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Completed

NCT Number: NCT03108040

Evaluation of Fetal Cardiac Function and Vascular Hemodynamics in Intrauterine Growth Restriction

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 .

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Key information

Conditions

Fetal Hypoxia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Hypoxia Pathological Conditions, Signs and Symptoms Pregnancy Complications Signs and Symptoms Signs and Symptoms, Respiratory Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Advanced Fetal Cair Unit - Assiut University

Asyut, Egypt

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Myocardial performance index

    Time frame: 5 minutes

    Ratio between isovolumetric time to ejection time

  2. 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

  3. Cerebroplacental ratio

    Time frame: 5 minutes

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

  4. 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

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Apr 11, 2017
Registry last updated
Feb 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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