Last updated on February 2018

Expanded Noninvasive Genomic Medical Assessment: The Enigma Study

Brief description of study

In January 2007, the American Congress of Obstetricians and Gynecologists (ACOG) revised its guidelines that now recommend physicians are ethically obligated to fully inform all pregnant women that screening for fetal chromosomal abnormalities including biochemical screening tests and invasive procedures such as CVS or amniocentesis is available, regardless of age. Further, it is entirely up to the patient to decide whether or not she wishes to be screened for fetal chromosomal abnormalities without judgment from the physician.

Noninvasive laboratory-developed tests (LDTs) that detect an abnormal amount of maternal and fetal DNA in an expectant mother's blood sample (known as circulating cell-free DNA) are now available. These LDTs have not been cleared or approved by the U.S. Food and Drug Administration (FDA). Although LDTs to date have not been subject to U.S. FDA regulation, certification of the laboratory is required under the Clinical Laboratory Improvement Amendments (CLIA) to ensure the quality and validity of the test.

To sample collection study will obtain whole blood specimens from pregnant subjects to be used for development of prenatal assays to assist in the screening for fetal genetic abnormalities, infectious and other diseases, and blood group typing through detection of circulating cell-free DNA extracted from maternal plasma.

Detailed Study Description

Eligible subjects will provide written informed consent after which basic demographic and clinical data will be collected.

Study procedures involve the collection of 50 mL of whole blood at one or more monthly clinic visits (25 days apart) from pregnant women (18 to 54 yrs of age) carrying a single fetus of 8 to 22 weeks of gestational age inclusive.

Clinical Study Identifier: NCT02787486

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Ravi Gunatilake, MD

Valley Perinatal
Scottsdale, AZ United States
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Monty Heinan, MD

Heinen Obstectrics & Gynecology
Eunice, LA United States
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Lisa Eng, DO

Newlife Wellness OBGYN
Brooklyn, NY United States
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Todd J. Adams, MD, MPH, ...

Lakeshore Women's Specialists
Mooresville, NC United States
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David B Schwartz, MD

Cincinnati Obgyn
Cincinnati, OH United States
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James D Kasten, MD, FACOG

James D. Kasten, M.D., Inc.
Norwalk, OH United States
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Charles David Adair, MD

Regional Obstetrical Consultants
Chattanooga, TN United States
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Nima Goharkhay, MD

Texas Maternal-Fetal Medicine
Webster, TX United States
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Recruitment Status: Open

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