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Not Yet Recruiting NCT05698277

Automated Fetal Cardiac Function in Babies Affected by Heart Diseases

Conditions: Congenital Heart Defect, Cardiac Function

Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: 1
Enrollment: 495
Sponsor: Anna Erenbourg

Location: Australia

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 infantsWhether 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 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 diagnosedExclusion 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 cholestasispre-gestational and gestational diabetespreeclampsiagrowth restricted fetuses defined as estimated fetal weight or abdominal circumference <3rd percentile for GAFetuses with other structural extracardiac anomalies at ultrasound examinationFetuses affected by any diagnosed genetic abnormalities

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05698277). StuddyBuddy aggregates publicly available trial information.