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临床试验/NCT04073264
NCT04073264已完成不适用

Isthmocele After Two Different Sutures in Cesarean Section

Federico II University2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2019年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
300
试验地点
2
主要终点
incidence of cesarean scar defects at ultrasound 6-months follow-up

研究概览

简要总结

Cesarean delivery (CD) rates are rising globally. about 30% of women delivered by CD in 2015 only in the USA. This increasing CD rate has stimulated an interest in the potential short- and long-term morbidity of CD scars. In more than 50% of women with history of CD, a uterine scar defect, also called a "isthmocele," defined as a disruption of the myometrium in the CD uterine scar, can be observed when examined by gel instillation sonohysterography 6-12 months after the CD. Uterine scar defects detected on ultrasound have been associated with prolonged menstrual bleeding and postmenstrual spotting, as well as with an increased risk of several obstetrical complications in subsequent pregnancies, including uterine dehiscence and/or rupture, scar pregnancy and placenta previa and accreta. Another screening method associated with uterine scar rupture in women with prior CD is ultrasonographic measurement of the thickness of the lower uterine segment, as pioneered by Rozenberg et al. in 1996. A meta-analysis by Kok et al. supports the use of the residual myometrial thickness (RMT) for predicting uterine rupture during vaginal birth after cesarean. Uterine scar defects have been associated with lower RMT.

A growing body of evidence suggests that the surgical technique for uterine closure influences uterine scar healing and the RMT, but there is still no consensus about optimal uterine closure and type of suture. It is imperative to have evidence-based guidelines for each surgical step before recommending one technique over another.

The aim of our trial is to evaluate the incidence of cesarean scar defect according to type of suture at the time of cesarean

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 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women with singleton gestations
  • Between ≥37 and ≤42 gestational age
  • >18 <45 years
  • Undergoing primary or secondary elective or urgent cesarean delivery

排除标准

  • Multiple gestations
  • Preterm cesarean
  • 2 or more prior cesarean deliveries
  • Uterine malformations
  • Prior myomectomy
  • Placenta accreta/previa

结局指标

主要结局

incidence of cesarean scar defects at ultrasound 6-months follow-up

时间窗: 6-months follow-up after cesarean

次要结局

  • incidence of scar defects at hysteroscopy at 6 months follow-up(6-months follow-up after cesarean)
  • Symptoms of cesarean scar defect(6-months follow-up after cesarean)
  • RMT(6-months follow-up after cesarean)

研究者

发起方
Federico II University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gabriele Saccone

Principal investigator

Federico II University

研究点 (2)

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