Clinical trial

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

Name
CHUBX 2021/12
Description
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.
Trial arms
Trial start
2021-10-05
Estimated PCD
2024-10-05
Trial end
2024-10-05
Status
Recruiting
Treatment
Blood samples
Performed a 10 ml blood sample in each of the 200 patients included.
Arms:
Patient having a fetus with intra-uterine growth restriction diagnosis below the 3rd percentile
Size
300
Primary endpoint
Determine the presence or absence of chromosomal abnormality in the plasma sample. studied.
Inclusion date
Eligibility criteria
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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'whole blood sample'}, 'enrollmentInfo': {'count': 300, 'type': 'ESTIMATED'}}
Updated at
2023-11-08

1 organization

1 product

1 indication