UnknownNot Applicable

Study of Vanadis® NIPT for Non-invasive Prenatal Screening of Trisomies (T21, T18 and T13)

Italy1,200 participantsStarted 2018-06-20

Plain-language summary

This study will assess the feasibility of Vanadis NIPT for screening of T21, T18 and T13. The results obtained from Vanadis NIPT will be compared with the study site's current prenatal screening methods. The primary objectives are: 1) To assess the feasibility of Vanadis NIPT for screening of T21, T18 and T13 in the maternal healthcare setting, 2) To assess preliminary performance of Vanadis NIPT for screening of T21 in comparison to site's routine screening methods i.e. combined and integrated tests, and 3) To evaluate preliminary cost effectiveness of Vanadis NIPT use in different models. The secondary objective is to assess the feasibility of Vanadis NIPT regarding determination of fetal sex.

Who can participate

Age range18 Years – 55 Years

SexFEMALE

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Inclusion Criteria: * between the age of 18 and 55 years (inclusive) * ≥ 10+0 weeks gestation Exclusion Criteria: * Pregnant woman undergoing amniocentesis without any screening test result * Pregnant woman with previous severe hypotension episodes or other conditions that may complicate the blood sampling * Known maternal aneuploidy * Known maternal cancer * Invasive test (chorionic villus sampling or amniocentesis) performed before blood sampling for NIPT

What they're measuring

Assess preliminary performance of Vanadis NIPT for screening of T21 in comparison to site's routine screening methods i.e. combined and integrated tests

Timeframe: Three weeks

Trial details

NCT IDNCT03559374

SponsorPerkinElmer, Wallac Oy

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2020-04

View on ClinicalTrials.gov More Trisomy 21 trials