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临床试验/NCT01860859
NCT01860859已完成不适用

Randomized Controlled Trial Comparing Three Techniques of Uterine Closure on the Myometrium Thickness Evaluated With Ultrasound Six Months After a Primary Cesarean

CHU de Quebec-Universite Laval2 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2013年3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
81
试验地点
2
主要终点
Mean myometrium thickness

研究概览

简要总结

This study compares three techniques of uterine closure on myometrium thickness evaluated by ultrasound six months after the primary cesarean. The three techniques include: 1) locked single layer closure; 2) double layer closure with a first continuous locked suture and a second imbricating continuous suture; 3) double layer closure with a first continuous unlocked suture of the deep portion of the myometrium avoiding the inclusion of the decidua and a second unlocked continuous suture that approximate the upper portion of the myometrium. The primary outcome is the mean myometrium thickness at the site of the uterine scar evaluated by transvaginal ultrasound at 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
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

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

  • Planned cesarean
  • Primary cesarean
  • ≥ 38 gestational weeks

排除标准

  • Previous cesarean
  • Women < 18 years old
  • Multiple gestation
  • Mullerian anomalies
  • Active labor
  • BMI >35 kg/m2
  • Placenta praevia
  • Chronic systemic disease

结局指标

主要结局

Mean myometrium thickness

时间窗: 6 months after intervention

Using transvaginal ultrasound the residual myometrium thickness at the site of the uterine scar will be measure.

次要结局

  • Operative time(Same day of intervention: day 1)
  • Mean number of haemostatic sutures(Same day of intervention: day 1)
  • Estimated blood loss(Same day of intervention: day 1)

研究者

发起方
CHU de Quebec-Universite Laval
申办方类型
Other
责任方
Principal Investigator
主要研究者

Emmanuel Bujold

MD, MSc

CHU de Quebec-Universite Laval

研究点 (2)

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