Clinical Trial

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

Recruiting Phase 3
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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).
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2022-02-16; most recent amendment 2025-04-30.
Status change: Not Yet Recruiting → Recruiting 2025-04-30
Status change: Recruiting → Not Yet Recruiting 2024-12-04
Trial Details
NCT Number NCT05245227
Lead Sponsor Stony Brook University
Conditions Postpartum Hemorrhage
Enrollment 1,358 participants
Start Date 2025-01-27
Primary Completion 2027-01-01 (estimated)
Study Completion 2027-01-01 (estimated)
Updated on ClinicalTrials.gov 2025-05-04