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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient having a fetus with intra-uterine growth restriction diagnosis below the 3rd percentile |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood samples | Biological | Performed a 10 ml blood sample in each of the 200 patients included. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Childbearing women who:
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having a fetus with IUGR diagnosis below the 3rd percentile (after reference medical ultrasound)
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Patient having a fetus with IUGR diagnosis below the 3rd percentile (after reference medical ultrasound)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire de Bordeaux | Recruiting | Bordeaux | France |
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| ID | Term |
|---|---|
| D005317 | Fetal Growth Retardation |
| D014314 | Trisomy |
| ID | Term |
|---|---|
| D005315 | Fetal Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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whole blood sample
| Hôpital Antoine Béclère | Not yet recruiting | Clamart | 92140 | France |
|
| CHU Toulouse | Not yet recruiting | Toulouse | 31059 | France |
|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006130 | Growth Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000782 | Aneuploidy |
| D002869 | Chromosome Aberrations |
| D058674 | Chromosome Duplication |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |