Automated Fetal Cardiac Function in Babies Affected by Heart Diseases
Recruiting now
Conditions studied: Congenital Heart Defect, Cardiac Function
In brief
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.
Key facts
- Study ID
- NCT05698277
- Run by
- Anna Erenbourg
- People needed
- 495
- Starts
- 2023-05-01
- Expected to finish
- 2028-02-01
- Last updated by the study team
- 2024-12-10
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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 it is running
- Royal Hospital for Women — Sydney, New South Wales, Australia (enrolling)
- Sheba Medical Center — Tel Aviv, Israel
- San Salvatore Hospital L'Aquila — L’Aquila, Italy
- Vittore Buzzi Children's Hospital — Milan, Italy
- Institute for Maternal and Child Health IRCCS Burlo Garofolo — Trieste, Italy
- Centre Hospitalier de Mayotte — Mamoudzou, Mayotte
- Medical Center Ujastek — Krakow, Poland
Full record on ClinicalTrials.gov
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