Not Yet RecruitingNot Applicable

Cell-based Non-invasive Prenatal Test Workflow

1,400 participantsStarted 2026-05-04

Plain-language summary

The aim of this study is to optimize a new non-invasive prenatal screening method based on the capture of fetal cells from maternal blood and to complete its development by obtaining maternal blood samples during the first trimester of pregnancy.

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. Informed consent signed before any study-specific procedures
✓. Pregnant women with singleton or twin pregnancy, at 8+0 - 14+6 week of gestation, aged ≥18 years
✓. No medical contraindication for collecting 30 ml blood sample

Exclusion criteria

✕. Unable to provide informed consent
✕. Known infections that carry a risk of vertical transmission
✕. Known maternal viral diseases: HIV and HCV, HBV

What they're measuring

cEVTs isolation rate

Timeframe: 24 months

Trial details

NCT IDNCT07566780

SponsorMenarini Silicon Biosystems

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-12-31

View on ClinicalTrials.gov More Pregnant Women trials