Comparison of Outcome of Foley Catheter Versus Misoprostol for Induction of Labor at Term Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Delivery of the fetus
研究概览
简要总结
There are gaps in the local data regarding the comparative effectiveness of Foley catheter versus misoprostol for induction of labor (IOL). Therefore, the current study was planned with the objective of comparing the mean induction-to-delivery interval of Foley catheter versus misoprostol for IOL in singleton term pregnancy.
详细描述
Although systematic reviews and meta-analyses have compared the effectiveness and safety of pharmacologic, nonpharmacologic, mechanical, and combined methods of cervical ripening and labor induction, the optimal method of IOL is still debatable. The findings would be helpful in further assessing the conflicting evidence and furnishing the limited data regarding the use of Foley catheters or misoprostol in patients undergoing IOL from local setups.
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
- 否
入选标准
- •Pregnant females
- •18-40 years
- •With a singleton term pregnancy (37-41) weeks
- •Parity < 4
- •Vertex presentation (on ultrasound scan)
- •Intact membranes (on history and clinical examination)
- •Going through labor induction
排除标准
- •With a previous uterine surgery
- •Non-reassuring cardiotocography (CTG)
- •Oligohydramnios (on ultrasound scan)
- •Intrauterine growth restriction (IUGR) (on ultrasound scan)
- •Abruptio placenta (on ultrasound scan).
研究组 & 干预措施
Misoprostol Group
Women received intravaginal misoprostol 25 μg 4 hours apart, up to a maximum of four doses.
干预措施: Misoprostol (Drug)
Foley Group
An intracervical Foley catheter (16 F) was inserted into the patients. The balloon was inflated with 30 mL of sterile normal saline solution and was kept in place until it expelled spontaneously.
干预措施: Foley catheter (Device)
结局指标
主要结局
Delivery of the fetus
时间窗: 24 hours
Induction-to-delivery interval was calculated from the insertion of the Foley catheter or misoprostol until the delivery of the fetus in hours.
次要结局
未报告次要终点
研究者
Muhammad Aamir Latif
Research Consultant
RESnTEC, Institute of Research