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Clinical Trials/NCT03108040
NCT03108040
Completed
Not Applicable

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 site in 1 country534 target enrollmentMay 10, 2017
ConditionsFetal Hypoxia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fetal Hypoxia
Sponsor
Assiut University
Enrollment
534
Locations
1
Primary Endpoint
Cerebroplacental ratio
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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 .

Registry
clinicaltrials.gov
Start Date
May 10, 2017
End Date
January 10, 2020
Last Updated
6 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sief el eslam Ahmed Ali

Principal investigator

Assiut University

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

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

Outcomes

Primary Outcomes

Cerebroplacental ratio

Time Frame: 5 minutes

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

Preload Index in inferior vena cava

Time Frame: 5 minutes

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

Myocardial performance index

Time Frame: 5 minutes

Ratio between isovolumetric time to ejection time

Aortic isthmus flow index

Time Frame: 5 minutes

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

Study Sites (1)

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