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Assessment of Cardiac Sparing in Fetal Hypoxia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03146507
Recruitment Status : Completed
First Posted : May 10, 2017
Last Update Posted : February 18, 2020
Sponsor:
Information provided by (Responsible Party):
Sief el eslam Ahmed Ali, Assiut University

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
Fetal Hypoxia

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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 : August 1, 2017
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : February 1, 2020



Primary Outcome Measures :
  1. Relative cardiac output [ Time Frame: 15 minutes ]
    Ratio between right side cardiac output to left side cardiac output



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

observational study conducted at academic perinatalcenter, Patients who give written consent to participate in the study undergo a uniform antenatal assessment protocol that includes umbilical artery (UA), middle cerebral artery (MCA) and ductus venosus (DV) Doppler ultrasound studies as well as detailed fetal doppler echocardiography

  • Criteria for study eligibility are:

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03146507


Locations
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Egypt
Advanced Fetal Cair Unit - Assiut University
Assiut, Egypt
Sponsors and Collaborators
Assiut University
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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    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fetal Hypoxia
Hypoxia
Signs and Symptoms, Respiratory
Signs and Symptoms
Fetal Diseases
Pregnancy Complications