Validate Non-invasive Prenatal Tests for the Detection of Chromosomal Abnormalities

Launched by CERBAXPERT · Nov 8, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new non-invasive prenatal test (NIPT) that aims to detect potential chromosomal abnormalities in unborn babies. It is designed for pregnant women who may be at risk for these abnormalities and are already receiving routine prenatal care. The goal of the study is to collect samples and information that will help develop and validate this new testing method, making it safer and more reliable for expectant mothers.

To participate in this trial, women must be between 18 and 50 years old and between 10 and 40 weeks pregnant. They should already have some information about their baby's sex and, ideally, results from previous tests confirming their baby's health. Participants may need to provide a sample of their blood, which will be used to help develop the test. It's important to note that certain conditions, like recent blood transfusions or specific health issues, may prevent someone from joining the study. If you choose to participate, you'll be contributing to important research that could benefit many future families.

Gender

FEMALE

Eligibility criteria

• • Inclusion criteria
• • 1. Pregnant woman between 10 and 40 weeks of pregnancy 2. Gestational age at time of collection of the known sample 3. Maternal age 18-50 years 4. Sex of the fetus or newborn known (confirmed by doctor or karyotype) 5. Number of known fetuses 6.a) for affected samples: result of the karyotype available 6.b) for unaffected samples: preferably, result of the available karyotype; A secondarily negative NIPT result associated with a doctor's confirmation of the delivery of a healthy baby.
• • 7. Have a diagnostic result (such as amniocentesis or CVS) available if NIPT is positive 8. Patients Affiliated to a social security scheme or entitled to.
• • Non-inclusion criteria
• • 1. Confirmed mosaic sample
• • 2. Confirmed maternal mosaicism
• • 3. Recent maternal blood transfusion known
• • 4. Patient who received an organ transplant
• • 5. Patient who underwent surgery
• • 6. Patient on immunotherapy or stem cell therapy and/or other maternal malignancy
• • 7. Patient already included in the study during pregnancy
• • 8. Patient under guardianship or curatorship or safeguard of justice