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Non-Invasive Determination of Fetal Chromosome Abnormalities

Conditions
Patau Syndrome (Trisomy 13)
Down Syndrome (Trisomy 21)
Edward's Syndrome (Trisomy 18)
Klinefelter Syndrome (47, XXY)
and Other Chromosome
Abnormalities.
Registration Number
NCT00891852
Lead Sponsor
Lenetix Medical Screening Laboratory
Brief Summary

The overall significance of this study is to develop a laboratory developed test (LDT) to use a new marker in the maternal blood to better identify pregnancies that have a child with a chromosome abnormality such as Down syndrome (trisomy 21), Edward's syndrome (trisomy 18), Patau syndrome (trisomy 13), Klinefelter syndrome, (47, XXY), and other chromosome abnormalities. Accomplishing that task would reduce the need for invasive amniocentesis and CVS procedures.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
Female
Target Recruitment
1000
Inclusion Criteria
  • This study is only applicable to women who are between 8 and 30 weeks' gestation and who have been determined increased risk for fetal aneuploidy. In the interest of expediting and simplifying this study, the investigators want only women who have already decided to undergo second-trimester amniocentesis or CVS.
Exclusion Criteria
  • The only exclusion criteria are those mentioned.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (7)

Maryland Perinatal Associates

🇺🇸

Rockville, Maryland, United States

Atlantic Maternal Fetal Medicine

🇺🇸

Moristown, New Jersey, United States

Winthrop University Hospital

🇺🇸

Mineola, New York, United States

Elite Women's Health

🇺🇸

New Hyde Park, New York, United States

Columbia University, NewYork-Presbyterian Hospital

🇺🇸

New York, New York, United States

New York Perinatal Associates

🇺🇸

New York, New York, United States

UVM

🇺🇸

Burlington, Vermont, United States

Maryland Perinatal Associates
🇺🇸Rockville, Maryland, United States
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