338 Participants NeededMy employer runs this trial

Bladder Flap for Cesarean Scar Niche

(B-FIND Trial)

Recruiting at 1 trial location
AY
Overseen ByAlyssa Yeung, MD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Montefiore Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether skipping the "bladder flap" step during a C-section affects scar formation. The primary goal is to determine if omitting the bladder flap alters the frequency of scar appearance on an ultrasound 6-8 weeks postpartum. Participants will be divided into two groups: one with the bladder flap (a surgical technique) and one without, with both receiving regular postpartum care. Women undergoing their first C-section at specific hospitals and able to attend follow-up care at Montefiore Medical Center are ideal candidates for this trial. As an unphased trial, it offers participants the chance to contribute to research that could enhance surgical techniques for future C-sections.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the bladder flap technique is safe for cesarean sections?

Research has shown that creating a bladder flap during a cesarean section has been studied for safety and effectiveness. In one study with 1,188 participants, researchers examined the risk of bladder injury for those who had a bladder flap compared to those who did not. The results showed no significant increase in bladder injuries for those with the flap.

Some studies also suggest that skipping the bladder flap does not lead to more problems during surgery. This indicates that making a bladder flap is generally safe and does not add extra risk to the procedure.

Overall, the evidence supports that forming a bladder flap is safe for most people undergoing a cesarean section.12345

Why are researchers excited about this trial?

Researchers are excited about the trial for bladder flap formation in cesarean deliveries because it explores a new technique that could potentially improve recovery and outcomes for mothers. Unlike the standard method of omitting the bladder flap, this procedure involves creating a flap using the bladder tissue during the cesarean delivery. This could lead to better healing of the cesarean scar and reduce the risk of complications, such as niche formation, which can cause abnormal bleeding and pain. By investigating the differences between forming and omitting the bladder flap, researchers hope to identify the best approach for enhancing postoperative recovery and overall maternal health.

What evidence suggests that this trial's methods could be effective for cesarean scar niche?

This trial will compare the effects of bladder flap formation versus bladder flap omission during cesarean delivery. Research has shown that creating a bladder flap during a C-section doesn't significantly impact uterine scar development. Studies have found that omitting the bladder flap can speed up the surgery and reduce blood loss without increasing complications. Additionally, having a bladder flap doesn't prevent scar issues. Some studies suggest that other factors, such as incision technique, might play a more crucial role in scar problems. Overall, omitting the bladder flap appears to offer short-term benefits without adding risks.12367

Who Is on the Research Team?

PD

Pe'er Dar, MD

Principal Investigator

Montefiore Medical Center

Are You a Good Fit for This Trial?

This trial is for women having their first (primary) cesarean section. Participants must be able to return for a follow-up ultrasound 6-8 weeks after delivery.

Inclusion Criteria

I had my first low transverse C-section at Montefiore Weiler or Wakefield Hospital.
I am 18 years old or older.
Able to provide informed consent in English or Spanish
See 1 more

Exclusion Criteria

I need to have a hysterectomy before my postpartum follow-up.
My doctor cannot safely reach my lower uterus during delivery.
My uterine incision extended beyond the lower segment during surgery.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cesarean delivery with either bladder flap formation or omission

Immediate (during cesarean delivery)

Follow-up

Participants receive routine postpartum care and undergo a transvaginal ultrasound to assess cesarean scar niche

6-8 weeks postpartum
1 visit (in-person)

Long-term follow-up

Participants are monitored for cesarean scar defect and abnormal placentation in subsequent pregnancies

Up to 5 years following baseline pregnancy

What Are the Treatments Tested in This Trial?

Interventions

  • Bladder flap formation

Trial Overview

The study compares two surgical techniques during C-section: making a bladder flap versus not making one, to see if this affects the development of a scar niche seen on postpartum ultrasound.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Bladder flap formationExperimental Treatment1 Intervention
Group II: Bladder flap omissionActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials
468
Recruited
599,000+

Citations

Bladder flap creation during cesarean delivery. A systematic ...

Outcomes included were the presence of microscopic hematuria, intraoperative blood loss, hemoglobin and hematocrit changes after the operation, total operative ...

Impact of a Bladder Flap on Cesarean Scar Niche ...

While studies have suggested bladder flap omission in primary cesarean deliveries does not increase intraoperative complications and reduces operating time.

Impact of a Bladder Flap on Cesarean Scar Niche Development

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 ...

Cesarean section scar defect - ScienceDirect

Common complications associated with hysteroscopic remodeling include uterine rupture and bladder injury. ... The bladder flap is completed, and any remaining ...

Incidence of Uterine Cesarean Scar Niche After ...

Results: Niches were identified in 23.8% of the participants via TVS. The highest incidence was observed in women with more than two previous CSs (31.2%, 39/125) ...

Caesarean Scar Defect Incidence with Bladder Flap ...

The study will compare the incidence of niches in patients who had a cesarean section with and without the use of bladder flap dissection during their surgery.

INCIDENCE OF CESAREAN SCAR DEFECT IN CASES ...

Uterine niche is an iatrogenic pouch-like defect at the site of previous caesarean scar due to defective tissue healing. Uterine niche occurs in up to 70% ...