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Non-invasive Placental Chromosome Exploration of Intrauterine Growth Restriction (DPNI-RCIU)

U

University Hospital of Bordeaux

Status

Enrolling

Conditions

Fetal Growth Retardation

Treatments

Biological: Blood samples

Study type

Observational

Funder types

Other

Identifiers

NCT05023161
CHUBX 2021/12

Details and patient eligibility

About

The objective of this project is the non-invasive prenatal detection of placenta-limited aneuploidies, in patients whose fetuses have a intrauterine growth restriction below 3rd percentile, in parallel with an amniocentesis.

This study will allow the chromosomal study of the placenta in pregnant women whose genetic prenatal diagnosis, made by amniocentesis, does not allow exploring the placental causes of fetal RCIU.

Full description

Placental chromosomal aneuploidies will be detected by high-throughput whole genome sequencing of non-cellular DNA present in maternal plasma during pregnancy.

The study of the cfDNA will be carried out from a blood sample with the automated solution VERISEQ NIPT (Illumina) using the software illumina VeriSeq v2, allowing the detection of all chromosomal abnormalities.

Enrollment

300 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • over 18 years old,
  • treated in the DDIANE fetal medicine centre at the Bordeaux University Hospital,
  • having a fetus with IUGR diagnosis below the 3rd percentile (after reference medical ultrasound),
  • from 16 weeks of amenorrhea or more,
  • accepting an Invasive Prenatal Diagnosis by amniocentesis with array comparative genomic hybridization

Exclusion criteria

Childbearing women who:

  • do not accept a non-invasive prenatal diagnosis (amniocentesis)
  • have a fetus with non-isolated IUGR (associated with other ultrasound signs)
  • do not consent to participate in the research protocol

Trial design

300 participants in 1 patient group

Patient having a fetus with intra-uterine growth restriction diagnosis below the 3rd percentile
Treatment:
Biological: Blood samples

Trial contacts and locations

3

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Central trial contact

Caroline THAMBO; Virginie RACLET

Data sourced from clinicaltrials.gov

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