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Impact of a Bladder Flap on Cesarean Scar Niche Development

Study acronym: B-FIND
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later across 2 updates Jun 1, 2027 → Sep 1, 2027
See other at-risk trials from Montefiore Medical Center

Record History

See every version on ClinicalTrials.gov ↗

  1. Start date changed from estimate of Oct 15, 2026 to Oct 3, 2026
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 6 of 7 entries
    • Publications: details revised at 11 of 11 entries
  2. Start date: Aug 2026 to Oct 15, 2026
    • Primary completion pushed from Jul 1, 2027 to Sep 1, 2027
    • Study completion pushed from Jun 1, 2032 to Aug 1, 2032
    v4
  3. Recruitment openedv3 Show 5 more changesShow less
    • Enrollment increased: 130 → 338 participants
    • Primary completion pushed from Jun 1, 2027 to Jul 1, 2027
    • Study completion pushed from May 1, 2032 to Jun 1, 2032
    • Start date: Jul 2026 to Aug 2026
    • Site details revised at 2 of 2 sites
  4. Start date: Jun 2026 to Jul 2026v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07634679
Lead Sponsor Montefiore Medical Center
Conditions
(from sponsor)		 Cesarean Scar Defect
Enrollment 338 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov