Whole Blood Specimen Collection From Pregnant Subjects

Sponsor

Progenity, Inc. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT02430584

Collaborator

(none)

5,000

Enrollment

Location

Anticipated Duration (Months)

67.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Down Syndrome Edwards Syndrome Patau Syndrome Klinefelter Syndrome Turner Syndrome DiGeorge Syndrome Perinatal Infections	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:

be at an increased risk for fetal genetic abnormalities
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.
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 Design

Study Type:

Observational

Anticipated Enrollment :

5000 participants

Observational Model:

Family-Based

Time Perspective:

Prospective

Official Title:

Whole Blood Specimen Collection From Pregnant Subjects

Actual Study Start Date :

Mar 1, 2015

Anticipated Primary Completion Date :

Mar 1, 2021

Anticipated Study Completion Date :

May 1, 2021

Outcome Measures

Primary Outcome Measures

Whole blood collection [One or more monthly clinic visits (≥25 days apart) over 13 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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