Noninvasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker
NCT ID: NCT00971334
Last Updated: 2012-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2502 participants
OBSERVATIONAL
2009-08-31
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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PRA Health Sciences
INDUSTRY
Sequenom, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Allan T Bombard, MD
Role: STUDY_DIRECTOR
Sequenom, Inc.
Locations
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University of South Alabama
Mobile, Alabama, United States
Grossmont Center for Clinical Research
La Mesa, California, United States
IGO
San Diego, California, United States
San Diego Perinatal Center
San Diego, California, United States
Women's Healthcare at Frost Street
San Diego, California, United States
Poway Womens Care
San Diego, California, United States
Visions Clinical Research
Boynton Beach, Florida, United States
University of Miami
Miami, Florida, United States
South Florida Perinatal Medicine
Miami, Florida, United States
Global Ob/Gyn Centers
Pembroke Pines, Florida, United States
Discovery Clinical Research
Sunrise, Florida, United States
Sheridan Clinical Research
Sunrise, Florida, United States
Fetal Diagnostic Institution of the Pacific
Honolulu, Hawaii, United States
Women's Clinic
Boise, Idaho, United States
Reproductive Genetics Institute
Chicago, Illinois, United States
Spectrum Health - Maternal Fetal Medicine
Grand Rapids, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
St Louis University
St Louis, Missouri, United States
Methodist Hospital
Omaha, Nebraska, United States
Cooper University Hospital
Camden, New Jersey, United States
Lyndhurst Gynecologic Associates
Winston-Salem, North Carolina, United States
Complete Healthcare for Women
Columbus, Ohio, United States
Clinical Trials of America
Eugene, Oregon, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Kingsport Perinatology
Kingsport, Tennessee, United States
Perinatal Research Center
Nashville, Tennessee, United States
Tenessee Maternal Fetal Medicine
Nashville, Tennessee, United States
Houston Perinatal Associates
Houston, Texas, United States
Centre Hospitalier Universitaire de Nantes
Nantes, , France
Hopital Cochin Port Royal
Paris, , France
Hopital Robert Debre
Paris, , France
Hopital Paule de Viguier - CHU Toulouse
Toulouse, , France
Centre Hospitalier Regional et Universitaire - Hopital Bretonneau
Tours, , France
Countries
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Other Identifiers
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SQNM-T21-202
Identifier Type: -
Identifier Source: org_study_id
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