Antenatal Investigation of Fetuses With Complex Congenital Heart Defects Using multiOMICS

Sponsor
University Hospital, Bordeaux
Study ID
NCT06705543
Status
Recruiting
Apply to this trial

Conditions

  • Congenital Heart Disease

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • multi-omics genetic analyses included exome — GENETIC
    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
    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 Details

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 Dates

First listed
Nov 26, 2024
Start date
Apr 1, 2025
Status verified
Apr 2025
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Congenital Heart Defects population
  • Placebo Comparator: control population

Primary Outcome Measure

Cardiac malformations biomarkers [ Time Frame: Visit 1 : day 0 ]

Central Contacts

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