Trials / Unknown
UnknownNCT02430584
Whole Blood Specimen Collection From Pregnant Subjects
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 5,000 (estimated)
- Sponsor
- Progenity, Inc. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
- Down Syndrome
- Edwards Syndrome
- Patau Syndrome
- Klinefelter Syndrome
- Turner Syndrome
- DiGeorge Syndrome
- Perinatal Infections
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Observational - no intervention |
Timeline
- Start date
- 2015-03-01
- Primary completion
- 2021-03-01
- Completion
- 2021-05-01
- First posted
- 2015-04-30
- Last updated
- 2020-09-17
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02430584. Inclusion in this directory is not an endorsement.