NCT01506388已完成3 期
Foley Catheter Plus Vaginal Isosorbide Mononitrate Versus Vaginal Misoprostol for Induction of Labour:a Randomised Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- caesarean section rate
研究概览
简要总结
The use of foley catheter was tested many times and proved to be effective for induction of labour.
详细描述
The investigators compare between vaginal misoprostol versus foley catheter plus vaginal isosorbide mononitrate (IMN) for induction of labour
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
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Term or post term pregnancies.
- •Live,singleton fetus.
- •Cephalic presentation.
- •Intact membrane.
- •Bishop score <
- •Not in labour.
- •Medically indicated for labour induction.
- •Primigravida or parity of 3 or less.
排除标准
- •Previous caesarean delivery.
- •Malpresentation.
- •Placenta previa.
- •Sever intrauterine growth restriction.
- •Multiple pregnancy.
- •Polyhydramnios.
- •Oligohydramnios.
- •Bishop score 7 or more.
研究组 & 干预措施
folye catheter plus vaginal IMN
Experimental
intracervical foley catheter plus vaginal IMN
干预措施: foley catheter (Device)
folye catheter plus vaginal IMN
Experimental
intracervical foley catheter plus vaginal IMN
干预措施: Vaginal IMN (Drug)
Misoprostol vaginally
Active Comparator
intravaginal misoprostol
干预措施: Misoprostol (Drug)
结局指标
主要结局
caesarean section rate
时间窗: 1 year
caesarean section
次要结局
- time from induction to delivery(1 year)
研究者
Waleed El-khayat
Principal investigator
Cairo University
研究点 (2)
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