Using two medications to prevent 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
PHASE3 · Stony Brook University · NCT05245227
This study tests if giving two medications together can better prevent heavy bleeding after childbirth in women delivering at Stony Brook University Hospital.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1358 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Stony Brook University (other) |
| Locations | 1 site (Stony Brook, New York) |
| Trial ID | NCT05245227 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of administering two uterotonic agents, misoprostol and oxytocin, simultaneously compared to the standard single-agent regimen of oxytocin alone in preventing early postpartum hemorrhage. The research will involve women aged 18 and older who are admitted for delivery at Stony Brook University Hospital. The study will also assess any potential side effects associated with the dual medication approach. By comparing the outcomes of both regimens, the study seeks to provide insights into the best practices for managing postpartum hemorrhage.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 and older who are admitted for delivery at Stony Brook University Hospital.
Not a fit: Patients who may not benefit include those under 18, those with coagulation disorders, planned cesarean hysterectomy, placental accreta spectrum disorders, or allergies to prostaglandins.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of postpartum hemorrhage, improving maternal health outcomes.
How similar studies have performed: Previous studies have indicated that using two medications may reduce the odds of postpartum hemorrhage, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- All women 18 years and older admitted to delivery at Stony Brook University hospital who agree to participate in the study Exclusion Criteria: * 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
Where this trial is running
Stony Brook, New York
- Stony Brook University — Stony Brook, New York, United States (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Postpartum Hemorrhage