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临床试验/NCT03644433
NCT03644433Unknown不适用

Impact of Single Layer Versus Double Layer Uterine Closure on the Cesarean Scar Healing

Ataturk University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2018年8月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
70
试验地点
1
主要终点
residual myometrial thickness

研究概览

简要总结

We compares two techniques of uterine closure on myometrium thickness at the site of uterine scar of women who underwent repeated cesarean section. We will evaluate myometrial thickness by transvaginal ultrasound six months after cesarean.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •previous two or three cesarean
  • •gestational weeks >=36 weeks

排除标准

  • •risk of obstetric haemorrhage
  • •suspicion or diagnosis placenta previa or accrete syndrome
  • •chorioamnionitis
  • •uterine myoma in the anterior uterine segment
  • •hysterotomy other than lower segment uterine incision at previous cesarean

研究组 & 干预措施

Single layer

Placebo Comparator

Single layer closure

干预措施: Single layer closure (Procedure)

Double layer with resection

Active Comparator

Double layer closure after resection uterine scar

干预措施: Double layer closure after resection uterine scar (Procedure)

结局指标

主要结局

residual myometrial thickness

时间窗: 6 months after cesarean

Myometrial thickness at the uterine scar by transvaginal ultrasound

次要结局

  • Existence of cesarean scar defect(6 weeks after cesarean)
  • Operation time(10 minute after cesarean completed)
  • Maternal infectious morbidity(six weeks after cesarean)
  • residual myometrial thickness(6 weeks after cesarean)
  • Healing ratio(6 weeks after cesarean)
  • Change in hemoglobin(48 hours after cesarean)
  • Blood product transfusion(One week after cesarean)
  • Length of hospitalization(One month after cesarean)
  • Healing ratio(6 months after cesarean)
  • Existence of cesarean scar defect(6 months after cesarean)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ragıp Atakan Al

Professor in obstetrics And gynecology

Ataturk University

研究点 (1)

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