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

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT03108040
Collaborator
(none)
534
Enrollment
1
Location
32
Actual Duration (Months)
16.7
Patients Per Site Per Month

Study Details

Study Description

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 .

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    534 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Evaluation of Non Invasive Fetal Cardiac Functions and Fetal Arterial&Venous Doppler Study in Intrauterine Growth Restriction as Predictive Parameters of Perinatal Outcome
    Actual Study Start Date :
    May 10, 2017
    Actual Primary Completion Date :
    Jul 10, 2019
    Actual Study Completion Date :
    Jan 10, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Myocardial performance index [5 minutes]

      Ratio between isovolumetric time to ejection time

    2. Aortic isthmus flow index [5 minutes]

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

    3. Cerebroplacental ratio [5 minutes]

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

    4. Preload Index in inferior vena cava [5 minutes]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Advanced Fetal Cair Unit - Assiut University Assiut Egypt

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sief el eslam Ahmed Ali, Principal investigator, Assiut University
    ClinicalTrials.gov Identifier:
    NCT03108040
    Other Study ID Numbers:
    • AUN80
    First Posted:
    Apr 11, 2017
    Last Update Posted:
    Feb 18, 2020
    Last Verified:
    Feb 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:
    Fetal Growth Retardation
    Fetal Hypoxia
    Hypoxia

    Study Results

    No Results Posted as of Feb 18, 2020