A Randomized Trial of Foley Bulb and PGE2 for Labor Induction in Premature Rupture of Membranes
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 4
- 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 induction in premature rupture of membranes. 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.
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 ≥34 weeks,
- •rupture of membranes,
- •cephalic presentation,
- •bishop score ≤5,
- •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
PGE2 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 60 mL of saline solution will be placed into the cervix
干预措施: Foley balloon catheter (Device)
PGE2 vaginal ovule
10 mg PGE2 vaginal ovule will be inserted to the posterior fornix
结局指标
主要结局
induction-to- delivery time
时间窗: an average of one year
the length of time between the beginning of induction and the end of labor
次要结局
- neonatal outcome(an average of one year)
- admission to neonatal intensive care unit(an average of one year)
- tachysystole(an average of one year)
- postpartum hemorrhage(an average of one year)
- chorioamnionitis(an average of one year)
研究者
Ahmet Eser
M.D.
Zeynep Kamil Maternity and Pediatric Research and Training Hospital