Expanded Noninvasive Genomic Medical Assessment: The Enigma Study
Public ClinicalTrials.gov record NCT02787486. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Clinical Study to Evaluate the Relative Clinical Sensitivity, Specificity, and Performance of the a Laboratory Developed Test as a Screening Test for Fetal Chromosomal Aneuploidy, Infectious and Other Diseases, and RhD Genotyping in the General Population of Pregnant Women
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02787486
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 760 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 54 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2015
- Primary completion
- Aug 31, 2018
- Completion
- Aug 31, 2018
- Last update posted
- Aug 20, 2019
2015 – 2018
United States locations
- U.S. sites
- 8
- U.S. states
- 7
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Valley Perinatal | Scottsdale | Arizona | 85258 | — |
| Heinen Obstectrics & Gynecology | Eunice | Louisiana | 70535 | — |
| Newlife Wellness OBGYN | Brooklyn | New York | 11220 | — |
| Lakeshore Women's Specialists | Mooresville | North Carolina | 28117 | — |
| Cincinnati Obgyn | Cincinnati | Ohio | 45219 | — |
| James D. Kasten, M.D., Inc. | Norwalk | Ohio | 44857 | — |
| Regional Obstetrical Consultants | Chattanooga | Tennessee | 37403 | — |
| Texas Maternal-Fetal Medicine | Webster | Texas | 77598 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02787486, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 20, 2019 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02787486 live on ClinicalTrials.gov.