RecruitingPhase 3NCT05245227

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

A Randomized Controlled Trial of Double Simultaneous Uterotonic Agents (Misoprostol Plus Intravenous Oxytocin) Versus Single Agent Regimen (Intravenous Oxytocin Only) to Prevent Early Postpartum Hemorrhage


Sponsor

Stony Brook University

Enrollment

1,358 participants

Start Date

Jan 27, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called IV Oxytocin and a drug called Sublingual Misoprostol for people with postpartum hemorrhage. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSublingual Misoprostol

Misoprostol 400 mcg sublingual

DRUGIV Oxytocin

40 units IV Oxytocin in 1000 mL normal saline


Locations(1)

Stony Brook University

Stony Brook, New York, United States

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NCT05245227


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