Whole Blood Specimen Collection From Pregnant Subjects

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

Study Overview

• Status: Unknown
• Conditions: Down Syndrome; DiGeorge Syndrome; Turner Syndrome; Klinefelter Syndrome; Edwards Syndrome; Patau Syndrome; Perinatal Infections
• Intervention / Treatment: Other: Observational - no intervention

Detailed Description

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 (Anticipated): 5000

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Regional Obstetrical Consultants

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Family-Based
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Whole blood collection	One or more monthly clinic visits (≥25 days apart) over 13 weeks

Collaborators and Investigators

• Sponsor: Progenity, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Anticipated): March 1, 2021
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: April 27, 2015
• First Submitted That Met QC Criteria: April 29, 2015
• First Posted (Estimate): April 30, 2015

Study Record Updates

• Last Update Posted (Actual): September 17, 2020
• Last Update Submitted That Met QC Criteria: September 15, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Lymphatic Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Endocrine System Diseases; Disease; Gonadal Disorders; Disorders of Sex Development; Urogenital Abnormalities; Congenital Abnormalities; Genetic Diseases, Inborn; Musculoskeletal Diseases; Parathyroid Diseases; Intellectual Disability; Heart Defects, Congenital; Cardiovascular Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Abnormalities, Multiple; Chromosome Disorders; Sex Chromosome Disorders; Sex Chromosome Disorders of Sex Development; 22q11 Deletion Syndrome; Lymphatic Abnormalities; Hypoparathyroidism; Hypogonadism; Gonadal Dysgenesis; Syndrome; Down Syndrome; Turner Syndrome; Trisomy 13 Syndrome; Trisomy 18 Syndrome; DiGeorge Syndrome; Klinefelter Syndrome
• Other Study ID Numbers: PRO-101-SAMPLES