Impact of a Bladder Flap on Cesarean Scar Niche Development
Part of paid clinical trials in The Bronx, New York.
- Sponsor
- Montefiore Medical Center
- Study ID
- NCT07634679
- Status
- Not Yet Recruiting
Notify me when recruiting opens
Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.
Add your contact details and location so we can keep your interest tied to this study.
Conditions
- Cesarean Scar Defect (Isthmocele)
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Bladder flap formation — PROCEDUREParticipants in this arm will have a bladder flap completed at the time of their cesarean delivery.
Study Details
The goal of this trial is to examine if the completion or omission of a bladder flap impacts the location and formation of cesarean scar niche in women undergoing primary cesarean section. The main question it aims to answer is if omission of a bladder flap changes the prevalence of cesarean scar niche on a 6-8 week postpartum ultrasound. Researchers will compare participants that have a bladder flap made to those that have a bladder flap omitted at time of their primary cesarean delivery. Participants will have routine postpartum care and be asked to return for a 6-8 week postpartum transvaginal ultrasound.
Key Dates
- Start date
- Jun 30, 2026
- Status verified
- Jun 2026
- Primary completion
- Jun 1, 2027
- Completion
- May 1, 2032
Study Design
- Enrollment
- 130 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- No Intervention: Bladder flap omissionParticipants randomized to this arm will have the bladder flap step omitted prior to low transverse hysterotomy formation. Participants will not need to alter their postoperative or postpartum care.
- Experimental: Bladder flap formationParticipants randomized to this arm will have a bladder flap formed using standard procedure during the cesarean delivery prior to low transverse hysterotomy and delivery of the infant. As with the 'Bladder flap omission' arm, participants will not need to alter their postoperative or postpartum care.
Primary Outcome Measure
Presence of cesarean scar niche [ Time Frame: From enrollment to transvaginal ultrasound, completed approximately 6-8 weeks postpartum ]
Central Contacts
- Alyssa Yeung, MD574-329-8771
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Jack D. Weiler Hospital - Einstein Campus | The Bronx | New York | 10461 | |
| Montefiore Einstein Hospital - Wakefield Campus | The Bronx | New York | 10466 |