Automated assessment of fetal heart function in babies with heart diseases

Automated Fetal Cardiac Function Parameters in Congenital Heart Disease

This study is testing if new ways to check fetal heart function can help doctors understand heart problems in babies with congenital heart defects compared to healthy babies.

Quick facts

• Study type: Observational
• Enrollment: 495 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: The University of New South Wales (Academic / other)
• Locations: 7 sites (Sydney, New South Wales and 6 other locations)
• Trial ID: NCT05698277 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include pregnant individuals with singleton pregnancies at specified gestational ages, either with or without diagnosed congenital heart anomalies.

Not a fit: Patients with comorbidities affecting cardiac function or those with other structural extracardiac anomalies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved early detection and management of congenital heart defects in fetuses.

How similar studies have performed: Other studies have shown promise in using automated assessments for fetal cardiac function, suggesting potential for success in this approach.

Eligibility criteria

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 this trial is running

Sydney, New South Wales and 6 other locations

• 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)
• Medical Center Ujastek — Krakow, Poland (Not_yet_recruiting)

Study contacts

• Principal investigator: Anna Erenbourg, MD — The University of New South Wales
• Study coordinator: Anna Erenbourg, MD

Conditions Congenital Heart Defect; Cardiac Function; Congenital Heart Diseases; Fetal Cardiac Function