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Non Syndromic Congenital Heart Defect and Array-CGH in Prenatal Diagnosis (CAPA)

R

Rennes University Hospital

Status

Completed

Conditions

Non Syndromic Congenital Heart

Study type

Observational

Funder types

Other

Identifiers

NCT02333097
2014-A01528-39

Details and patient eligibility

About

Comparative genomic hybridization (CGH)-based microarrays are now often used during pregnancy in case of fetal polymalformation in order to assess significant genomic alterations. However, it is not clear whether array-CGH provide a diagnostic utility in case of isolated congenital heart defect.

This is the first prospective study aiming at defining the right chromosomal screening when a fetal isolated congenital heart defect is identified by ultrasound.

Full description

Comparative genomic hybridization (CGH)-based microarrays are now often used during pregnancy in case of fetal polymalformation in order to assess significant genomic alterations. Up to now, in case of isolated heart defect, only fetal karyotype with FISH 22q11 was usually offered. However, micro deletions or duplications could not be identified elsewhere throughout the genome. Then, in case of fetal chromosomal micro-rearrangements, parents could not be fully informed for global and neurodevelopmental prognosis. To our knowledge, clear-cut study, to assess whether array-CGH provide a diagnostic utility in case of isolated congenital heart defect, don't exist.

After informed consent, 80 women will be enrolled during two years in 2 official prenatal diagnosis centers in France. This survey is assumed to identify at least 8% of unbalanced chromosomal abnormalities. This will be also compared with 22q11 rearrangements rate.

This is the first prospective study aiming at defining the right chromosomal screening when a fetal isolated congenital heart defect is identified by ultrasound.

Enrollment

78 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Pregnant woman over 18-year-old ;
  • Ongoing health insurance ;
  • Informed consent ;
  • Prenatal samples from amniotic fluid ;
  • Isolated congenital heart defect.

Exclusion criteria

  • Transposition of great arteries ;
  • Amniotic fluid sample refusal.

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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