Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To obtain whole blood specimens from pregnant subjects to be used for research and development and clinical validation studies of prenatal assays.
This sample collection protocol allows for the identification, recruitment, and participation in women who are pregnant and are known to:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational - no intervention | Other |
| Measure | Description | Time Frame |
|---|---|---|
| Whole blood collection | One or more monthly clinic visits (≥25 days apart) over 13 weeks |
Not provided
Not provided
Inclusion Criteria:
Subject willing to provide consent to have up to 50 mL of whole blood collected at one or more monthly (≥25 days) clinic visits
Subject is pregnant carrying a singleton fetus of 10 to 26 weeks gestational age inclusive
Subject is 18 years of age or older
Subject is at an increased risk for one or more of the following:
Exclusion Criteria:
Not provided
Not provided
Not provided
GENDER: Female ETHNICITY: All ethnicities RACE: All races AGE: Subjects 18 years of age or older
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regional Obstetrical Consultants | Chattanooga | Tennessee | 37403 | United States |
Not provided
| ID | Term |
|---|---|
| D004314 | Down Syndrome |
| D000073842 | Trisomy 18 Syndrome |
| D000073839 | Trisomy 13 Syndrome |
| D007713 | Klinefelter Syndrome |
| D014424 | Turner Syndrome |
| D004062 | DiGeorge Syndrome |
| ID | Term |
|---|---|
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Study will collect up to 50 mL of whole blood at one or more monthly clinic visits (≥25 days apart) from pregnant women carrying a single fetus of 10 to 26 weeks of gestational age
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D058533 | Sex Chromosome Disorders of Sex Development |
| D012734 | Disorders of Sex Development |
| D014564 | Urogenital Abnormalities |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D025064 | Sex Chromosome Disorders |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D007006 | Hypogonadism |
| D006059 | Gonadal Dysgenesis |
| D058165 | 22q11 Deletion Syndrome |
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D009140 | Musculoskeletal Diseases |
| D044148 | Lymphatic Abnormalities |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007011 | Hypoparathyroidism |
| D010279 | Parathyroid Diseases |