Status:
RECRUITING
Novel Vacuum-Induced Hemorrhage Control for Postpartum Hemorrhage
Lead Sponsor:
Women and Infants Hospital of Rhode Island
Collaborating Sponsors:
Washington University School of Medicine
University of Ghana
Conditions:
Postpartum Hemorrhage
Maternal Death
Eligibility:
FEMALE
18-44 years
Phase:
NA
Brief Summary
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.
Detailed Description
Every year, 130 million women deliver babies around the world, and an estimated 14 million (11%) experience postpartum hemorrhage (PPH), recently redefined as a cumulative blood loss of 1000 ml or mor...
Eligibility Criteria
Inclusion
- 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
- Patient unwilling or unable to provide informed consent
- Retained placenta or other known cause of postpartum hemorrhage
- Placenta accreta spectrum
- Coagulopathy
- Rupture uterus
- Surgical management immediately needed for life-threatening bleeding
- Known contraindication for Jada System; ongoing intrauterin pregnancy, untreated uterine rupture, unresolved uterine inversion, current cervical cancer, unknown uterine anomoly, current purulent infection
Key Trial Info
Start Date :
October 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2027
Estimated Enrollment :
424 Patients enrolled
Trial Details
Trial ID
NCT05382403
Start Date
October 23 2023
End Date
April 30 2027
Last Update
December 21 2023
Active Locations (2)
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1
Komfo Anokye Teaching Hospital
Kumasi, Ashanti Region, Ghana
2
Korle-bu Teaching Hospital
Accra, Greater Accra Region, Ghana