Whole Blood Specimen Collection From Pregnant Subjects

NCT02430584 — Unknown, 5000 participants, Progenity, Inc.

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  
RegistryNCT02430584
StatusUnknown
Study typeObservational
Enrollment5000 (Estimated)
SponsorProgenity, Inc. (Industry)
ConditionsDown Syndrome, Edwards Syndrome, Patau Syndrome, Klinefelter Syndrome, Turner Syndrome, DiGeorge Syndrome, Perinatal Infections
InterventionsObservational - no intervention (Other)
Datesstart 2015-03-01, primary completion 2021-03-01 (estimated), completion 2021-05-01 (estimated), first posted 2015-04-30, last updated 2020-09-17
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Down Syndrome All trials for Edwards Syndrome All trials of Observational - no intervention

-Summary

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

Expand all sections  ·  Collapse all

+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.

+Arms and interventions

  • Observational - no intervention (Other)

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: Female, ages: 18 Years to any, accepts healthy volunteers

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)

FacilityCityCountryStatus
Regional Obstetrical ConsultantsChattanooga, TennesseeUnited States