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临床试验/NCT04871022
NCT04871022已完成不适用

Double-layer Versus Purse Uterine Closure Techniques : Impact on Residual Myometrial Thickness After Cesarean

University Tunis El Manar2 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2021年5月15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
126
试验地点
2
主要终点
Residual myometrium thickness

研究概览

简要总结

There are different surgical techniques of uterine closure during cesarean. Currently data suggest that the double layer unlocked closure technique is associated with better uterine scar healing, and this technique is considered the gold standard.

This study compares two techniques of uterine closure on myometrium thickness:

  1. Double layer unlocked suture;
  2. Purse suture of the uterus with a first continuous purse suture of the deep portion of the myometrium and a second unlocked continuous suture including the remaining part of the myometrium.

The primary outcome is the mean residual 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
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 48 Years(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
  • Covid-19 infection

结局指标

主要结局

Residual myometrium thickness

时间窗: 6 months after intervention

次要结局

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

研究者

发起方
University Tunis El Manar
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Halouani

MD

University Tunis El Manar

研究点 (2)

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