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临床试验/NCT03108040
NCT03108040已完成不适用

Evaluation of Non Invasive Fetal Cardiac Functions and Fetal Arterial&Venous Doppler Study in Intrauterine Growth Restriction as Predictive Parameters of Perinatal Outcome

Assiut University1 个研究点 分布在 1 个国家目标入组 534 人开始时间: 2017年5月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
534
试验地点
1
主要终点
Cerebroplacental ratio

研究概览

简要总结

Intrauterine growth restriction (IUGR) is one of the major contributors to perinatal mortality and morbidity and is characterized by complex hemodynamic changes involving placental and fetal arterial, cardiac and venous circulations .However, the temporal sequence of these modifications in relation to other hemodynamic changes of the fetal arterial and venous circulations is unknown.

The aim of this study was to evaluate cardiac function and other hemodynamic changes in a group of fetuses with IUGR and clinical impact on perinatal outcome .

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Singleton fetus with normal fetal anatomy documented a detailed sonogram.
  • Fetal abdominal circumference <5th percentile for gestational age.
  • Evidence of placental insufficiency documented by an elevated umbilical artery pulsatility index (UA-PI) by reference ranges.

排除标准

  • evidence of fetal infection
  • chorioamnionitis
  • fetal anomalies
  • abnormal fetal karyotype
  • patient withdrawal from the study and/or unavailability for follow-up.

结局指标

主要结局

Cerebroplacental ratio

时间窗: 5 minutes

cerebroplacental ratio = Rtio middle cerebral artery pulsatility index / umbilical artery pulsatility index

Preload Index in inferior vena cava

时间窗: 5 minutes

Preload Index in inferior vena cava = ratio of peak systolic velocity in atrial contraction /peak systolic velocity ventricular systole

Myocardial performance index

时间窗: 5 minutes

Ratio between isovolumetric time to ejection time

Aortic isthmus flow index

时间窗: 5 minutes

Aortic isthmus flow index = Ratio of (systolic velocity time integral+diastolic velocity time integral) / systolic velocity time integral

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sief el eslam Ahmed Ali

Principal investigator

Assiut University

研究点 (1)

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