drugset / Trial / NCT05245227

Double Simultaneous Uterotonic Agents Versus Single Agent Regimen to Prevent Early Postpartum Hemorrhage

NCT05245227

Phase 3 Recruiting 1358 enrolled Stony Brook University
RandomizedParallel-groupOpen-labelPrevention

Summary

To determine the effectiveness of using two medications simultaneously versus one medication, as is standard of care, in preventing early postpartum hemorrhage. There have been studies that looked at giving two medications and that there were reduced odds of postpartum hemorrhage. Specific Aim 1: Determine if double simultaneous uterotonic agent regimen (misoprostol and oxytocin) is superior to single agent (oxytocin only) in reducing postpartum hemorrhage. Specific Aim 2: Determine any potential side effects of a double simultaneous uterotonic agentregimen (misoprostol and oxytocin) versus a single agent (oxytocin only).

Timeline

Start
2025-01-27
Primary completion
2027-01-01
Completion
2027-01-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Misoprostol Other / unclassified 400 ug Other
Background Oxytocin Peptide 40 iu Intravenous

Indications

No indication recorded.