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Oxytocin

Pitocin, Syntocinon

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Studies 93
Trials 100
Recruiting PHASE3 INTERVENTIONAL NCT05245227

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

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief 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).

Detailed Description

Postpartum hemorrhage (PPH) is the leading cause of maternal morbidity and mortality in the world, accounting for a quarter of all maternal deaths globally. Most cases of PPH can be attributed to uterine atony, failure of the uterus to contract in the immediate postpartum period. Efforts to prevent uterine atony and thereby PPH have focused on active clinical management of the third stage of labor (the period between delivery of the infant and placenta) and the administration of uterotonic agents (medication that induces uterine contraction). Universal standard of care to prevent postpartum hemorrhage, according to the American College of Obstetrics and Gynecologists and World Health Organization includes various dose infusions of oxytocin. Additional uterotonics are given if necessary, according to noted blood loss and uterine tone. The best uterotonic(s), combination, route, and dose, however, remain actively debated. Randomized controlled trials have not proven that misoprostol is superior to oxytocin or methergine to treat postpartum hemorrhage, but it is a medication that is often used conjunctively or after other agents fail. A Cochrane review of treatment of primary postpartum hemorrhage revealed that oxytocin, ergot alkaloids (i.e., methergine), and combined oxytocin-ergot alkaloid administration were equally effective in preventing PPH in the general obstetric population, whereas prostaglandins alone (i.e., misoprostol) were not. In an effort to determine the benefit of a simultaneous double uterotonic agent regimen in the prevention of PPH, the investigators propose to conduct a controlled trial in which women will be randomly assigned to an intervention group (buccal misoprostol and intravenous oxytocin administered simultaneously) versus a control group (standard of care, intravenous oxytocin alone).

Interventions

Name: Sublingual Misoprostol
Type: DRUG
Description: Misoprostol 400 mcg sublingual
Name: IV Oxytocin
Type: DRUG
Description: 40 units IV Oxytocin in 1000 mL normal saline

Primary Outcomes

Measure: Determine if double simultaneous uterotonic agent regimen (misoprostol and oxytocin) is superior to single agent (oxytocin only) in changing postpartum hemorrhage blood loss volume.
TimeFrame: through study completion, an average of 1 year
Description: Determine if double simultaneous uterotonic agent regimen (misoprostol and oxytocin) is superior to single agent (oxytocin only) in changing postpartum hemorrhage.

Trial Information

NCT ID

NCT05245227

Status

Recruiting

Study Type

INTERVENTIONAL

Phases

PHASE3

Sponsor

Stony Brook University

Last Updated

December 15, 2025