Study of Perineal Protection Device
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,200
- 试验地点
- 2
- 主要终点
- Grade I and II rupture during delivery
研究概览
简要总结
Objective:
To investigate the protective effects of a newly invented device for reducing tears in the perineum during vaginal childbirth.
Design:
A multicenter randomized control trial performed at three hospitals in Sweden, in Helsingborg, Lund and Malmö. Participants recruited are women with vaginal delivery (N=1200), cephalic presentation. They will be randomized to an intervention group, with a perineal protection device, and a control group deliver as normal.
Main outcome measures:
The effect on the frequency and extension of perineal ruptures grade I, II and anal sphincter rupture are measured.
详细描述
Perineal rupture shall be measured with a ruler. Anal sphincter ruptures be examined by physicians. Drawing be made of the tears by the midwife.
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Vaginal delivery
排除标准
- •Age below 18 years and no understanding of written and oral information.
结局指标
主要结局
Grade I and II rupture during delivery
时间窗: time at the delivery department (up to 12 months)
Number and extension of perineal tears during delivery
次要结局
未报告次要终点
研究者
Knut Haadem
Principal investigator
Helsingborgs Hospital