New method to control bleeding after childbirth
Official title: Novel Vacuum-Induced Hemorrhage Control for Postpartum Hemorrhage: a Multicenter Randomized Trial
Run by Women and Infants Hospital of Rhode Island · NCT05382403 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 44 Years |
| Sex | Women only |
| Enrollment | 424 (estimated) |
| Sponsor | Women and Infants Hospital of Rhode Island Academic / other |
| Locations | 2 sites (Kumasi, Ashanti Region and 1 other locations) |
| Status | Recruiting |
| Started | October 23, 2023 |
| Main results expected | August 31, 2026 |
| Study ends | April 30, 2027 |
| Registry record updated | December 21, 2023 |
| Trial ID | NCT05382403 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with retained placenta, coagulopathy, or those requiring immediate surgical intervention for life-threatening bleeding may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
Why it matters
Potential benefit: If successful, this approach could significantly reduce maternal mortality rates associated with postpartum hemorrhage.
How similar studies have gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Long-term outcomes after vacuum-induced tamponade for postpartum hemorrhage
This study will look at women who had postpartum hemorrhage treated with vacuum-induced tamponade at a Zurich hospital to see how they fared over time, including future pregnancies and fertility.
-
Calcium Gluconate After Birth to Reduce Blood Loss in Vaginal Delivery
This study tests whether giving calcium gluconate right after the baby is born can help reduce blood loss for people having a vaginal delivery.
-
Carbetocin Alone vs Carbetocin Plus Oxytocin After Elective Cesarean Delivery
This study tests whether giving carbetocin by itself after an elective cesarean is just as good as adding a supplemental oxytocin infusion.
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Simulation-based postpartum hemorrhage training to boost anesthesiology team performance
Senior anesthesiology residents will try a high-fidelity simulation program for postpartum hemorrhage to see if it improves how their teams perform during obstetric emergencies.
-
Carbetocin to prevent heavy bleeding after twin birth
This trial tests whether a single dose of carbetocin given after the second twin is born reduces heavy bleeding compared with standard oxytocin in people delivering twins.
-
Draining the umbilical cord after birth to lower postpartum bleeding
This trial tests whether draining blood from the cut umbilical cord right after birth lowers heavy bleeding after delivery in women having a term vaginal birth.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.