Novel Vacuum-Induced Hemorrhage Control for Postpartum Hemorrhage
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-44
SponsorWomen and Infants Hospital of Rhode Island
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.
Eligibility criteria
Qualifiers
18 years or older
Delivery at 34 weeks or greater
Cumulative blood loss >1000ml within 24 hours after delivery
Uterine atony
Disqualifiers
Patient unwilling or unable to provide informed consent
Retained placenta or other known cause of postpartum hemorrhage
Placenta accreta spectrum
Coagulopathy
Trial design
Treatments tested in this trial
- Jada® System
- Standard care
Treatment groups
424 Participants
are divided into 2 treatment groupsSponsors and collaborators
Women and Infants Hospital of Rhode Island
Lead sponsor
Washington University School of Medicine
Collaborator
University of Ghana
Collaborator
Kwame Nkrumah University of Science and Technology
Collaborator
Source ClinicalTrials.gov