NCT00847990CompletedNot Applicable
Non-Invasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Sequenom, Inc.
- Enrollment
- 5,000
- Locations
- 25
- Primary Endpoint
- Validate the prenatal aneuploidy LDT with blood samples from pregnant women who are undergoing invasive prenatal diagnosis
Study Overview
Brief Summary
The purpose of this study is to determine if a laboratory test developed by the Sequenom Center for Molecular Medicine (SCMM) that uses a new marker found in the mother's blood can better identify pregnancies that have a child with a chromosome abnormality such as Down syndrome (Trisomy 21), Edwards syndrome (Trisomy 18), or other chromosome abnormality.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject is willing to provide written informed consent
- •Pregnant female with singleton gestation 18 years of age or older
- •Subject agrees to provide a 20 to 30 mL venous blood sample
- •Subject is one of the following: A) currently scheduled to undergo an amniocentesis and/or CVS procedure, OR B) currently in the first trimester of pregnancy and planning to undergo an amniocentesis in the second trimester
- •Subject will receive results of a genetic analysis that includes evaluation of the fetus for aneuploidy
Exclusion Criteria
- •Subject lacks the capacity to provide informed consent
- •Twins, triplets or other multiple gestation
Outcomes
Primary Outcomes
Validate the prenatal aneuploidy LDT with blood samples from pregnant women who are undergoing invasive prenatal diagnosis
Time Frame: During the 1st and 2nd trimester of pregnancy
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (25)
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