Evaluation of Single Versus Double-layer Technique by Closure of Cesarean Uterine Incision. A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Myometrial thickness
研究概览
简要总结
The study compares short-term and long-term effects on myometrial thickness in women sutured by single- or double-layer technique by closure of cesarean uterine incision. The study is a randomized clinically controlled study.
详细描述
Objective
To compare short-term and long-term effects on myometrial thickness in women sutured by single- or double-layer technique by closure of cesarean uterine incision. The study is a randomized clinically controlled study.
Design:Follow-up by ultra sound of a randomised controlled trial. Surgical technique was blinded for the investigator.
Setting: An obstetric department in a tertiary referral hospital, 2008-2013. Participants: Healthy nulliparous scheduled for elective caesarean section randomly assigned to closure of the uterine incision by single- or double layer techniques.
Intervention: A modified version of the Misgav-Ladach surgical technique was used. The women were examined by abdominal ultra sound before discharge from the maternity ward, and by vaginal ultra sound and hysterosonography minimum five month post partum.
Main outcome measure: Thickness of the remaining myometrium corresponding to the former cesarean uterine incision measured by ultra sound.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women submitted to cesarean sectio
排除标准
- •Exclusion criteria were: Former uterine operations such as myomectomy or surgery resulting in entering the cavity, fibroids located in the cervix or the cervicalcorporal border, inflammatory bowel disease, SLE, rheumatoid arthritis, IDDM, re-operations after inclusion or the cesarean section and more than three additional single sutures for hemostasis.
研究组 & 干预措施
Suturing in a single layer
The technique used for single layer to close the uterine incision following cesarean sectio
干预措施: Suturing in a single layer (Procedure)
Suturing in two layer
The technique used for two layer technie to close the uterine incision following cesarean sectio
干预措施: Suturing in two layer (Procedure)
结局指标
主要结局
Myometrial thickness
时间窗: 5 months
Thickness of the remaining myometrium corresponding to the former cesarean uterine incision measured by ultra sound
次要结局
未报告次要终点