跳至主要内容
临床试验/NCT05510349
NCT05510349Unknown不适用

Prevention of Per-partum Fetal Hypoxia: Measure of Placental Elasticity and Viscosity During Labor

Centre Hospitalier Universitaire de Besancon0 个研究点目标入组 150 人开始时间: 2022年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
主要终点
Placental elasticity in kilopascals (kPa)

研究概览

简要总结

Fetal heart rate (FHR) monitoring during labor aims to detect fetuses at risk of intrapartum hypoxia in order to accelerate their birth before the constitution of sequelae such as anoxic encephalopathy and cerebral palsy. But the positive predictive value of FHR monitoring is low, and many second-line tests have been proposed but none of them has been proven to be conclusive. Measure of placental elasticity and viscosity during labor could be a new second line test to complete the FHR monitoring. Several studies have shown that placental elasticity is increased in case of gestational diabetes, preeclampsia, or intrauterine growth restriction, but no study has focused on placental elasticity during labor. The investigators hypothesize that placental elasticity and viscosity could reflect the quality of maternal-fetal exchanges during labor, and could help to detect fetus at risk of intrapartum hypoxia.

The first aim of this study is to describe the values of placental elasticity and viscosity during different points in the labor: beginning of the labor, beginning of the active phase of the first stage of labor, and passive phase of the second stage of labor.

Secondary aims of this study are: to describe the values of placental elasticity and viscosity in case of oxytocin infusion, in case of abnormal FHR, and ex-vivo after placental expulsion.

This unicentric observational prospective study will include 150 patients with singleton pregnancy, without pathology, with spontaneous labor at term.

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 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • singleton pregnancy
  • spontaneous labor at term
  • body mass index < 30 at the beginning of the pregnancy
  • anterior, lateral or fundal placenta
  • epidural analgesia at the beginning of the labor
  • normal fetal heart rate at the beginning of the labor

排除标准

  • gestational diabetes
  • preeclampsia
  • intrauterine growth restriction

结局指标

主要结局

Placental elasticity in kilopascals (kPa)

时间窗: Day 1

beginning of the labor

Placental viscosity in Pascal.seconde (Pa.s)

时间窗: Day 1

beginning of the labor

次要结局

  • Placental viscosity in Pascal.seconde (Pa.s)(Day 1)
  • Placental elasticity in kilopascals (kPa)(Day 1)

研究者

申办方类型
Other
责任方
Sponsor

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