Outpatient Versus Inpatient Double Balloon Catheter for Induction of Labor: a Randomised Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 2
- 主要终点
- The pain measured by visual analogy scale(VAS) after double balloon catheter
研究概览
简要总结
Randomized trial comparing double balloon catheter for induction of labor between in- and outpatient groups.Investigators assess feasibility, clinical effectiveness and patient acceptability of outpatient versus inpatient catheter for induction of labor.
详细描述
The objective of this study is to describe labor outcomes in women with double balloon induction catheter of labor. Participants included are women with uncomplicated singleton pregnancy of ≥37- ≤41+5 weeks of gestation. Patients are randomized to two groups: one hundred are randomized to the inpatient and one hundred to the outpatient group.
The main outcome measure is the pain evaluated by VAS at one, five, nine and 13 hours after the placement of double balloon induction catheter. The total hospital stay and induction to delivery interval time is measured. Also the mode of birth as well as maternal and neonatal morbidity and patient satisfaction are recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Health Services Research
- 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
- •uncomplicated pregnancy
- •singleton pregnancy
- •pregnancy weeks between >37 and <41+5
- •the patient is living in 1/2 hour away from hospital
排除标准
- •patient has any disease or medication
- •multiple pregnancy
- •pregnancy week > 41+5
- •preterm rupture of membranes
- •patient living more than 1/2 hour away from hospital
结局指标
主要结局
The pain measured by visual analogy scale(VAS) after double balloon catheter
时间窗: During the induction of the labor and postpartum period in the hospital.
Visual analogy score assessed by patient. Minimum 1mm to maximum 100 mm.
次要结局
- The total hospital stay in both groups(maximum 14 days)
- The maternal morbidity(during the induction of the labor and postpartum period in the hospital)
- neonatal morbidity(during the induction of the labor and postpartum period in the hospital)