NCT02430584UnknownNot Applicable
Whole Blood Specimen Collection From Pregnant Subjects
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Progenity, Inc.
- Enrollment
- 5,000
- Locations
- 1
- Primary Endpoint
- Whole blood collection
Study Overview
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:
- 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
- Observational Model
- Family Based
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Exclusion Criteria
- •Pregnancy is non-viable
Outcomes
Primary Outcomes
Whole blood collection
Time Frame: One or more monthly clinic visits (≥25 days apart) over 13 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Recruiting
Not Applicable
Specimen Collection From Pregnant Women at Increased Risk for Fetal AneuploidyDown SyndromeFetal AneuploidyNCT01429389Sequenom, Inc.2,000
Completed
Not Applicable
Collection of Whole Blood Specimens in Pregnant WomenPregnancy RelatedNCT03590678Illumina, Inc.3,000
Completed
Not Applicable
A Study Collecting Blood Samples From Pregnant Women to Aid in the Development of a Noninvasive Prenatal TestPregnancyNCT03620110Illumina, Inc.2,209
Active, not recruiting
Not Applicable
Prospective Collection of Whole Blood Specimens From RhD Negative Pregnant WomenRhesus D GenotypePregnancyNCT06690099Devyser Inc.500
Unknown
Not Applicable
Whole Blood Specimen Collection From Healthy SubjectsHealthy VolunteersNCT02797743Progenity, Inc.750