Whole Blood Specimen Collection From Pregnant Subjects

• Conditions: Down Syndrome; Patau Syndrome; DiGeorge Syndrome; Turner Syndrome; Edwards Syndrome; Klinefelter Syndrome; Perinatal Infections

• Registration Number: NCT02430584
• Lead Sponsor: Progenity, Inc.

Brief Summary

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

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 Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-04-27
• Study First Submitted QC: 2015-04-29
• Study First Posted: 2015-04-30
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-15
• Last Update Posted: 2020-09-17
• Primary Completion: 2021-03
• Study Completion: 2021-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 5000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Whole blood collection	One or more monthly clinic visits (≥25 days apart) over 13 weeks

Trial Locations

Locations (1)

Regional Obstetrical Consultants; 🇺🇸 Chattanooga, Tennessee, United States