Whole Blood Specimen Collection From Pregnant Subjects

Status unconfirmed

Conditions studied: Down Syndrome, Edwards Syndrome, Patau Syndrome, Klinefelter Syndrome, Turner Syndrome, DiGeorge Syndrome, Perinatal Infections

In brief

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

Key facts

Study ID

NCT02430584

Run by

Progenity, Inc.

People needed

5000

Starts

2015-03-01

Expected to finish

2021-05-01

Last updated by the study team

2020-09-17

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

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

Where it is running

• Regional Obstetrical Consultants — Chattanooga, Tennessee, United States

Full record on ClinicalTrials.gov

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