CompletedNot Applicable

Clinical Performance of NIPT in Multiple Gestation Pregnancies

United States2,000 participantsStarted 2020-03-01

Plain-language summary

This study plans to evaluate the clinical performance of the MaterniT21 PLUS and/or GENOME Laboratory Developed Test, in the detection of fetal trisomy 21 in circulating cell-free DNA extracted from maternal blood samples obtained from women pregnant with a twin gestation.

Who can participate

Age range18 Years

SexFEMALE

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Inclusion Criteria: * subject pregnant with a multiple gestation and received NIPT from Sequenom Laboratories; * subject was 18 or older at the time of NIPT Exclusion Criteria: * none

What they're measuring

Determination of sensitivity of NIPT detection of trisomy 21 among a population of women with twin gestations.

Timeframe: time from maternal blood draw to delivery

Determination of specificity of NIPT detection of trisomy 21 among a population of women with twin gestations.

Timeframe: time from maternal blood draw to delivery

Trial details

NCT IDNCT04488393

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-11-15

View on ClinicalTrials.gov More Trisomy 21 in Fetus trials