New method to control bleeding after childbirth
Novel Vacuum-Induced Hemorrhage Control for Postpartum Hemorrhage: a Multicenter Randomized Trial
NA · Women and Infants Hospital of Rhode Island · NCT05382403
This study is testing a new device called the Jada® System to see if it can help women who are bleeding heavily after childbirth more effectively than standard treatments.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 424 (estimated) |
| Ages | 18 Years to 44 Years |
| Sex | Female |
| Sponsor | Women and Infants Hospital of Rhode Island (other) |
| Locations | 2 sites (Kumasi, Ashanti Region and 1 other locations) |
| Trial ID | NCT05382403 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness, safety, and cost-effectiveness of the Jada® System in treating postpartum hemorrhage (PPH) compared to standard care. With an estimated 14 million women experiencing PPH annually, this study will involve 424 participants and is designed as a definitive randomized control trial. The trial focuses on women who have experienced significant blood loss after delivery and have not responded to first-line treatments. By comparing the Jada® System to traditional methods, the study seeks to improve outcomes for women suffering from this serious condition.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 and older who have delivered at least 34 weeks gestation and experienced significant blood loss due to uterine atony.
Not a fit: Patients with retained placenta, coagulopathy, or those requiring immediate surgical intervention for life-threatening bleeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce maternal mortality rates associated with postpartum hemorrhage.
How similar studies have performed: While uterine balloon tamponade is a common second-line therapy, this specific approach using the Jada® System has not been extensively tested in prior studies, making it a novel intervention.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Kumasi, Ashanti Region and 1 other locations
- Komfo Anokye Teaching Hospital — Kumasi, Ashanti Region, Ghana (RECRUITING)
- Korle-bu Teaching Hospital — Accra, Greater Accra Region, Ghana (RECRUITING)
Study contacts
- Principal investigator: Methodius Tuuli, MD, MPH, MBA — Women and Infants Hospital of Rhode Island
- Study coordinator: Crystal Ware, BSN, CCRP
- Email: cware@wihri.org
- Phone: 401-274-1122
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Postpartum Hemorrhage, Maternal Death