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

Inclusion Criteria1

  • \- All women 18 years and older admitted to delivery at Stony Brook University hospital who agree to participate in the study

Exclusion Criteria5

  • Women under 18 years old
  • Women with known coagulation disorders
  • Women with planned cesarean hysterectomy
  • Women with known placental accreta spectrum disorders
  • Women with known allergy to prostaglandins

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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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