Study of Automated Fetal Heart Function in Pregnancies with and without Congenital Heart Defects

What this Trial Is About

Researchers are studying automated fetal heart function parameters to see if they differ between healthy babies and those with congenital heart disease. This international multicenter observational study aims to find out if these automated measurements can better predict heart complications like hydrops compared to current cardiovascular scores. The study focuses on pregnancies with and without fetal heart defects to compare cardiac function over time. Participants will have two fetal cardiac function ultrasound scans one between 27 weeks and 29 weeks plus 6 days of pregnancy, and another between 34 weeks and 36 weeks plus 6 days. These scans use both clinical and advanced research ultrasound systems to capture detailed heart measurements, including heart size, valve function, blood flow, and contractility. The study collects images and data securely and follows participants until delivery and hospital discharge. During the study, women will undergo standard pregnancy ultrasounds alongside research scans assessing various heart function parameters. Researchers will analyze these detailed images and functional data to compare healthy and affected fetuses. They will also evaluate if adding automated measures improves prediction of complications like hydrops. Data confidentiality is maintained, and results will be published while protecting patient privacy. The entire pregnancy period is observed, with data collected at two specific gestational windows.

Automated Fetal Cardiac Function in Babies Affected by Heart Diseases