Antenatal Investigation of Fetuses With Complex Congenital Heart Defects Using multiOMICS

Recruiting now · Not applicable

Conditions studied: Congenital Heart Disease

In brief

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.

Key facts

Study ID

NCT06705543

Run by

University Hospital, Bordeaux

People needed

40

Starts

2025-04-01

Expected to finish

2026-12-01

Last updated by the study team

2025-04-10

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• CHU de Bordeaux — Bordeaux, France (enrolling)
• CHU de Nantes — Nantes, France

Full record on ClinicalTrials.gov

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