TerminatedNot Applicable

Clinical Performance of the MaterniT21 PLUS LDT in Multiple Gestation Pregnancies

Stopped: Slow enrollment of eligible subjects

United States50 participantsStarted 2014-08

Plain-language summary

This study will evaluate the clinical performance of massively parallel sequencing (MPS) using the MaterniT21 PLUS LDT in the detection of fetal aneuploidy in circulating cfDNA extracted from a maternal blood sample obtained from women pregnant with a multiple gestation who were at increased risk for fetal aneuploidy.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subject was pregnant with a multiple gestation and received NIPT with the MaterniT21 PLUS LDT and a valid test result is available; * Subject was 18 years of age or older at the time of NIPT; * Subject provides signed and dated informed consent in English; Exclusion Criteria: * Subjects' treating physician is not located in the United States.

What they're measuring

Clinical Performance (Sensitivity/Specificity) of MaterniT21 PLUS LDT Assay

Timeframe: Subjects contacted within 3 years after pregnancy is completed

Trial details

NCT IDNCT02226315

SponsorSequenom, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2015-09

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