Automated Fetal Cardiac Function in Babies Affected by Heart Diseases

Launched by ANNA ERENBOURG · Jan 15, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how the hearts of babies with congenital heart defects (a type of heart condition present at birth) function compared to healthy babies. Researchers want to find out if specific heart function measurements can help doctors predict potential complications, like a serious condition called hydrops, where excess fluid builds up in a baby's body. The study involves two groups: one group of babies diagnosed with a congenital heart defect and another group of healthy babies.

To participate, expectant mothers must be carrying a single baby and be within a specific range of pregnancy weeks. For the group with heart defects, pregnancies must be between 19 to 36 weeks, while healthy pregnancies should be between 19 to 27 weeks. Participants will have their babies' heart function assessed twice during the pregnancy. The goal is to gather important information about how heart problems can affect babies before they are born and improve predictions of health risks. If you are interested or think you might qualify, please talk to your healthcare provider for more information.

Gender

FEMALE

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