Impact of bladder flap on cesarean scar niche after first cesarean
Official title: Impact of a Bladder Flap on Cesarean Scar Niche Development
Run by Montefiore Medical Center · NCT07634679 · Data updated 2026-11-12
This study tests whether omitting or keeping a bladder flap during a first cesarean affects the development of a cesarean scar niche seen about 6–8 weeks after delivery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 338 (estimated) |
| Sponsor | Montefiore Medical Center Academic / other |
| Locations | 2 sites (The Bronx, New York and 1 other locations) |
| Status | Recruiting |
| Started | October 3, 2026 |
| Main results expected | September 1, 2027 |
| Study ends | August 1, 2032 |
| Registry record updated | October 7, 2026 |
| Trial ID | NCT07634679 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18 or older undergoing a primary low-transverse cesarean at Montefiore Weiler or Wakefield Hospitals, with plan for postpartum care at Montefiore.
✕Probably not a fit
Women who do not develop a cesarean scar niche or whose outcomes are not influenced by the bladder flap technique may not experience a direct benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The trial compares two surgical approaches during primary cesarean delivery: performing a bladder flap versus omitting it. Participants are women undergoing their first cesarean with planned postpartum follow-up and ultrasound at 6–8 weeks to assess scar characteristics. It uses randomization or allocation by surgeon discretion to evaluate the effect on cesarean scar niche prevalence. Postpartum ultrasound findings will inform potential associations with future obstetric and gynecologic implications. The study sites are two Montefiore Medical Center campuses in the Bronx, with eligibility limited to English or Spanish speakers who plan postpartum care at the institution.
Why it matters
Potential benefit: If bladder flap omission or preservation reduces scar niche formation, future surgeries and follow-up care could be tailored to improve uterine healing.
How similar studies have gone: Previous work suggests bladder flap omission can reduce operative time without clear impact on intraoperative complications or CSN, but CSN assessment was not previously evaluated; this study addresses that gap.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years or older * Primary low transverse cesarean section performed at Montefiore Weiler or Wakefield Hospitals * Able to provide informed consent in English or Spanish * Plan for postpartum care at Montefiore Medical Center Exclusion Criteria: * History of a prior uterine surgery * Known congenital uterine anomalies * Inability to safely access lower uterine segment at time of delivery * Hysterotomy is extended past/outside the lower uterine segment at time of surgery * Hysterectomy is indicated prior to postpartum follow-up
Where it's running
-
Jack D. Weiler Hospital - Einstein Campus
The Bronx, New York, United States Recruiting -
Montefiore Einstein Hospital - Wakefield Campus
The Bronx, New York, United States Recruiting
Study contacts
- Principal investigator: Pe'er Dar, MD — Montefiore Medical Center
- Study coordinator: Alyssa Yeung, MD
- Email: ayeung@montefiore.org
- Phone: 574-329-8771
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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.