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Clinical Evaluation of the SEQureDx Trisomy Test in Low Risk Pregnancies

NCT01597063 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3333

Last updated 2016-04-20

No results posted yet for this study

Summary

Pregnant women with low risk indicators for fetal chromosomal aneuploidy will be enrolled. Study blood will be collected in the first or second trimester at a scheduled prenatal screening visit, processed to plasma, and stored frozen until analysis. Each pregnancy will be followed until delivery and the birth outcome recorded.

Conditions

  • Aneuploidy
  • Down Syndrome
  • Noninvasive Prenatal Screening

Interventions

DEVICE

SEQureDx Trisomy Test

Plasma samples obtained from maternal blood will be tested using the SEQureDx Trisomy Test, an in vitro diagnostic test that measures circulating cell-free fetal DNA. The test detects the relative quantity of chromosome 21, which is associated with trisomy 21.

Sponsors & Collaborators

  • Sequenom, Inc.

    lead INDUSTRY

Principal Investigators

  • Daniel Grossu, MD · Sequenom, Inc.

Eligibility

Min Age
18 Years
Max Age
34 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2014-02-28
Completion
2015-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01597063 on ClinicalTrials.gov