NCT02932319已完成不适用
Outpatient Foley Catheter for Induction of Labor in Nulliparous for Prolonged Pregnancy
University Hospital, Lille5 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2017年3月31日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 5
- 主要终点
- Bishop score
研究概览
简要总结
15 to 20 % of nulliparous needs an induction at term. None study has evaluated Foley catheter induction at home versus expectative in this population
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •prolonged pregnancy (D+4) nulliparous no complication during pregnancy location near th hospital (20 mn by car) Bishop < 6
排除标准
- •medical history small for gestationnal age PROM Live alone
研究组 & 干预措施
Foley catheter
Active Comparator
The patient will have an induction at home after 60 mn of fetal heart rate monitoring.
干预措施: Foley catheter (Device)
Expectative
Sham Comparator
The patient in this arm will have the actual care (expectative until the next day befor starting the induction)
干预措施: expectative (Other)
结局指标
主要结局
Bishop score
时间窗: at term birth +5 days
Measure the evolution of Bishop score,change between the randomization and the return of the patient
次要结局
- Fetal complications(through study completion, at 4 day)
- number of birth(between the term consultation + 4 days (randomization) and delivery time)
- Neonatal complications(through study completion, at 4 day)
- Total dose of prostaglandin used in case of cervical ripening.(During labor)
- Total dose of Ocytocin used or not for induction labor(During labor)
- Labour ward(at term birth +5 days)
- Utilization rate of oxytocin(During labor)
- Caesarean rate(before labor and during labor)
- Maternal complications(through study completion, at 4 day)
- delivery rate(within 24 hours and 48 hours after randomization)
- Duration of hospital stay(through study completion, at 4 day)
研究者
研究点 (5)
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