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Not Yet Recruiting NCT07634679

Impact of a Bladder Flap on Cesarean Scar Niche Development

Conditions: Cesarean Scar Defect (Isthmocele)

Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 130
Sponsor: Montefiore Medical Center

Location: Jack D. Weiler Hospital - Einstein Campus The Bronx New York

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.

Eligibility 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07634679). StuddyBuddy aggregates publicly available trial information.