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MatErnal BLood IS Source to Accurately Diagnose Fetal Aneuploidy (MELISSA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01122524
Recruitment Status : Completed
First Posted : May 13, 2010
Last Update Posted : October 10, 2011
Information provided by (Responsible Party):
Verinata Health, Inc.

Brief Summary:

The primary objective of this study is to determine the performance characteristics (sensitivity and specificity) of the Verinata Health Test to detect fetal Trisomy 21 (T21) compared to karyotype results obtained by amniocentesis or chorionic villus sampling (CVS).

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.

Condition or disease
Pregnant Women Prenatal Care

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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Prospective, Multi-center Observational Study With Blinded, Nested Case:Control Analyses to Evaluate the Performance of the Verinata Health Prenatal Aneuploidy Diagnostic Test
Study Start Date : June 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

Chromosomal Abnormality
Fetus affected by chromosomal abnormality
No Chromosomal Abnormality
Fetus not affected by chromosomal abnormality

Primary Outcome Measures :
  1. Classification of fetal status as affected or not affected for Trisomy 21 based on Artemis Health Test on maternal blood. [ Time Frame: 10 months ]

Biospecimen Description:

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Pregnant women undergoing chorionic villus sampling (CVS) or amniocentesis

Inclusion Criteria:

  • Age 18 years or older
  • 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:

- Invasive prenatal procedure (amniocentesis or CVS) performed prior to enrollment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01122524

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United States, California
Center for Fetal Medicine
Los Angeles, California, United States, 90048
San Francisco Perinatal Associates
San Francisco, California, United States, 94109
United States, Colorado
Women's Clinic of Northern Colorado
Fort Collins, Colorado, United States, 80524
United States, Florida
Visions Clinical Research
Boynton Beach, Florida, United States, 33437
OB/Gyn Specialists of the Palm Beaches
West Palm Beach, Florida, United States, 33401
United States, New Mexico
New Mexico Consortium for Perinatal Research
Albuquerque, New Mexico, United States, 87109
United States, New York
Winthrop University Hospital
Mineola, New York, United States, 11501
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18103
United States, Texas
The Women's Hospital of Texas
Houston, Texas, United States, 77054
United States, Virginia
Eastern Virginia Medical School
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Verinata Health, Inc.
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Study Director: Amy J Sehnert, MD Verinata Health, Inc.


Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Verinata Health, Inc. Identifier: NCT01122524    
Other Study ID Numbers: ART-0006
First Posted: May 13, 2010    Key Record Dates
Last Update Posted: October 10, 2011
Last Verified: October 2011
Keywords provided by Verinata Health, Inc.:
Trisomy 21
Additional relevant MeSH terms:
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Chromosome Aberrations
Pathologic Processes