Epidural Analgesia and Troubles of Fetal Cardiaq Rythm : Effect of the Systemic Transfer of Ropivacaine and Sufentanil
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Plasmatic concentrations compared maternal ropivacaine based on the presence of abnormal fetal heart rate
研究概览
简要总结
The aim of the investigators study is to demonstrate the association between fetal cardiac rhythm abnormalies after epidural analgesia and the maternal systemic transfer of ropivacaine and/or sufentanil.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •18 years old or more
- •nulliparous
- •_ one fetus
- •head first
- •spontaneous labor
- •epidural analgesia
- •no fetal cardiac rhythm abnormalies before the epidural analgesia
- •no active management of labor during 30 minutes after the epidural analgesia induction
- •signature of the consent form
排除标准
- •pathological pregnancy
- •low maternal blood pressure during the 30 minutes after the epidural analgesia
- •uterin contraction which last for 5 minutes or more
- •more than 6 uterin contractions during a 10 minutes period
- •Ropivacaine contraindication
- •sufentanil contraindication
研究组 & 干预措施
control group
patient at term, spontaneous labor, without any fetal cardiac rhythm abnormalies during the 30 minutes after the epidural analgesia induction
干预措施: ropivacaine (Drug)
fetal cardiac rhythm abnormally
patient at term, in spontanous labor with fetal cardiac rythm abnormally which occurs 30 minutes after the epidural analgesia induction
干预措施: ropivacaine (Drug)
结局指标
主要结局
Plasmatic concentrations compared maternal ropivacaine based on the presence of abnormal fetal heart rate
时间窗: 1 day
Maternal Plasmatic concentrations of ropivacaine will be measured in mg / liter of maternal blood and the median of each group will be compared by paired Wilcoxon test
次要结局
- Plasmatic concentrations compared maternal sufentanil based on the presence of abnormal fetal heart rate(1 day)