Continuous Versus Interrupted Sutures for Repair of Episiotomy or Second Degree Tears: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 445
- 试验地点
- 2
- 主要终点
- Pain at that moment ("pain now")
研究概览
简要总结
The best technique for this repair would be that which requires least time in realisation, least consumption of material for the repair and that which produces less pain at short and long-term permitting the resumption of intercourse quicker and with less pain thereby requiring less necessity to take out the stitches and less frequency of re stitching. The investigators research is looking for a technique for repairing the perineum more advantageously.
详细描述
445 women who participated in the project had undergone normal deliveries with episiotomy or second-grade tearing of the perineum. One group was repaired with continuous non-locking suture in the vagina, perineum and subcutaneous tissue. The other group used continuous locking suture of the vagina, interrupted sutures in the perineum muscle and interrupted transcutaneous suture. The threads used for stitching were identical in both groups. The same questions were asked concerning the sensation of pain and the use of painkillers, the second and the tenth day and at the three months.
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
- Double (Participant, Investigator)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •vaginal childbirth
- •at least 37 weeks of gestation
- •assistance by one of the 4 matrons who participated in the project
- •have been subjected to an episiotomy or the appearance of tearing that affected skin and muscle
- •The newborn child had to be alive, viable
排除标准
- •instrumentation
- •produce injury in the anal sphincter or in the rectum.
- •serious congenital malformations.
结局指标
主要结局
Pain at that moment ("pain now")
时间窗: the second and the tenth day and at the three months.
次要结局
- If sexual intercourse had been re initiated, how long after childbirth, if pain had been experienced the first time and if this continued.(at the three months.)