Influence of Measurement Method of Labor Contractions on Labor Outcome and Newborn
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,500
- 试验地点
- 2
- 主要终点
- Number of cesarean sections
研究概览
简要总结
In this study, parturients will be randomized to either internal or external tocodynamometry contractions' follow up. Investigators recruit primiparous, those who try to have vaginal birth after cesarean section and multiparous, who need oxytocin during labor. Primary endpoint is the number of operative labors in each group. Secondary endpoints are the duration of labor, the use of oxytocin and the condition of the newborn.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •gestational age ≥ 37 weeks
- •singleton pregnancy
- •a fetus in cephalic position
- •normal cardiotocograph in the time of randomization
- •cervical ripening < 7 cm
- •either 1) primipara, 2) multipara, who needs oxytocin during first stage of labor or 3) parturients with previous cesarean section
排除标准
- •parturient with hepatitis or HIV or other significant viral infection
- •Acute infections (fever over 37,5, or C-reactive protein over 20) in the time of randomization
- •Estimated fetal weight over 4,5 kg
- •Suspected fetal abnormality
研究组 & 干预措施
Intrauterine pressure catheter
Intrauterine pressure catheter is used during labor to follow up the contractions
干预措施: Intrauterine pressure catheter (Device)
External tocodynamometry
External tocodynamometry is used during labor to follow up the contractions
干预措施: External tocodynamometry (Device)
结局指标
主要结局
Number of cesarean sections
时间窗: through study completion, an average of 6 years
Number of operative vaginal deliveries
时间窗: through study completion, an average of 6 years
次要结局
- Newborn admission to the pediatric care unit(3 days after birth)
- The use of Oxytocin during labor(From beginning of the use of oxytocin to the birth)
- Duration of labor(From time of first regular contraction to birth)
- Apgar scores(10 min after birth)
- Ph of umbilical artery(immediately after birth)
研究者
Tuija Hautakangas
Medical doctor
Tampere University Hospital