NCT05382403 Novel Vacuum-Induced Hemorrhage Control for Postpartum Hemorrhage
| NCT ID | NCT05382403 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Women and Infants Hospital of Rhode Island |
| Condition | Postpartum Hemorrhage |
| Study Type | INTERVENTIONAL |
| Enrollment | 424 participants |
| Start Date | 2023-10-23 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 424 participants in total. It began in 2023-10-23 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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 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
Contact & Investigator
Methodius Tuuli, MD, MPH, MBA
PRINCIPAL INVESTIGATOR
Women and Infants Hospital of Rhode Island
Frequently Asked Questions
Who can join the NCT05382403 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 44 Years, studying Postpartum Hemorrhage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05382403 currently recruiting?
Yes, NCT05382403 is actively recruiting participants. Contact the research team at cware@wihri.org for enrollment information.
Where is the NCT05382403 trial being conducted?
This trial is being conducted at Kumasi, Ghana, Accra, Ghana.
Who is sponsoring the NCT05382403 clinical trial?
NCT05382403 is sponsored by Women and Infants Hospital of Rhode Island. The principal investigator is Methodius Tuuli, MD, MPH, MBA at Women and Infants Hospital of Rhode Island. The trial plans to enroll 424 participants.