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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
1,500
Blood sampling
Fondazione IRCCS Ca' Granda-Policlinico di Milano Ospedale Maggiore
Milan, Italy
RECRUITINGFetal chromosomal abnormalities detection in circulating fetal cells,
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.
Time frame: 2 year
Number of suitable fetal cells
Determination, for each participant sample, of the number of intact fetal cells recovered that are suitable for downstream analysis.
Time frame: 2 year
Fetal sex assessment
Early, non-invasive fetal sex assessment
Time frame: 2 year
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