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Impact of a Bladder Flap on Cesarean Scar Niche Development (B-FIND)

2026년 9월 10일 업데이트: Montefiore Medical Center
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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

As the rate of cesarean deliveries increases globally, the importance of a cesarean scar niche (CSN) has evolved into a significant clinical concern with long term obstetric and gynecologic implications including increasing risk for placenta accreta spectrum (PAS) in future pregnancies and abnormal uterine bleeding. In fact, the main cause of PAS is placentation into uterine scars secondary to cesarean deliveries

Bladder flap formation is a standard step in cesarean deliveries and involves dissecting the bladder off the uterus to push it inferiorly to allow better access to the lower uterine segment for hysterotomy and decrease risk of bladder injury. The lower uterine segment is targeted for hysterotomy as it has been shown that the proportion of muscle tissue and the thickness of the wall of the uterus increases as one travels from the cervix to the fundus. Therefore, by making an incision in the lower uterine segment, the surgeon has less tissue to go through to deliver the fetus and disrupts less muscle to preserve uterine myometrial integrity. While studies have suggested bladder flap omission in primary cesarean deliveries does not increase intraoperative complications and reduces operating time. CSN assessment was not an outcome evaluated in these studies and the decision to omit or perform a bladder flap is at the discretion of the surgeon.

Previous studies have looked at different surgical techniques and different cervical dilations at time of cesarean delivery and the impact on niche formation and location. There has been no consensus on hysterotomy or other surgical techniques to decrease risk of CSN formation. To our knowledge, there have not been studies that have assessed postoperative CSN in relation to completion or omission of a bladder flap prior to hysterotomy. As such, the investigator team hypothesizes that omission of a bladder flap lends itself to a more cephalad hysterotomy and potentially more clinically significant CSNs.

연구 유형

중재적

등록 (추정된)

338

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 미국
    • New York
      • The Bronx, New York, 미국, 10461
        • 모병
        • Jack D. Weiler Hospital - Einstein Campus
        • 연락하다:
      • The Bronx, New York, 미국, 10466
        • 모병
        • Montefiore Einstein Hospital - Wakefield Campus
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
간섭 없음: 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.
실험적: 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.
절차: Bladder flap formation
Participants in this arm will have a bladder flap completed at the time of their cesarean delivery.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Presence of cesarean scar niche
기간: From enrollment to transvaginal ultrasound, completed approximately 6-8 weeks postpartum
A dichotomous measure of the presence or absence of a cesarean scar niche, as defined by a residual myometrial thickness of <3mm at the scar level, detected on transvaginal ultrasound. The presence of a cesarean scar niche increases risk for gynecologic complaints and abnormal placentation in subsequent pregnancies.
From enrollment to transvaginal ultrasound, completed approximately 6-8 weeks postpartum

2차 결과 측정

결과 측정
측정값 설명
기간
Distance of cesarean scar niche from internal os
기간: From enrollment to time of transvaginal ultrasound, completed approximately 6-8 weeks postpartum
Sonographic distance of cesarean scar niche from internal cervical os, measured in millimeters, on postpartum transvaginal ultrasound. The investigator team hypothesizes that a scar further from the internal os has increased risk for abnormal placentation in future pregnancies.
From enrollment to time of transvaginal ultrasound, completed approximately 6-8 weeks postpartum
Size of cesarean scar niche
기간: From enrollment to time of transvaginal ultrasound, completed approximately 6-8 weeks postpartum
Sonographic dimensions of length and width of cesarean scar niche, measured in mm, on transvaginal ultrasound. The investigator team hypothesizes that larger niches are associated with increased risk of abnormal placentation in future pregnancies and increased risk of future gynecologic complaints.
From enrollment to time of transvaginal ultrasound, completed approximately 6-8 weeks postpartum
Measurement of residual myometrium
기간: From enrollment to time of transvaginal ultrasound, completed approximately 6-8 weeks postpartum
Sonographic measurement of residual myometrium in mm by transvaginal ultrasound. Thinner residual myometrium may imply a larger defect, increased risk for abnormal placentation or formation of a uterine window in future pregnancies.
From enrollment to time of transvaginal ultrasound, completed approximately 6-8 weeks postpartum
Size of cesarean scar defect in subsequent pregnancy
기간: From time of enrollment to time of subsequent pregnancy, up to 5 years following baseline pregnancy
Sonographic measurement of dimensions (length and width) of cesarean scar defect in subsequent pregnancy, measured in mm, to assess if larger postpartum niches are associated with larger defects in subsequent pregnancies as they may carry increased risk of morbidity in the pregnancy.
From time of enrollment to time of subsequent pregnancy, up to 5 years following baseline pregnancy
Cases of abnormal placentation in subsequent pregnancies
기간: From time of enrollment to time of subsequent pregnancy, up to 5 years following baseline pregnancy
If encountered in a subsequent pregnancy, the number of cases of abnormal placentation in the cesarean scar and placenta accreta spectrum will be summarized. Ultrasound evidence of placenta accreta spectrum include disappearance of the border between placenta and myometrium, placental lacunae, increased vasculature from placenta extending into myometrium, abnormal invasion of placenta into surrounding organs and structures. Pathology will be used to confirm the number of cases of placenta accreta spectrum.
From time of enrollment to time of subsequent pregnancy, up to 5 years following baseline pregnancy
Uterine Position/Flexion
기간: From enrollment to time of transvaginal ultrasound, completed approximately 6-8 weeks postpartum
As an anteverted and retroflexed uterus is commonly the result of a cesarean delivery and scar tissue altering anatomical position, the clinicians will observe if a bladder flap alters position of the uterus. At the 6 week transvaginal ultrasound, the position of the uterus as anteverted or retroverted and flexion as anteflexed or retroflexed will be recorded. In the sagittal plane on transvaginal ultrasound, if the cervix appears on the viewer's right or left, the position is anteverted or retroverted, respectively. The anterior or posterior flexion of the fundus will define anteflexion and retroflexion, respectively
From enrollment to time of transvaginal ultrasound, completed approximately 6-8 weeks postpartum
Number/percentage of Operative and Postoperative Complications
기간: From enrollment to time of transvaginal ultrasound, completed approximately 6-8 weeks postpartum
Patient charts will be reviewed to summarize the number/percentage of surgical complications in each arm. This includes complications such as damage to surrounding structures, hemorrhage, hematoma formation, surgical site infections.
From enrollment to time of transvaginal ultrasound, completed approximately 6-8 weeks postpartum

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Montefiore Medical Center

수사관

  • 수석 연구원: Pe'er Dar, MD, Montefiore Medical Center

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 10월 15일

기본 완료 (추정된)

2027년 9월 1일

연구 완료 (추정된)

2032년 8월 1일

연구 등록 날짜

최초 제출

2026년 6월 4일

QC 기준을 충족하는 최초 제출

2026년 6월 4일

처음 게시됨 (실제)

2026년 6월 9일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 14일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 10일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

기타 연구 ID 번호

  • 2025-17472
  • 2025 (미국 NIH 보조금/계약: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

De-identified individual participant data (IPD) that underlie the results reported in future publications will be made available to qualified researchers upon request

IPD 공유 기간

Beginning 6 months after trial publication for a period of up to 5 years.

IPD 공유 액세스 기준

Requests will require a data use agreement and a proposal review by the study team.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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