Trials / Unknown
UnknownNCT05023161
Non-invasive Placental Chromosome Exploration of Intrauterine Growth Restriction
Non-invasive Prenatal Testing of Placental Chromosomal Abnormalities in Fetus With Intrauterine Growth Restriction
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 300 (estimated)
- Sponsor
- University Hospital, Bordeaux · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- —
Summary
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
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Blood samples | Performed a 10 ml blood sample in each of the 200 patients included. |
Timeline
- Start date
- 2021-10-05
- Primary completion
- 2024-10-05
- Completion
- 2024-10-05
- First posted
- 2021-08-26
- Last updated
- 2023-11-08
Locations
3 sites across 1 country: France
Source: ClinicalTrials.gov record NCT05023161. Inclusion in this directory is not an endorsement.