Actively Recruiting
Automated Fetal Cardiac Function in Babies Affected by Heart Diseases
Led by Anna Erenbourg · Updated on 2024-12-10
495
Participants Needed
7
Research Sites
248 weeks
Total Duration
On this page
Sponsors
A
Anna Erenbourg
Lead Sponsor
C
Centre Hospitalier de Mayotte
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Automated Fetal Cardiac Function in Babies Affected by Heart Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Singleton pregnancies
- Gestational age between 19 weeks 6 days and 36 weeks 6 days confirmed by last menstrual period and first trimester ultrasound (CHD group)
- Isolated congenital cardiac anomaly diagnosed (CHD group)
- Gestational age between 19 weeks 6 days and 27 weeks 6 days confirmed by last menstrual period and first trimester ultrasound (Control group)
- No congenital cardiac anomaly diagnosed (Control group)
You will not qualify if you...
- Mothers with comorbidities that may affect cardiac function including intrahepatic cholestasis, pre-gestational and gestational diabetes, or preeclampsia
- Growth restricted fetuses defined as estimated fetal weight or abdominal circumference less than 3rd percentile for gestational age
- Fetuses with other structural extracardiac anomalies detected on ultrasound
- Fetuses diagnosed with any genetic abnormalities
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Royal Hospital for Women
Sydney, New South Wales, Australia
Actively Recruiting
2
Sheba Medical Center
Tel Aviv, Israel
Not Yet Recruiting
3
San Salvatore Hospital L'Aquila
L’Aquila, Italy
Not Yet Recruiting
4
Vittore Buzzi Children's Hospital
Milan, Italy
Not Yet Recruiting
5
Institute for Maternal and Child Health IRCCS Burlo Garofolo
Trieste, Italy
Not Yet Recruiting
6
Centre Hospitalier de Mayotte
Mamoudzou, Mayotte
Not Yet Recruiting
7
Medical Center Ujastek
Krakow, Poland
Not Yet Recruiting
Research Team
A
Anna Erenbourg, MD
CONTACT
A
Alec W Welsh, MD PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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