Actively Recruiting
Antenatal Investigation of Fetuses With Complex Congenital Heart Defects Using multiOMICS
Led by University Hospital, Bordeaux · Updated on 2025-04-10
40
Participants Needed
2
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying complex congenital heart defects (CHD) in fetuses to find epigenetic causes linked to environmental factors during pregnancy. These heart malformations have varied origins, with genetic causes identified in only a minority of cases, and environmental exposures possibly playing a role. The study aims to better understand how gene and environment interactions contribute to CHD using advanced multi-omics methods. The study involves genetic analyses on amniotic fluid collected during routine amniocentesis. These analyses include free RNA study, methylome profiling, and trio exome sequencing (parents and fetus). The research compares fetuses with complex non-syndromic CHD to controls with non-malformative anomalies to identify biomarkers and molecular mechanisms. The study period covers prenatal samples taken between 20 and 28 weeks of gestation. Participants will undergo amniocentesis for sample collection, followed by multi-omics analyses including exome, RNA sequencing, and methylation studies. Researchers will examine biomarkers related to cardiac malformations at the initial visit. Consent and social security affiliation are required. The study is non-randomized and includes ongoing monitoring of genetic and epigenetic markers to improve understanding of CHD causes. The total participation duration aligns with the prenatal period of 20 to 28 weeks gestation and data collection at visit 1.
CONDITIONS
Brief Title
Antenatal Investigation of Fetuses With Complex Congenital Heart Defects Using multiOMICS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women aged 18 and older
- Single fetal pregnancy with a complex non-syndromic congenital heart defect and no identified chromosomal abnormality, gene syndrome, or infection
- Indication for amniocentesis accepted by the CPDPN and the couple/patient
- Gestational age between 20 and 28 weeks
- Affiliated with or benefiting from a social security scheme
- Free, informed, and written consent obtained before any study examination
- Control group: pregnant women aged 18 and older with indication for amniocentesis due to non-malformative ultrasound anomaly and no identified chromosomal abnormality, gene syndrome, or infection
- Control group gestational age between 20 and 28 weeks
- Control group affiliated with or benefiting from a social security scheme
- Control group has free, informed, and written consent obtained before any study examination
You will not qualify if you...
- Female minors
- Not affiliated with a social security system
- Unable to understand French
- Under legal guardianship
- Multiple pregnancies
- Fetus with associated malformations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day procedure
Participants undergo amniocentesis to collect amniotic fluid for multi-omics genetic analyses, including exome, RNA, and methylome studies.
1 visit (in-person)
Duration - Up to 6 months
Participants are observed to evaluate biomarkers associated with cardiac malformations and to better understand the pathophysiological mechanisms linked to congenital heart defects.
Follow-up visits as scheduled by the study team
Trial Site Locations
Total: 2 locations
1
CHU de Bordeaux
Bordeaux, France, 33076
Actively Recruiting
2
CHU de Nantes
Nantes, France, 44093
Not Yet Recruiting
Research Team
C
Caroline ROORYCK-THAMBO, PROF
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here