Assessment of Cardiac Sparing in Fetal Hypoxia

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT03146507
Collaborator
(none)
137
1
30
4.6

Study Details

Study Description

Brief Summary

The fetal heart plays a central role in the adaptive mechanisms for hypoxemia and placental insufficiency. Longitudinal data on the hemodynamic sequence of the natural history of fetal growth restriction show that the umbilical artery and middle cerebral artery are the first variables to become abnormal . These arterial Doppler abnormalities are followed by abnormalities in the right cardiac diastolic indices, followed by the right cardiac systolic indices, and finally by both left diastolic and systolic cardiac indices .

Preserving the left systolic function as the last variable to become abnormal ensures an adequate left ventricular output , which supplies the cerebral and coronary circulations.This defence is contingent on the fetal cardiovascular system, which in late gestation adopts strategies to decrease oxygen consumption and redistribute the cardiac output away from peripheral vascular beds and towards essential circulations, such as those perfusing the brain.

Adding cardiac Doppler may improve management of the IUGR fetus(intrauterine growth retardation), Doppler ultrasound is valuable in defining the degree of cardiovascular compromise in at-risk pregnancies. The severity of fetal blood flow redistribution shows the degree of fetal adaptation and provides information on how long the pregnancy can be continued safely.

The aime of the study is assessment of cardiac output redistribution in fetal hypoxia by estimating relative right to left side cardiac output wich reflect cardiac sparing in (IUGR).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    137 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Doppler Echocardiography Assessment of Cardiac Sparing Effect in Fetal Hypoxia
    Actual Study Start Date :
    Aug 1, 2017
    Actual Primary Completion Date :
    Mar 1, 2019
    Actual Study Completion Date :
    Feb 1, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Relative cardiac output [15 minutes]

      Ratio between right side cardiac output to left side cardiac output

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. Singleton fetus with normal fetal anatomy documented on a detailed sonogram.

    2. Fetal abdominal circumference <5th percentile for gestational age.

    3. Evidence of placental insufficiency documented by an elevated umbilical artery pulsatility index (UA-PI) by reference ranges.

    Exclusion Criteria:
    1. evidence of fetal infection

    2. chorioamnionitis

    3. fetal anomalies

    4. 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:
    NCT03146507
    Other Study ID Numbers:
    • AU03
    First Posted:
    May 10, 2017
    Last Update Posted:
    Feb 18, 2020
    Last Verified:
    Feb 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 18, 2020