Automated Fetal Cardiac Function in Babies Affected by Heart Diseases
NCT05698277
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
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
Conditions3
Browse More Trials
Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.
NCT05698277