Isthmocele After Endometrial and Non-endometrial Suturing in Cesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Number of patients with isthmocele six month after cesarean section
研究概览
简要总结
This study compares the effect of two techniques of uterine closure, with or without endometrial suturing on isthmocele development after cesarean section.
详细描述
Cesarean section is the most common surgery performed on pregnant women. Poor healing of the incision of the uterus leads to isthmocele development. Long-term morbidities associated with isthmocele are uterine scar pregnancy, uterine perforation, pelvic pain, and spotting-style bleeding after menstruation. Many factors that may affect the healing of uterine scar have been studied in the literature (i.e. Double or single-layer closure, locked or unlocked closure, uterine retroflection). Suturing complete fold of the wound lips during the closure of the uterus may cause the endometrial layer to be embedded in the myometrium and to form niche tissue. The study hypothesized that isthmocele development can be reduced by suturing without enclosing the endometrium during uterine closure.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Term pregnancy (≥37 weeks of gestation)
- •Singleton pregnancy
- •Primary cesarean
排除标准
- •Previous cesarean section
- •Previous uterine surgery
- •Multiple gestations
- •Mullerian anomalies
- •Active labor
- •Placenta previa/accreta
研究组 & 干预措施
Entire fold uterine closure
The uterus will be sewn with full fold locked sutures that pass through myometrium and endometrium.
干预措施: Closure of the uterus with endometrium at the time of cesarean (Procedure)
Non-endometrial uterine closure
The uterus will be sewn with locked sutures that pass through myometrium without endometrium.
干预措施: Closure of the uterus without endometrium at the time of cesarean (Procedure)
结局指标
主要结局
Number of patients with isthmocele six month after cesarean section
时间窗: 6 months after intervention
Residual myometrium thickness of less then 2.5 mm with transvaginal ultrasonography
Mean myometrium thickness
时间窗: 6 months after intervention
Myometrial thickness measured at incision site with transvaginal ultrasonography
次要结局
- Spotting(6 months after intervention)
研究者
Şener Gezer
Principal Investigator
Kocaeli University