Non-invasive Placental Chromosome Exploration of Intrauterine Growth Restriction

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Non-invasive Prenatal Testing of Placental Chromosomal Abnormalities in Fetus With Intrauterine Growth Restriction

Conditions
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Fetal Growth Retardation

Intervention / Treatment
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* Biological: Blood samples


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient having a fetus with intra-uterine growth restriction diagnosis below the 3rd percentile<br> | Biological: Blood samples<br>* Performed a 10 ml blood sample in each of the 200 patients included.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Inclusion date | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Inclusion date | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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trisomy, Non Invasive Prenatal Testing, cell- free DNA, placenta confined mosaic