Whole Blood Specimen Collection From Pregnant Subjects

Progenity, Inc.5,000 enrolled

Overview

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: 1. be at an increased risk for fetal genetic abnormalities 2. be at increased risk for congenital fetal infection by virtue of being positive by initial screening tests, or are known to have an active infection during this pregnancy. 3. possess irregular blood group antigens (the subject or the father of the baby) and are therefore at increased risk for fetal sensitization during this pregnancy.

Study Type

OBSERVATIONAL

Enrollment

5,000

Conditions

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

Interventions

Observational - no interventionOTHER

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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: * 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 Exclusion Criteria: * Pregnancy is non-viable

Locations (1)

Regional Obstetrical Consultants

Chattanooga, Tennessee, United States

Outcomes

Primary Outcomes

Whole blood collection

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.