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Clinical Trials in France / NCT06705543
Recruiting Not applicable

Antenatal Investigation of Fetuses With Complex Congenital Heart Defects Using multiOMICS

NCT06705543 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2025-04-01
Last updated
2025-04-10

Condition(s) studied

Congenital Heart Disease

Investigational drug(s) / intervention(s)

multi-omics genetic analyses included exomemulti-omics genetic analyses

multi-omics genetic analyses included exome: Genetic analysis will be carried out on amniotic fluid from the volume collected as part of the by obstetricians working in the fetal medicine unit. These genetic analyses will include : * Study of free RNA circulating in the LA, * Methylome study. * Trio exome study (parents-fetus).

multi-omics genetic analyses: Genetic analysis will be carried out on amniotic fluid from the volume collected as part of the by obstetricians working in the fetal medicine unit; These genetic analyses will include : * Study of free RNA circulating in the LA, * Methylome study.

Study summary

This study will use multiOMICS study on fetuses with complexe congenital heart defects (CHD) to identify etiological epigenetic factors of these cardiac malformations, related to environmental factors during pregnancy.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: Fetuses with congenital heart disease : * Pregnant women aged 18 and more * Single foetal pregnancy in which the foetus has a complex non-syndromic congenital heart defect, with no identified chromosomal abnormality, gene syndrome or infection. * Patient for whom the indication for amniocentesis has been accepted by the CPDPN and accepted by the couple/patient * Gestational age between 20 and 28 weeks' gestation. * Person affiliated to or benefiting from a social security scheme. * Free, informed and express consent (confirmed in writing) (at the latest on the day of inclusion and before any examination required by the research). Control Population for RNAseq and MéthlySeq * Pregnant women aged 18 and more * Patient in whom the indication for amniocentesis has been retained by the CPDPN and accepted by the couple/patient, for a non-malformative ultrasound anomaly (hyperechoic bowel, idiopathic hydramnios, increased risk of trisomy 21, agenesis of the OPN, suspected toxoplasmosis/CMV seroconversion), with no chromosomal anomaly, gene syndrome or infection identified. * Gestational age between 20 and 28 weeks' gestation. * Person affiliated to or benefiting from a social security scheme. * Free, informed and express consent (confirmed in writing) (at the latest on the day of inclusion and before any examination required by the research). Exclusion Criteria: For both populations (cases and controls) : * Female minors, * Patients not affiliated to the social security system, * Patients who do not understand French, * Patients under guardianship * Multiple pregnancies, or where the foetus has associated malformations

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
CHU de Bordeaux Bordeaux France Recruiting
CHU de Nantes Nantes France Not Yet Recruiting

More University Hospital, Bordeaux trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06705543 on ClinicalTrials.gov ↗ ← All trials in France