Genetic Disease, Pregnancy Related, Prenatal Screening
Conditions
Brief summary
The aim of this clinical study is the evaluation of clinical performance of a cell-based non-invasive test technology for fetal aneuploidies and segmental imbalances detection in a high-risk pregnancies population.
Interventions
Blood sampling
Sponsors
Menarini Biomarkers Singapore
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant has a viable singleton or twin pregnancy * Women who have already been selected by their treating physician to undergo an invasive fetal diagnostic procedure * Participant is at least 18 years old and can provide informed consent
Exclusion criteria
* Unable to provide informed consent * Prenatal diagnosis of clinical Chorioamnionitis * Intake of drugs or exposure to teratogenic agents * Infections that carry a risk of vertical transmission * Known maternal viral diseases: HIV and HCV, HBV
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fetal chromosomal abnormalities detection in circulating fetal cells, | 2 year | Evaluation of clinical performance of a cell-based technology for fetal chromosomal abnormalities detection in circulating fetal cells, using maternal blood samples from a population of high-risk pregnancies undergoing clinically indicated fetal diagnostic procedures. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of suitable fetal cells | 2 year | Determination, for each participant sample, of the number of intact fetal cells recovered that are suitable for downstream analysis. |
| Fetal sex assessment | 2 year | Early, non-invasive fetal sex assessment |
Countries
Italy
Contacts
Primary ContactChiara Bolognesi
Backup ContactAnna Doffini
Outcome results
None listed