Sleep Disturbances and Depression of the Mother Affect to the Pain During Balloon Catheter Induction of Labour
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 VAS
研究概览
简要总结
Randomised trial comparing double balloon catheter for induction of labor between inpatient and outpatient groups. The investigators assess how sleep disturbances and depression of the mother affect to the pain during balloon catheter induction of labour.
详细描述
Participants included to this randomised study are women with uncomplicated singleton pregnancy with ≥ 37- ≤ 41+5 weeks of gestation. Participants are randomised to two groups: one hundred are randomised 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 investigators assess also the effect of the sleep disturbance and depression of the mother to the pain during balloon catheter induction of the labour.
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
盲法说明
Open Label
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •uncomplicated pregnancy
- •singleton pregnancy
- •pregnancy weeks ≥ 37 - ≤ 41+5
- •the patient is living in1/2 hour away from hospital
排除标准
- •patient has a disease that is effecting to the pregnancy e.g. pre-eclampsia, gestational hepatosis
- •the patient has medical treatment of diabetes
- •baby is not growing normally
- •multiple pregnancy
- •preterm rupture of membranes
- •earlier caesarean section
- •the patient is living more than 1/2 hour away from hospital
结局指标
主要结局
The pain measured by VAS
时间窗: one to 14 days after induction of the labor
The pain measured by VAS after double balloon catheter insertion.
次要结局
- The effect of depression of the mother to the pain assessed by VAS(one to 14 days after induction of the labor)
- The affect of the sleep disturbances of the mother to the pain assessed by VAS(one to 14 days after induction of the labor)
- The maternal and neonatal morbidity after balloon catheter induction(one to 14 days after induction of the labor)
- The total hospital stay in both groups(one to 14 days after induction of the labor)
研究者
Kirsi Rinne
Senior Doctor
Turku University Hospital