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:
- Double layer unlocked suture;
- 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
- 是
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
Ahmed Halouani
MD
University Tunis El Manar
研究点 (2)
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