Incidence and mortality trend of congenital heart disease at the global, regional, and national level, 1990-2017.
Weiliang Wu, Jinxian He, Xiaobo Shao
https://pubmed.ncbi.nlm.nih.gov/32502030Actively Recruiting
Led by Anna Erenbourg · Updated on 2024-12-10
495
Participants Needed
7
Research Sites
4 weeks
Total Duration
A
Anna Erenbourg
Lead Sponsor
C
Centre Hospitalier de Mayotte
Collaborating Sponsor
Researchers are studying automated fetal heart function parameters to see if they differ between healthy babies and those with congenital heart disease. This international multicenter observational study aims to find out if these automated measurements can better predict heart complications like hydrops compared to current cardiovascular scores. The study focuses on pregnancies with and without fetal heart defects to compare cardiac function over time. Participants will have two fetal cardiac function ultrasound scans: one between 27 weeks and 29 weeks plus 6 days of pregnancy, and another between 34 weeks and 36 weeks plus 6 days. These scans use both clinical and advanced research ultrasound systems to capture detailed heart measurements, including heart size, valve function, blood flow, and contractility. The study collects images and data securely and follows participants until delivery and hospital discharge. During the study, women will undergo standard pregnancy ultrasounds alongside research scans assessing various heart function parameters. Researchers will analyze these detailed images and functional data to compare healthy and affected fetuses. They will also evaluate if adding automated measures improves prediction of complications like hydrops. Data confidentiality is maintained, and results will be published while protecting patient privacy. The entire pregnancy period is observed, with data collected at two specific gestational windows.
CONDITIONS
Automated Fetal Cardiac Function in Babies Affected by Heart Diseases
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - Up to 8 weeks (from approximately 19 weeks + 6 days to 27 weeks + 6 days of gestation)
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit
Duration - From 27 weeks + 6 days to 36 weeks + 6 days of gestation
Participants undergo fetal cardiac function echocardiography to evaluate automated ultrasound parameters including cardiac morphology and function at two specified gestational age windows.
2 visits (in-person) between 27+6 - 29+6 weeks and 34+6 - 36+6 weeks gestation
Duration - Until delivery and hospital discharge
Participants are followed up until delivery and discharge of mother and neonate to collect pregnancy and birth outcomes information.
Follow-up through standard prenatal and postnatal care visits; visit schedule varies
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
A
Anna Erenbourg, MD
A
Alec W Welsh, MD PhD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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