Compare Prostaglandin E2 Against to Combined Use of Transcervical Foley Catheter Balloon With Vaginal Prostaglandin E2 for Induction of Labor at Term: A Randomized Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- induction-to- delivery time
研究概览
简要总结
This study evaluates the addition of transcervical Foley catheter balloon and vaginal prostaglandin E2 in induction of labor at term. Half of participants will be used combine transcervical Foley catheter balloon and vaginal prostaglandin E2, while the other half will be used alone vaginal prostaglandin E2.
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.
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,
- •a category II or III fetal heart rate pattern,
- •anomalous fetus,
- •fetal demise
- •women with immediate delivery indications -
研究组 & 干预措施
Propess with Foley balloon catheter
10 mg PGE2 vaginal ovul will be inserted to the posterior fornix and an 18-F Foley catheter which filling with 30 mL of saline solution will be placed into the cervix
干预措施: Foley catheter (Device)
Propess with Foley balloon catheter
10 mg PGE2 vaginal ovul will be inserted to the posterior fornix and an 18-F Foley catheter which filling with 30 mL of saline solution will be placed into the cervix
干预措施: PGE2 (Drug)
Propess vaginal ovule
10 mg PGE2 vaginal ovule will be inserted to the posterior fornix
干预措施: PGE2 (Drug)
结局指标
主要结局
induction-to- delivery time
时间窗: the length of time between the beginning of induction and the end of 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(the length of time between the beginning of induction and the onset of labor)
研究者
Ahmet Eser
medical doctor
Zeynep Kamil Maternity and Pediatric Research and Training Hospital