Outpatient Versus Inpatient Cervix Priming With Foley Catheter
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 主要终点
- variation of bishop score (difference between bishop score before and after application of foley catheter)
研究概览
简要总结
The aim was to conduct a non-blinded prospective randomized study at a tertiary hospital. Inclusion criteria: term pregnancy with a single fetus in cephalic presentation, Bishop score < 6, gestational age > 41 weeks or medical indication for induction of labor.
Patients will be randomized to outpatient or inpatient cervix priming with Foley catheter.
The primary outcome will be to compare the variation of Bishop score (difference between Bishop score before and after application of Foley catheter) between outpatient and inpatient groups. Secondary comparisons include: mode of delivery, Foley catheter application-to-delivery time, inpatient time, sequential use of prostaglandins, infection and maternal pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women with a single fetus in cephalic presentation
- •Bishop score < 6
- •Gestational age > 41 weeks or medical indication for induction of labor submitted to cervix priming with Foley catheter
排除标准
- •women with a fetus in noncephalic presentation
- •an indication for elective cesarean delivery
- •spontaneous labor
- •hydramnios (amniotic fluid index ≥ 25)
- •nonreassuring cardiotocogram
- •multiple pregnancy
- •rupture of membranes
- •active vaginal bleeding
- •indication for prophylaxis of Streptococcus group B infection
- •HIV infection
- •cervical injury
- •previous cesarean section with recurrent indication
结局指标
主要结局
variation of bishop score (difference between bishop score before and after application of foley catheter)
时间窗: up to 24 months
次要结局
- mode of delivery(up to 24 months)
- maternal pain evaluated by visual analog scale for pain(up to 24 months)
- induction-to-delivery time(up to 24 months)
研究者
Catarina Policiano
Dr. Catarina Policiano
Hospital de Santa Maria, Portugal