NCT06705543 Antenatal Investigation of Fetuses With Complex Congenital Heart Defects Using multiOMICS
| NCT ID | NCT06705543 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Bordeaux |
| Condition | Congenital Heart Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-04-01 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Caroline ROORYCK-THAMBO, PROF
PRINCIPAL INVESTIGATOR
University Hospital, Bordeaux
Frequently Asked Questions
Who can join the NCT06705543 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Congenital Heart Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06705543 currently recruiting?
Yes, NCT06705543 is actively recruiting participants. Contact the research team at caroline.rooryck-thambo@chu-bordeaux.fr for enrollment information.
Where is the NCT06705543 trial being conducted?
This trial is being conducted at Bordeaux, France, Nantes, France.
Who is sponsoring the NCT06705543 clinical trial?
NCT06705543 is sponsored by University Hospital, Bordeaux. The principal investigator is Caroline ROORYCK-THAMBO, PROF at University Hospital, Bordeaux. The trial plans to enroll 40 participants.