Comparing Combined Foley Catheter Balloon and PGE2 Vaginal Ovule With Early Amniotomy and PGE2 for Induction of Labor at Term: A Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- induction-to- delivery time
研究概览
简要总结
This study evaluates the intervention for induction of labor with low bishop scores . One group will be induced by transcervical Foley catheter balloon and vaginal PGE2 and other group will be induced by early amniotomy and PGE2 vaginal ovule for induction of labor at term.
详细描述
An unfavorable cervix during induction decreases the success rate of labor induction and vaginal delivery. Therefore it is required to apply cervical ripening methods for unfavorable cervices. Application of transcervical Foley catheter is an effective mechanical method and has the advantages of lower cost and lowest rate of fetal heart rate changes due to tachysystole compared with PGE1 and PGE2. Despite the advantages of mechanical methods, PGE1 and PGE2 are reported to be more effective than mechanical methods to achieve vaginal delivery within 24 hours. Although there are a lot of studies comparing PGE1, PGE2 and transcervical Foley balloon catheter separately and PGE1 combined with transcervical Foley balloon catheter, less is known about combined usage of PGE2 and transcervical Foley balloon catheter. Early amniotomy is another effective method to ripen cervix. we aim to evaluate which method is superior to another.
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
- •singleton pregnancy,
- •gestational age ≥37 weeks,
- •intact membranes,
- •cephalic presentation,
- •bishop score ≤5,
- •had obstetrical indications for induction of labor,
- •had less than three uterine contractions in every 10 minutes.
排除标准
- •Patients who had contraindications for vaginal delivery,
- •previous uterine surgery,
- •fetal malpresentation,
- •multifetal pregnancy,
- •more than three contractions in 10 minutes,
- •contraindications to prostaglandins,
结局指标
主要结局
induction-to- delivery time
时间窗: from the beginning of induction until the labor
the length of time between the beginning of induction and the end of labor
次要结局
- induction-to-active phase of labor time(from the beginning of induction until the labor)
研究者
Ahmet Eser
Principal investigator
Zeynep Kamil Maternity and Pediatric Research and Training Hospital