Novel Vacuum-Induced Hemorrhage Control for Postpartum Hemorrhage
Recruiting
N/A
Interventional Study
Postpartum Hemorrhage
Maternal Death
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 44
- Sex
- Female
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 424 (estimated)
- Sponsor
- Women and Infants Hospital of Rhode Island · Other
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About This Trial
This will be the first, definitive, randomized control trial (N=424) to test the hypothesis that the Jada® System is effective, safe and cost-effective in treating PPH, compared to standard care.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 18 years or older
* Delivery at 34 weeks or greater
* Cumulative blood loss \>1000ml within 24 hours after delivery
* Uterine atony
* Receipt of first-line uterotonics
* Cervix at least 3cm dilated at cesarean section
Exclusion Criteria:
* Patient unwilling or unable to prov…
Contacts