Automated Fetal Cardiac Function in Babies Affected by Heart Diseases
Automated Fetal Cardiac Function Parameters in Congenital Heart Disease
Anna Erenbourg
495 participants
May 1, 2023
OBSERVATIONAL
Summary
The goal of this international multicentre prospective observational cohort study with a nested case-control study is to test some automated fetal heart functional parameters in healthy babies compared to those affected by a congenital heart condition. The main questions it aims to answer are: * If there is a significant difference between the two populations of infants * Whether these parameters could significantly improve the predictive value of actual cardiovascular profile score to predict hydrops Participants will be offered two automated cardiac function assessments between 27+6 and 29+6 gestational weeks and between 34+6 and 36+6 weeks of gestation. Functional parameters will be compared between the two study groups and evaluated over time.
Eligibility
Exclusion Criteria7
- Fetuses whose mothers have comorbidities that have been proven to potentially affect cardiac function including:
- intrahepatic cholestasis
- pre-gestational and gestational diabetes
- preeclampsia
- growth restricted fetuses defined as estimated fetal weight or abdominal circumference <3rd percentile for GA
- Fetuses with other structural extracardiac anomalies at ultrasound examination
- Fetuses affected by any diagnosed genetic abnormalities
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Interventions
Evaluation of ultrasound parameters by automated algorithms. Ultrasound assessed parameters are: 1. Pulsed wave Doppler Modified Left and Right Myocardial performance indices 2. Spatio-temporal image correlation Tricuspid, Mitral and Septal Annular Plane Systolic Excursion
Locations(7)
View Full Details on ClinicalTrials.gov
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NCT05698277