Taking people in FranceNo phase
Antenatal Investigation of Fetuses With Complex Congenital Heart Defects Using multiOMICS
Key facts
- Who runs it
- University Hospital, Bordeaux
- Where
- Bordeaux and Nantes, FranceSee the 2 sites
- Trial code
- Status
- Recruiting
- People taking part
- 40 people, planned
- Started
- 1 Apr 2025
- Expected to end
- Dec 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- multi-omics genetic analyses included exome
- multi-omics genetic analyses
- Record updated
- 10 April 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women only
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- 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)
Who cannot take part
- 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 in France
- CHU de BordeauxBordeaux, FranceContact: Caroline ROORYCK-THAMBO, PROFTaking people
- CHU de NantesNantes, FranceContact: Marie VINCENT, DRNot yet recruiting
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Congenital Heart Defects populationExisting treatment, for comparison
Treatment: multi-omics genetic analyses included exome
- control populationPlacebo, for comparison
Treatment: multi-omics genetic analyses
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 10 April 2025