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C-Section bladder flap may be unnecessary, new study suggests

NCT ID NCT07634679

Knowledge-focused Sponsor: Montefiore Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 15, 2026 · Updated 7 times

Summary

This study looks at whether making a bladder flap during a first C-section affects the formation of a scar defect (niche) in the uterus. Researchers will compare women who get a bladder flap to those who don't, using an ultrasound 6-8 weeks after delivery. The goal is to see if skipping the flap reduces scar problems that can cause symptoms or complications in later pregnancies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help doctors decide whether to use a bladder flap during C-sections to reduce scar-related complications in future pregnancies.
What could go wrong
This is an early-stage study with only 130 participants, so results may not apply to all women. The outcome is based on ultrasound findings, not long-term health effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 338 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Aug 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cesarean scar defect Cesarean scar defect (isthmocele)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Jack D. Weiler Hospital - Einstein Campus

    RECRUITING

    The Bronx, New York, 10461, United States

  • Montefiore Einstein Hospital - Wakefield Campus

    RECRUITING

    The Bronx, New York, 10466, United States