Clinical Trial: Clinical Evaluation of the SEQureDx Trisomy Test in Low Risk Pregnancies

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: A Clinical Study to Evaluate the Relative Clinical Specificity Performance of the SEQureDx Trisomy Test in Pregnant Women at Low Risk for Fetal Chromosomal Aneuploidy

Brief 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.

Detailed Summary:
Sponsor: Sequenom, Inc.

Current Primary Outcome: Estimate the false positive rate of SEQureDx Trisomy 21 Test [ Time Frame: pregnancy outcome ]

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Sequenom, Inc.

Dates:
Date Received: May 9, 2012
Date Started: July 2012
Date Completion:
Last Updated: April 18, 2016
Last Verified: April 2016