Non-invasive Prenatal Diagnostic Validation Study

Completed

Conditions studied: Chromosome 13 Aneuploidy, Chromosome 18 Aneuploidy, Chromosome 21 Aneuploidy, Sex Chromosome Aberrations, Other Microdeletions

In brief

The primary purpose of this study is to collect maternal blood samples from pregnant women to develop a non-invasive prenatal diagnostic test based on fetal DNA isolated from maternal blood.

Key facts

Study ID

NCT01574781

Run by

Natera, Inc.

People needed

1781

Starts

2011-09-01

Expected to finish

2013-04-01

Last updated by the study team

2013-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Pregnant women who volunteer to donate blood sample during the first -, second- and/or third trimester
• The biological father of the child (or the father's brother and/or father) has to be at least 18 years of age and consent to his blood, buccal, or saliva collection.
• Pregnant women whose fetus was diagnosed with a chromosomal abnormality or genetic disorder by either amniocentesis or chorionic villus sampling who volunteer to donate a blood sample.
• Pregnant women who volunteer to donate a blood sample after their spontaneous miscarriage prior to undergoing D\&C procedure and who choose to utilize Natera's commercial products of conception molecular karyotyping service.
• Healthy volunteers (non-pregnant female and male) who volunteer to donate their blood sample.
• Umbilical cord blood or cheek swab/saliva samples from born children o Pregnant women who have participated in donating a blood sample during their pregnancy have the option to donate either an umbilical cord blood sample after child delivery, or a cheek swab or saliva sample from the born child using Natera's home kit.

You may not qualify if…

• Women carrying multiples

Where it is running

• Natera, Inc — Redwood City, California, United States

Full record on ClinicalTrials.gov

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