Whole Blood Specimen Collection From Pregnant Subjects

NCT02430584 | Unknown

• 1 other identifier: PRO-101-SAMPLES
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

To obtain whole blood specimens from pregnant subjects to be used for research and development and clinical validation studies of prenatal assays.

Conditions

Down Syndrome; Edwards Syndrome; Patau Syndrome; Klinefelter Syndrome; Turner Syndrome; DiGeorge Syndrome; Perinatal Infections

Outcome Measures

Primary Outcomes (1)

• Whole blood collection

  One or more monthly clinic visits (≥25 days apart) over 13 weeks

Interventions

Observational - no intervention OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

GENDER: Female ETHNICITY: All ethnicities RACE: All races AGE: Subjects 18 years of age or older

You may qualify if:

• 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:
• fetal gene and chromosome abnormalities
• congenital fetal infection
• known to possess irregular blood group antigens (subject or father of the baby)
• known to have some other condition amenable to noninvasive prenatal testing

You may not qualify if:

• Pregnancy is non-viable

Sponsors & Collaborators

• Progenity, Inc.: lead

Study Sites (1)

Regional Obstetrical Consultants

Chattanooga, Tennessee, 37403, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Down Syndrome; Trisomy 18 Syndrome; Trisomy 13 Syndrome; Klinefelter Syndrome; Turner Syndrome; DiGeorge Syndrome

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Sex Chromosome Disorders of Sex Development; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Sex Chromosome Disorders; Gonadal Disorders; Endocrine System Diseases; Hypogonadism; Gonadal Dysgenesis; 22q11 Deletion Syndrome; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Lymphatic Abnormalities; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypoparathyroidism; Parathyroid Diseases

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2015
• First Posted: April 30, 2015
• Study Start: March 1, 2015
• Primary Completion: March 1, 2021
• Study Completion: May 1, 2021
• Last Updated: September 17, 2020

Record last verified: 2020-09

Locations

US (1)