Double Simultaneous Uterotonic Agents Versus Single Agent Regimen to Prevent Early Postpartum Hemorrhage
Recruiting
Phase 3
Interventional Study
Postpartum Hemorrhage
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 1,358 (estimated)
- Sponsor
- Stony Brook University · Other
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About This Trial
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 …
Trial Locations
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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 p…
Contacts
No contact information available.