Assessment of Pain With Insertion of the Foley Catheter for Induction of Labour
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Pain assessed by VAS and SCA, in women randomised to digital or speculum placement of a Foley catheter.
研究概览
简要总结
The purpose of this study is to assess pain in women randomised to digital or speculum placement of a Foley catheter. Pain during cervical ripening with the Foley catheter is also to be evaluated as well as maternal satisfaction with induction of labour.
详细描述
The most common method described for placing the Foley catheter is under direct visualisation of the cervix during a sterile speculum examination. Another method is to place the catheter during a digital cervical examination.
Maternal discomfort/pain during speculum placement of the catheter has been evaluated in a few studies whereas studies that compare the digital method with the speculum method of placement are lacking.
The visual analogue scale is used to subjectively assess pain. With a skin conductance algesimeter an objective assessment of pain is possible.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 fetus in cephalic presentation with a Bishop score of 3-5 and
- •indication for induction of labour
排除标准
- •low-lying placenta,
- •undiagnosed vaginal bleeding,
- •more than one previous caesarean section,
- •previous use of an induction or pre-induction agent during the same pregnancy,
- •signs of infection (maternal fever)
- •non- proficiency in the Swedish language.
结局指标
主要结局
Pain assessed by VAS and SCA, in women randomised to digital or speculum placement of a Foley catheter.
时间窗: At insertion of Foley catheter
次要结局
- To assess pain with VAS and SCA during cervical ripening with the Foley catheter and to evaluate maternal satisfaction. To evaluate if markers of stress in blood and amniotic fluid correlate with VAS and SCA.(During treatment with Foley catheter. At expulsion of Foley catehter)