ovel Vacuum-Induced Hemorrhage Control for Postpartum Hemorrhage: a Multicenter Randomized Trial
Phase 3
- Conditions
- Pregnancy and Childbirth
- Registration Number
- PACTR202204852865149
- Lead Sponsor
- Women and Infants Hospital of Rhode Island Warren Alpert Medical School at Brown University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- 424
Inclusion Criteria
1. 18 years or older
2. Delivery at 34 weeks or greater
3. Vaginal or cesarean delivery
4. Cumulative blood loss>1000ml within 24 after delivery
5. Uterine atony
6. Receipt of first-line uterotonics
7. Cervix at least 3 cm dilated at cesarean section
Exclusion Criteria
1. Patient unwilling or unable to provide informed consent
2. Retained placenta or other known cause of postpartum hemorrhage
3. Placenta accreta spectrum
4. Coagulopathy
5. ruptured uterus
6. Surgical management immediately needed for life-threatening bleeding
7. Known contraindication for Jada System: on-going intrauterine pregnancy, untreated uterine rupture, unresolved uterine inversion, current cervical cancer, unknown uterine anomaly, current purulent infection.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method