Surgical Incision Closure Method to Prevent Niche Formation After Cesarean Section- Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 183
- 试验地点
- 1
- 主要终点
- Formation of a uterine niche
研究概览
简要总结
In the last decade we have been exposed to the complication of a caesarean section called a "niche". A niche is an anaerobic defect in the location of the cesarean section, which represents the discontinuity of the endometrium and myometrium. A niche is usually diagnosed by ultrasound, and can also be diagnosed by hysterosalpingogram or hysteroscopy. In the presence of a niche women suffer more frequently from irregular bleeding, dysmenorrhea, chronic pelvic pain, and dyspareunia. We believe that a combination of tissue ischemia and thinning of the scar tissue that forms, causes a niche to form. Large randomized studies regarding the preferred surgical technique in cesarean section, including various methods of incision closure have found that there is no single method that is obviously superior. However, these studies did not examine niche formation as a complication of cesarean section.
In this study we will examine whether a unique incision closure method reduces post-cesarean niche formation.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 17 Years 至 50 Years(Child, Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women at first cesarean delivery
- •Women who consent to the study
排除标准
- •Women who are having a repeat caesarean section
- •Refusal to participate in the study
- •Urgent or emergent cesarean delivery
研究组 & 干预措施
New Closure Technique
This group will have the uterus closed after delivery of the fetus during cesarean section with a new technique.
干预措施: Niche prevention suture (Procedure)
Regular closure technique
The usual method of closing the surgical incision is to suture the entire wall of the uterus with a stratafix suture without locking the suture.
结局指标
主要结局
Formation of a uterine niche
时间窗: At least 12 weeks after delivery.
Presence of a uterine niche on ultrasound
次要结局
- Formation of a n abscess/hematoma(Up to 6 weeks after intervention)
- Blood loss over 1000 mL(At surgery)
- Need for repeat laparotomy(Up to 6 weeks after intervention)
- Duration of surgery(At surgery)
- Postoperative infection(Up to 6 weeks after intervention)
