Randomized Controlled Trial Comparing Three Techniques of Uterine Closure on the Myometrium Thickness Evaluated With Ultrasound Six Months After a Primary Cesarean
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
- 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
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
Emmanuel Bujold
MD, MSc
CHU de Quebec-Universite Laval
