drugset / Trial / NCT01733329

Buccal Misoprostol During Cesarean Section for Preventing Postpartum Hemorrhage

NCT01733329 ↗

Phase 4 Completed 123 enrolled Hospital Universitario Dr. Jose E. Gonzalez
RandomizedParallel-groupDouble-blindPrevention

Summary

Objective: to demonstrate that buccal misoprostol administration during cesarean delivery in women with risk factors for uterine atony decreases the need for additional uterotonic medications, uterine atony and postpartum hemorrhage. Design: randomized, double-blinded, placebo-controlled trial.

Timeline

Start
2008-02
Primary completion
2013-12
Completion
2013-12

Outcome

Met primary endpoint

registry Misoprostol vs Folic Acid; p <0.01; Fisher Exact NCT01733329 ↗

paper 24 (40%) women in the placebo group versus 6 (10%) women in the misoprostol group PMID 26534874 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Misoprostol Other / unclassified 400 ug Other

Indications

No indication recorded.