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临床试验/NCT03126136
NCT03126136已完成不适用

Predictive Value of a Postural Test on Pulse Pressure Variation During Labor With Epidural Analgesia on Fetal Heart Rate Abnormalities

Hopital Foch8 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2018年12月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Hopital Foch
入组人数
1
试验地点
8
主要终点
Fetal heart rate

研究概览

简要总结

Fetal heart rate abnormalities are common. Miller et al. have demonstrated that new onset fetal heart rate abnormalities after initial labor epidural dosing occur more frequently in women with a low admission pulse pressure than those with a normal admission pulse. The aim of the present study is to look for a statistical link between the occurrence of a fetal heart abnormality requiring an intervention and maternal hemodynamic factors (blood pressure, pulse pressure, and cardiac output) measured before epidural analgesia in two positions: dorsal decubitus position and in the left lateral decubitus.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

入选标准

  • pregnant women
  • gestational age ≥ 36 weeks
  • single eutrophic fetus
  • wishing for epidural analgesia
  • cervical dilatation less than or equal to 5 cm
  • spontaneous labor
  • scheduled for a vaginal delivery.
  • Non-inclusion Criteria:
  • prematurity (< 36 weeks of amenorrhea) or post-term birth
  • intention of induction of labour using oxytocin before epidural analgesia or prostaglandin
  • contraindication to epidural analgesia
  • history of hypertension or gravidic hypertension or heart disorder
  • gestational diabetes
  • foetal malformation or oligohydramnios or fetal growth abnormality
  • fœtal macrosomia diagnosed by ultrasonic scanning
  • hematocrit less than 20%
  • Exclusion Criteria
  • induction of labour using oxytocin before epidural analgesia
  • newborn weight > 4kg at birth

排除标准

  • 未提供

结局指标

主要结局

Fetal heart rate

时间窗: 4 days

Fetal heart rate abnormalities occurring during the first hour of epidural analgesia and requiring an intervention. Relationship between maternal hemodynamic factors (heart rate, blood pressure, pulse pressure, and cardiac output) measured before epidural analgesia in two positions (dorsal decubitus position and in the left lateral decubitus) and fetal heart rate abnormalities occurring during the first hour of epidural analgesia and requiring an intervention.

次要结局

  • Newborn heart rate, blood pressure, pulse pressure, and cardiac output(4 days)
  • Mode of delivery(4 days)
  • Number of patients with hemodynamic abnormalities(4 days)
  • Fetal heart rate(4 days)

研究者

发起方
Hopital Foch
申办方类型
Other
责任方
Sponsor

研究点 (8)

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