Actively Recruiting
Novel Vacuum-Induced Hemorrhage Control for Postpartum Hemorrhage
Led by Women and Infants Hospital of Rhode Island · Updated on 2023-12-21
424
Participants Needed
2
Research Sites
183 weeks
Total Duration
On this page
Sponsors
W
Women and Infants Hospital of Rhode Island
Lead Sponsor
W
Washington University School of Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Novel Vacuum-Induced Hemorrhage Control for Postpartum Hemorrhage
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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 intrauterine pregnancy, untreated uterine rupture, unresolved uterine inversion, current cervical cancer, unknown uterine anomaly, current purulent infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Komfo Anokye Teaching Hospital
Kumasi, Ashanti Region, Ghana
Actively Recruiting
2
Korle-bu Teaching Hospital
Accra, Greater Accra Region, Ghana
Actively Recruiting
Research Team
C
Crystal Ware, BSN, CCRP
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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