NCT06741371招募中不适用
Impact of Using Synthetic Absorbable Monofilament Versus Multifilament Suture Material for Uterine Closure on the Development of Uterine Isthmocele : A Rondamized Controlled Clinical Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- The incidence of isthmocele by transvaginal ultrasound 6 months after delivery
研究概览
简要总结
This thesis conducts the effect of using different suture materials on the development of uterine scar niche after cesarean section.
The difference between monofilament and multifilament sutures and the special properties of each one .
The primary outcome of the study is to know which material conducts more scar niche formation .
Secondary outcomes are the extent of blood loss , the need of extra hemostatic sutures
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
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age: 20-45 years old
- •Singleton pregnancy.
- •Gestational age between 37 completed weeks to 42 weeks.
- •Patients undergoing elective primary caesarean section
排除标准
- •History of uterine surgery (e.g. hysterotomy, myomectomy, perforation, caesarean section). (to be able to differentiate between the recent CS scar and the old scar)
- •Abnormal placental invasion (placenta previa and accrete ) ( more liable to undergo Cesarean hysterectomy)
- •Uterine anomalies (e.g., septum, Mullerian anomalies or fibroids). (may be localized at the suture line and therefore affect the scar)
- •Drugs intake that affects bleeding or tissue healing e.g., anti-coagulants, immunosuppressive drugs and chronic use of steroids (more than 14 days pre-operative)
- •Any medical Co-morbidity (diabetes mellitus, Hypertension and Thyroid abnormalities) (more liable to affect the healing)
研究组 & 干预措施
Monocryl arm
Experimental
干预措施: Monocryl (Procedure)
Vicryl arm
No Intervention
结局指标
主要结局
The incidence of isthmocele by transvaginal ultrasound 6 months after delivery
时间窗: 6 months
Effect of using monofilament sutures on the development of uterine scar niche
次要结局
未报告次要终点
研究者
Mohammed Essam ElDin Mohammed
Assistant lecturer
Ain Shams Maternity Hospital
研究点 (1)
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