Recruiting

Bladder Flap

Sponsor:

Montefiore Medical Center

Code:

NCT07634679

Conditions

Cesarean Scar Defect

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bladder flap formation

Study Details

Brief summary:

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.

Conditions

Cesarean Scar Defect

Study ID

NCT07634679

Start date

Oct 3, 2026

Status verified date

Oct, 2026

Completion date

Aug 1, 2032

Anticipated

Primary completion date

Sep 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

338 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Bladder flap omission

Participants 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 formation

Participants 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.

Interventions

Bladder flap formation

Participants in this arm will have a bladder flap completed at the time of their cesarean delivery.

Primary outcome measure

  • Presence of cesarean scar niche [ Time Frame: From enrollment to transvaginal ultrasound, completed approximately 6-8 weeks postpartum ]

Central Contacts and Locations

Central contacts

Alyssa Yeung, MD

574-329-8771ayeung@montefiore.org

Locations

Jack D. Weiler Hospital - Einstein Campus

Recruiting

The Bronx, New York, United States, 10461

Contacts

Alyssa Yeung, MD

574-329-8771ayeung@montefiore.org

Montefiore Einstein Hospital - Wakefield Campus

Recruiting

The Bronx, New York, United States, 10466

Contacts

Alyssa Yeung, MD

574-329-8771ayeung@montefiore.org

More Information

Sponsor

Montefiore Medical Center

Last update posted

Oct 7, 2026

Last verified

Oct, 2026

Keywords

  • Isthmocele

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Montefiore Medical Center on 2026-10-07. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.