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

2026年9月10日 更新者：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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

338

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 美国
    • New York
      • The Bronx、New York、美国、10461
        • 招聘中
        • Jack D. Weiler Hospital - Einstein Campus
        • 接触：
      • The Bronx、New York、美国、10466
        • 招聘中
        • Montefiore Einstein Hospital - Wakefield Campus
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
无干预：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.
实验性的：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.
程序：Bladder flap formation
Participants in this arm will have a bladder flap completed at the time of their cesarean delivery.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Presence of cesarean scar niche
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Distance of cesarean scar niche from internal os
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Montefiore Medical Center

调查人员

  • 首席研究员：Pe'er Dar, MD、Montefiore Medical Center

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月15日

初级完成 (估计的)

2027年9月1日

研究完成 (估计的)

2032年8月1日

研究注册日期

首次提交

2026年6月4日

首先提交符合 QC 标准的

2026年6月4日

首次发布 (实际的)

2026年6月9日

研究记录更新

最后更新发布 (实际的)

2026年9月14日

上次提交的符合 QC 标准的更新

2026年9月10日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • 2025-17472
  • 2025 (美国 NIH 拨款/合同：Faculty of Social Sciences Scientific Grant at the University of Gdańsk)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

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

IPD 共享时间框架

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

IPD 共享访问标准

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

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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