Comparison of Foley Catheter and Double-balloon Catheter in Second Trimester Pregnancy Termination
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- induction termination interval
研究概览
简要总结
The efficiency of double-balloon and Foley catheters in the second trimester medical termination of pregnancies will be compared.
详细描述
Women will be randomised into two groups. Foley catheter was applied to one group and double balloon catheter to the other group. After catheter expulsion or if the catheters did not spontaneously expulsed after 24 hours, i.v. oxytocin infusion will be started. Abortions will be considered successful if there will be no need of another method for abortion.
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
- •pregnancy termination, gestational age from 14-24 weeks
排除标准
- •multiple gestation
研究组 & 干预措施
Foley catheter
Foley catheter will be inserted through the cervical os and it will be filled with 40 ml saline. After insertion gentle traction will be applied for cervical ripening. Pregnancy termination will be achieved.
干预措施: pregnancy termination (Device)
Double-balloon catheter
Double-balloon catheter will be inserted through the cervical os and both baloons will be filled with 40 ml saline. No traction will be applied. Pregnancy termination will be achieved.
干预措施: pregnancy termination (Device)
结局指标
主要结局
induction termination interval
时间窗: during procedure
time from induction to pregnancy termination
次要结局
未报告次要终点
研究者
Berna Aslan Cetin
Md, ObGYN
Kanuni Sultan Suleyman Training and Research Hospital