RecruitingNCT05698277

Automated Fetal Cardiac Function in Babies Affected by Heart Diseases

Automated Fetal Cardiac Function Parameters in Congenital Heart Disease


Sponsor

Anna Erenbourg

Enrollment

495 participants

Start Date

May 1, 2023

Study Type

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

Sex: FEMALEMin Age: 18 Years

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

DIAGNOSTIC_TESTAutomated fetal cardiac function evaluation

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)

Royal Hospital for Women

Sydney, New South Wales, Australia

Sheba Medical Center

Tel Aviv, Israel

San Salvatore Hospital L'Aquila

L’Aquila, Italy

Vittore Buzzi Children's Hospital

Milan, Italy

Institute for Maternal and Child Health IRCCS Burlo Garofolo

Trieste, Italy

Centre Hospitalier de Mayotte

Mamoudzou, Mayotte

Medical Center Ujastek

Krakow, Poland

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NCT05698277