← Back to Search

Prostaglandin E1 Analog

Double Uterotonic Agents for Postpartum Hemorrhage

Phase 3
Recruiting
Research Sponsored by Stony Brook University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

Study Summary

This trial will compare the effects of two different medications given to prevent postpartum hemorrhage.

Who is the study for?
This trial is for women aged 18 or older giving birth at Stony Brook University hospital who consent to participate. It excludes those planning a cesarean hysterectomy, with placental accreta spectrum disorders, allergies to prostaglandins, coagulation disorders, or under 18.Check my eligibility
What is being tested?
The study tests if using two drugs (IV Oxytocin and Sublingual Misoprostol) together is better than just one (Oxytocin alone) in preventing early postpartum hemorrhage. The effectiveness and side effects of the double versus single medication regimen are being compared.See study design
What are the potential side effects?
Potential side effects may include reactions related to uterotonic agents such as nausea, vomiting, diarrhea, fever, shivering and heart rate changes. Specific side effects from combining these medications will be studied.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine if double simultaneous uterotonic agent regimen (misoprostol and oxytocin) is superior to single agent (oxytocin only) in changing postpartum hemorrhage blood loss volume.
Secondary outcome measures
Determine serious adverse outcomes of a double simultaneous uterotonic agent regimen (misoprostol and oxytocin) versus a single agent (oxytocin only) that is documented in the medical record.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Misoprostol plus intravenous OxytocinExperimental Treatment2 Interventions
Patients will receive standard postpartum Oxytocin IV per protocol and also be given Misoprostol 400 mcg sublingual
Group II: Intravenous Oxytocin onlyActive Control1 Intervention
Patients will receive standard postpartum Oxytocin IV per protocol
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Misoprostol
FDA approved

Find a Location

Who is running the clinical trial?

Stony Brook UniversityLead Sponsor
218 Previous Clinical Trials
38,672 Total Patients Enrolled

Media Library

Misoprostol (Prostaglandin E1 Analog) Clinical Trial Eligibility Overview. Trial Name: NCT05245227 — Phase 3
Postpartum Hemorrhage Research Study Groups: Intravenous Oxytocin only, Misoprostol plus intravenous Oxytocin
Postpartum Hemorrhage Clinical Trial 2023: Misoprostol Highlights & Side Effects. Trial Name: NCT05245227 — Phase 3
Misoprostol (Prostaglandin E1 Analog) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05245227 — Phase 3
~240 spots leftby Jan 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top