MatErnal BLood IS Source to Accurately Diagnose Fetal Aneuploidy
NCT ID: NCT01122524
Last Updated: 2011-10-10
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
10000 participants
OBSERVATIONAL
2010-06-30
2011-10-31
Brief Summary
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Secondary objectives are to assess performance of the test to detect male gender (XY) and other less common aneuploidies (Trisomy 13 (T13), Trisomy 18 (T18), and Turner Syndrome (45, X)) compared to clinical fetal karyotype.
Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Chromosomal Abnormality
Fetus affected by chromosomal abnormality
No interventions assigned to this group
No Chromosomal Abnormality
Fetus not affected by chromosomal abnormality
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Clinically confirmed viable pregnancy at the time of enrollment
* Clinically determined gestational age between 8 wks, 0 days and 22 wks, 0 days
* Referred or planning to undergo CVS or amniocentesis procedure due to risk of fetal aneuploidy based on protocol-specified clinical indicators
* Able to provide consent for participation using language appropriate forms and consent process
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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Verinata Health, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Amy J Sehnert, MD
Role: STUDY_DIRECTOR
Verinata Health, Inc.
Locations
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Center for Fetal Medicine
Los Angeles, California, United States
San Francisco Perinatal Associates
San Francisco, California, United States
Women's Clinic of Northern Colorado
Fort Collins, Colorado, United States
Visions Clinical Research
Boynton Beach, Florida, United States
OB/Gyn Specialists of the Palm Beaches
West Palm Beach, Florida, United States
New Mexico Consortium for Perinatal Research
Albuquerque, New Mexico, United States
Winthrop University Hospital
Mineola, New York, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
The Women's Hospital of Texas
Houston, Texas, United States
Eastern Virginia Medical School
Norfolk, Virginia, United States
Countries
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References
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http://www.clinchem.org/cgi/content/abstract/clinchem.2011.165910
Bianchi DW, Prosen T, Platt LD, Goldberg JD, Abuhamad AZ, Rava RP, Sehnert AJ; MatErnal BLood IS Source to Accurately diagnose fetal aneuploidy (MELISSA) Study Group*. Massively parallel sequencing of maternal plasma DNA in 113 cases of fetal nuchal cystic hygroma. Obstet Gynecol. 2013 May;121(5):1057-1062. doi: 10.1097/AOG.0b013e31828ba3d8.
Bianchi DW, Platt LD, Goldberg JD, Abuhamad AZ, Sehnert AJ, Rava RP; MatErnal BLood IS Source to Accurately diagnose fetal aneuploidy (MELISSA) Study Group. Genome-wide fetal aneuploidy detection by maternal plasma DNA sequencing. Obstet Gynecol. 2012 May;119(5):890-901. doi: 10.1097/AOG.0b013e31824fb482.
Other Identifiers
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ART-0006
Identifier Type: -
Identifier Source: org_study_id