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临床试验/NCT07634679
NCT07634679招募中不适用

Impact of a Bladder Flap on Cesarean Scar Niche Development

Montefiore Medical Center4 个研究点 分布在 1 个国家目标入组 338 人开始时间: 2026年10月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
338
试验地点
4

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Bladder flap formation

Experimental

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.

干预措施: Bladder flap formation (Procedure)

Bladder flap omission

No Intervention

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.

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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