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

Part of paid clinical trials in Stony Brook, New York.

Sponsor
Stony Brook University
Study ID
NCT05245227
Phase
PHASE3
Status
Recruiting
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Conditions

  • Postpartum Hemorrhage

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Sublingual Misoprostol — DRUG
    Misoprostol 400 mcg sublingual
  • IV Oxytocin — DRUG
    40 units IV Oxytocin in 1000 mL normal saline

Study Details

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).

Key Dates

Start date
Jan 27, 2025
Status verified
Apr 2025
Primary completion
Jan 1, 2027
Completion
Jan 1, 2027

Study Design

Enrollment
1,358 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Intravenous Oxytocin only
    Patients will receive standard postpartum Oxytocin IV per protocol
  • Experimental: Misoprostol plus intravenous Oxytocin
    Patients will receive standard postpartum Oxytocin IV per protocol and also be given Misoprostol 400 mcg sublingual

Primary Outcome 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. [ Time Frame: through study completion, an average of 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Stony Brook UniversityStony BrookNew York11794
Erin Cassella
[email protected]
631-444-7650
James Bernasko, MD (PRINCIPAL_INVESTIGATOR)

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Stony Brook University· Stony Brook, NY

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