NCT05245227 Double Simultaneous Uterotonic Agents Versus Single Agent Regimen to Prevent Early Postpartum Hemorrhage
| NCT ID | NCT05245227 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Stony Brook University |
| Condition | Postpartum Hemorrhage |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,358 participants |
| Start Date | 2025-01-27 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,358 participants in total. It began in 2025-01-27 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility 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
Frequently Asked Questions
Who can join the NCT05245227 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Postpartum Hemorrhage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05245227 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,358 participants.
Is NCT05245227 currently recruiting?
Yes, NCT05245227 is actively recruiting participants. Visit ClinicalTrials.gov or contact Stony Brook University to inquire about joining.
Where is the NCT05245227 trial being conducted?
This trial is being conducted at Stony Brook, United States.
Who is sponsoring the NCT05245227 clinical trial?
NCT05245227 is sponsored by Stony Brook University. The trial plans to enroll 1,358 participants.