NCT00690040已完成不适用
Single Balloon Catheter Compared With Double Balloon Catheter for Ripening of the Unfavorable Cervix
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 293
- 试验地点
- 1
- 主要终点
- Average Time in Hours From Insertion of the Catheter Until Delivery
研究概览
简要总结
The purpose of this study is to compare between single balloon catheter and double balloon catheter for ripening the cervix among pregnant with unfavorable cervix.
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 48 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Induction of labor is indicated
- •Gestational age between 24 - 42 weeks
- •Singleton pregnancy
- •Bishop score less than 7
排除标准
- •Any contraindication for vaginal delivery
- •Previous cesarean delivery
- •Low lying placenta
- •Rupture of membranes
- •Fetal malformations incompatible with life
- •intrauterine fetal death
- •Amnionitis
- •Genital viral infection (HIV, hepatitis C virus
- •, hepatitis B virus)
- •Allergy to latex
研究组 & 干预措施
1
Active Comparator
Ripening of the unfavorable cervix is done with Single balloon catheter (Foley catheter)
干预措施: Foley catheter (Device)
2
Active Comparator
Ripening of the unfavorable cervix is done with double balloon catheter (Atad catheter)
干预措施: Atad catheter (Device)
结局指标
主要结局
Average Time in Hours From Insertion of the Catheter Until Delivery
时间窗: At the end of the study
次要结局
- To Compare Mode of Delivery, Catheter's Side Effects and Woman's Satisfaction Between the Groups(At the end of the study)
研究者
Raed Salim
MD
HaEmek Medical Center, Israel
研究点 (1)
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