Noninvasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00971334

Enrollment

2502

Registered

2009-09-03

Start date

2009-08-31

Completion date

2011-12-31

Last updated

2012-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aneuploidy, Down Syndrome, Edwards Syndrome, Pregnancy

Keywords

Down Syndrome, Aneuploidy, Amniocentesis, CVS

Brief summary

The purpose of this study is to collect samples for the purpose of developing a prenatal aneuploid test using circulating cell free fetal (ccff) nucleic acid from blood samples from pregnant women who have a high-risk pregnancy undergoing invasive prenatal diagnosis by chorionic villus sampling (CVS) and/or genetic amniocentesis. The results of the ccff aneuploid test will be compared to the chromosomal analysis obtained via CVS or amniocentesis.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Subject is female * Subject is pregnant * Subject is 18 years of age or older * Subject provides a signed and dated informed consent * Subject agrees to provide a 30-50mL blood sample * Subject is at increased risk for Down syndrome or other aneuploidies (greater than or equal to 35 years of age at time of delivery, elevated risk by maternal serum markers including Triple, Quad and integrated test, fetal birth defects or markers identified by ultrasound or family history of aneuploidy). * Subject plans to undergo an amniocentesis and/or CVS procedure * Subject agrees that the FISH, karyotype, and/or QF-PCR results obtained via the invasive procedure will be provided

Exclusion criteria

* None

Countries

France, United States

Outcome results