CompletedNot Applicable

Clinical Evaluation of the SEQureDx T21 Test In High Risk Pregnancies

United States3,062 participantsStarted 2012-03

Plain-language summary

Whole blood samples will be collected from high-risk pregnant women to validate the clinical performance of the SEQureDx Trisomy 21 Test.

Who can participate

Age range18 Years – 60 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: * Pregnant woman 18 years of age or older at 10 - 22 weeks gestation inclusive * Subject has one or more high risk indicator for fetal chromosome 21 aneuploidy * Subject provides signed and dated informed consent * Subject agrees to provide a whole blood sample Exclusion Criteria: * Fetal demise at the time of the blood draw * Previous specimen donation under this protocol

What they're measuring

Clinical Assay Performance

Timeframe: Performance of the assay will be based upon a single blood sample collected during the only study visit from a high risk pregnancy prior to the subject undergoing an invasive procedure (amniocentesis or CVS) to confirm fetal karyotype.

Trial details

NCT IDNCT01555346

SponsorSequenom, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2014-10

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