Non-invasive Prenatal Diagnostic Validation Study (NCT01574781) | Clinical Trial Compass
CompletedNot Applicable
Non-invasive Prenatal Diagnostic Validation Study
United States1,781 participantsStarted 2011-09
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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.
Exclusion Criteria:
* Women carrying multiples
What they're measuring
1
Fetal chromosome abnormality from a maternal plasma sample
Timeframe: From date of initial blood draw until the date of pregnancy end (miscarriage/termination) or time of birth, whichever came first, assessed up to 10 months