COSMOSS Study, Comparison Of Suture Materials on Sectio Scars. A Multicenter Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Isthmocele Rate
研究概览
简要总结
This multicenter prospective randomized controlled trial aims to investigate the ishtmocele rates after c-section delivery depending on using different suture materials for the uterine closure.
详细描述
The study involves 5 health centers (two universities, three private hospitals). Patients who will undergo their first cesarean section because of any etiology (except emergent cases) will be included in the study. Operation Nurse will randomize the patients into two groups depending on the monofilament or poly filament suture material. Patients will be checked by transvaginal ultrasound on a postoperative day one, postoperative first month, and postoperative sixth month. As the primary result, the istmocele rates will be compared between the study groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18-40 yrs women
- •Primary elective cesarean section
- •First delivery
- •Without any systemic diseases
排除标准
- •emergent delivery
- •previous c-section history
- •congenital uterine abnormality
结局指标
主要结局
Isthmocele Rate
时间窗: 6 months
diagnosis of isthmocele during 6th month ultrasound check.
次要结局
未报告次要终点
研究者
GÜRKAN UNCU,PROF. MD
M.D, Professor
Uludag University
