NCT02013752Unknown2 期
Randomized Controlled Trial (RCT) of Primiparous Women Using the Modified Perineal Protection Device
Knut Haadem2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年3月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Length of delivery tear measured in cm with ruler
研究概览
简要总结
The purpose of this study is to determine whether a modified perineum protection device can reduce tearing during delivery.
详细描述
RCT investigation using a modified device during delivery of the baby's head (an earlier model has proved successful) and assess whether the use can decrease delivery tears as measured in length.
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 at term (week 36 - 41)
排除标准
- •Age below 18
- •Breech delivery
- •Not understanding written and oral information
结局指标
主要结局
Length of delivery tear measured in cm with ruler
时间窗: at delivery - Participants will be followed for the duration of the first 24 hours
The outcome measured is the occurrence of first and second degree vaginal and perineal tears during delivery.
次要结局
- Adverse effects of the device on mother and child(at delivery-Participants will be followed for the duration of the first 24 hours)
研究者
Knut Haadem
M.D., PhD
Helsingborgs Hospital
研究点 (2)
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