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临床试验/NCT03915847
NCT03915847已完成不适用

Evaluation of Cesarean Scar After Three Different Uterine Closure Technis: A Randomised Trial

Ataturk University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2019年4月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
Residual myometrial thickness

研究概览

简要总结

The study compares three techniques of uterine closure on myometrium thickness at the site of uterine scar of women who underwent repeated cesarean section. Cesarean scar will be evaluated 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 closure

Active Comparator

干预措施: Single layer closure (Procedure)

Double layer closure

Active Comparator

干预措施: Double layer closure (Procedure)

Doble layer closure with trimming

Active Comparator

干预措施: Doble layer closure with trimming (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

  • Depth of defect (niche)(6 months after cesarean)
  • Operation time(10 minute after cesarean completed)
  • Length of hospitalization(One month after cesarean)
  • Change in hemoglobin(48 hours after cesarean)
  • Existence of cesarean scar defect(6 months after cesarean)
  • Width of defect(6 months after cesarean)
  • Blood product transfusion(One week after cesarean)
  • Maternal infectious morbidity(Six weeks after cesarean)

研究者

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

Ragıp Atakan Al

Proffesor in dept. of obstetrics and gynecology

Ataturk University

研究点 (1)

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