management of the third stage of labour, thereby reducing the risk of postpartum haemorrhage and its attendant complications. The Aim of the study is twofold: to show that this additive effect translates to a reduced postpartum haemorrhage rate and secondly to demonstrate reduced side effects of misoprostol resulting from the lower dose and the powdered sublingual administration.

Timeline

Start
2013-01-01
Primary completion
2019-12-31
Completion
2019-12-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Misoprostol Other / unclassified 200 ug Subcutaneous

Indications

No indication recorded.