Non-invasive Placental Chromosome Exploration of Intrauterine Growth Restriction

University Hospital, Bordeaux300 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Fetal Growth Retardation

Interventions

Blood samplesBIOLOGICAL

Performed a 10 ml blood sample in each of the 200 patients included.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, France

RECRUITING

Hôpital Antoine Béclère

Clamart, France

NOT_YET_RECRUITING

CHU Toulouse

Toulouse, France

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

Determine the presence or absence of chromosomal abnormality in the plasma sample. studied.

The result will be expressed in presence or absence of chromosomal abnormality such as trisomy, monosomy, deletion or duplication. The result will be compared with the fetal chromosome analysis carried out concomitantly on liquid amniotic as part of the treatment: if the analysis on Liquid Amniotic shows the same anomaly, it means that it is a fetal abnormality, if the Liquid Amniotic test is normal, it means that it is most likely an abnormality placental chromosome.

Time frame: Inclusion date

Secondary Outcomes

Determine the proportion of chromosomal placental etiology in Intrauterine Growth Restriction.

Proportion will be described in terms of percentage counts and 95% confidence interval depending on the test Fisher's exact (p \<0.05)

Time frame: Inclusion date

Central Contacts

Caroline THAMBO

CONTACT

05 56 79 59 52 caroline.rooryck-thambo@chu-bordeaux.fr

Virginie RACLET

CONTACT

05 56 79 59 52 virginie.raclet@chu-bordeaux.fr

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.