Induction of Labor With Single and Double Balloon Catheters, a Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Cervix dilatation >= 3cm
研究概览
简要总结
A randomized controlled double blinded study to investigate whether a specially designed double balloon catheter is more efficient than a foley catheter for cervical ripening and induction of birth.
160 women with singleton term pregnancies with un ripe cervix and no contraindications for catheters will be included and randomized to either double og single balloon catheters for cervical ripening. Efficacy wil be assessed at removal of the catheter, measured by the amount of women where the cervix has become ripe enough for amniotomy.
Our hypothesis is that double balloon catheters will give a greater amount of women where amniotomy upon catheter removal is possible. Secondary outcomes as time from induction till birth, vaginal deliveries and complications during or after birth for the mother or child will also become recorded.
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, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Singleton pregnancy above week 37
- •Indication to induce birth
- •Unripe cervix
- •Term date set by US before week 21
排除标准
- •Ripe cervix
- •Prematurity (<37w)
- •Letal malformations
- •Low lying placenta
- •Multiple pregnancies
- •Breakage of amniotic fluid
- •The woman does not understand norwegian
结局指标
主要结局
Cervix dilatation >= 3cm
时间窗: At cather removal
Cervix dilatation is assessed by vaginally examination at Catheter removal.
次要结局
未报告次要终点