Automated assessment of fetal heart function in babies with heart diseases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This international multicentre observational cohort study aims to evaluate automated fetal cardiac function parameters in healthy infants compared to those diagnosed with congenital heart defects. Participants will undergo two echocardiographic assessments during specific gestational weeks to monitor cardiac function over time. The study seeks to determine if significant differences exist between the two groups and whether these parameters can enhance the predictive value of cardiovascular profiles for predicting hydrops. Data will be collected and stored securely for future analysis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Inclusion criteria for the CHD Group are as follows: singleton pregnancies; gestational age between 19+6 and 36+6 weeks gestation, determined by the last menstrual period and confirmed by first trimester ultrasound; isolated congenital cardiac anomaly diagnosed.
* Inclusion criteria for the Control Group are as follows: singleton pregnancies; gestational age between 19+6 and 27+6 weeks gestation, determined by the last menstrual period and confirmed by first trimester ultrasound; no congenital cardiac anomaly diagnosed

Exclusion Criteria common to the 2 groups (Cases and Controls):

* 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

Where it's running

• Royal Hospital for Women
  Sydney, New South Wales, Australia Recruiting
• Sheba Medical Center
  Tel Aviv, Israel Not yet recruiting
• San Salvatore Hospital L'Aquila
  L’Aquila, Italy Not yet recruiting
• Vittore Buzzi Children's Hospital
  Milan, Italy Not yet recruiting
• Institute for Maternal and Child Health IRCCS Burlo Garofolo
  Trieste, Italy Not yet recruiting
• Centre Hospitalier de Mayotte
  Mamoudzou, Mayotte Not yet recruiting

Study contacts

• Principal investigator: Anna Erenbourg, MD — The University of New South Wales
• Study coordinator: Anna Erenbourg, MD
• Email: a.erenbourg@unsw.edu.au
• Phone: +61423879866

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.