NCT02410395Unknown不适用
NIche Development With Closure of Cesarean Uterotomy by Modified or Conventional Two-layer Technique (NICUM Study)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Presence of a cesarean scar niche more than 2 mm deep.
研究概览
简要总结
The aim of this trial was to compare two different uterotomy surgical techniques on the occurrence of a uterine niche and the risk of a number of short- and long-term gynecological complications associated with the presence and size of the niche.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Singleton pregnant
- •Intended elective cesarean section
排除标准
- •Cervical dilatation of more than 4 cm
- •Previous cesarean section
研究组 & 干预措施
Conventional technique
Active Comparator
Closure of the uterotomy with a conventional two-layer technique
干预措施: Conventional (Procedure)
Modified technique
Experimental
Closure of the uterotomy with a modified two-layer technique
干预措施: Modified (Procedure)
结局指标
主要结局
Presence of a cesarean scar niche more than 2 mm deep.
时间窗: 6 months
次要结局
- Residual myometrial thickness of the cesarean scar (RMT)(6 months)
- Cesarean scar niche depth, width, length, myometrium adjacent to the scar(6 months)
- Post-menstrual spotting(15 months)
- Incidence of cesarean scar pregnancy or spontaneous abortions(72 months)
- Adverse pregnancy outcomes in the following pregnancy(72 months)
研究者
研究点 (1)
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