Impact of a Bladder Flap on Cesarean Scar Niche Development

Conditions

• Cesarean Scar Defect

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bladder flap formation — PROCEDURE
  Participants 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

First listed

Jun 9, 2026

Start date

Aug 31, 2026

Status verified

Aug 2026

Primary completion

Jul 1, 2027

Completion

Jun 1, 2032

Study Design

Enrollment

338 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

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.

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, MD
  574-329-8771
  [email protected]

Locations (2)

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