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临床试验/NCT02813525
NCT02813525Unknown不适用

Ultrasound Monitoring of Fetuses With Vascular Intra-uterine Growth Restriction (IUGR) Using the Isthmus Systolic Index (ISI): Feasibility, Comparison to Normal Fetuses and Association With Perinatal Mortality

University Hospital, Bordeaux1 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2016年9月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
320
试验地点
1
主要终点
Compare the evolution of the values of the ISI in the fetus with IUGR relative to those of fetuses without IUGR fetuses for the same gestational age

研究概览

简要总结

Fetuses with IUGR, there is a correlation between Doppler indices of cardiovascular function and perinatal mortality. An index of systolic flow velocities at the aortic isthmus (ISI) has previously been described in a population of normal fetuses. Fetuses with IUGR, the velocities recorded in the aortic isthmus could be affected and the normal development of the ISI should be changed, because of the increase in placental resistance on one hand, and the gradual deterioration ventricular functions on the other one. Investigators hypothesize that the ISI index in the context of placental insufficiency could provide additional arguments on the extraction timing, the prognosis and the fetal extraction mode to severe hypoxia. The primary outcome of the study is to evaluate in an exploratory manner the feasibility and the potential interest of longitudinal monitoring of fetuses with IUGR by Doppler systolic isthmus and the calculation of the ISI index.

详细描述

Today evaluating the hemodynamic tolerance of the fetus with IUGR, is based on clinical evidence of fetal well-being and ultrasound arguments, since we know in fact that there is a correlation between Doppler indices of cardiovascular function and perinatal mortality.

The flow to the systolic aortic isthmus may be a marker of systolic performance balance of both ventricles. An index of systolic flow velocities (ISI) has previously been described in a population of normal fetuses. Fetuses with IUGR, the velocities recorded in the aortic isthmus could be affected and the normal development of the ISI should be changed, because of the increase in placental resistance on one hand, and the gradual deterioration ventricular functions on the other one. Investigators hypothesize that the ISI index in the context of placental insufficiency could provide additional arguments on the extraction timing, the prognosis and the fetal extraction mode to severe hypoxia.

The strategy evaluates the feasibility of measuring the ISI index on Doppler systolic flow in the aortic isthmus in the follow-up by ultrasound of the fetus with IUGR due to placental insufficiency.

The ISI is obtained from this flow by calculating the ratio of the minimum systolic velocity (called Nadir) on the peak systolic velocity (called Peak) or Nadir / Peak. The fetal extraction decision (birth) will be taken, blinded the outcome of the ISI, following the protocol of national recommendations for the management of fetuses with IUGR.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Gestational age determined by ultrasound dating of the first quarter
  • IUGR group: estimated fetal weight <10th percentile associated with
  • An abnormal umbilical artery Doppler with pulsatility index >95th percentile
  • OR a confirmation of placental vascular disease by histological examination
  • CONTROL group: non IUGR fetuses for gestational age (normal for weight, Doppler, and structural analyse)

排除标准

  • Twin or multiple pregnancy,
  • Fetal weight> 10th percentile
  • Presence of fetal infection
  • Structural fetal anomaly or fetal chromosomal abnormality

结局指标

主要结局

Compare the evolution of the values of the ISI in the fetus with IUGR relative to those of fetuses without IUGR fetuses for the same gestational age

时间窗: Up to 3 months

次要结局

  • Assess the feasibility of the Doppler and the measure of the parameter(Up to 3 months)
  • Compare the reproducibility of the measurement between sonographers with different levels of expertise(Up to 3 months)
  • Estimate the association between ISI index and perinatal mortality and the performance of the ISI in predicting perinatal mortality(Up to 3 months)

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (1)

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