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临床试验/NCT04766073
NCT04766073招募中不适用

Surgical Incision Closure Method to Prevent Niche Formation After Cesarean Section- Randomized Controlled Trial

Hadassah Medical Organization1 个研究点 分布在 1 个国家目标入组 183 人开始时间: 2021年7月22日最近更新:
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
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

Experimental

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

No Intervention

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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