Whole Blood Specimen Collection From Pregnant Subjects
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ClinicalTrials.gov Identifier: NCT02430584 |
Recruitment Status :
Active, not recruiting
First Posted : April 30, 2015
Last Update Posted : September 17, 2020
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Condition or disease | Intervention/treatment |
---|---|
Down Syndrome Edwards Syndrome Patau Syndrome Klinefelter Syndrome Turner Syndrome DiGeorge Syndrome Perinatal Infections | Other: Observational - no intervention |
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 Type : | Observational |
Estimated Enrollment : | 5000 participants |
Observational Model: | Family-Based |
Time Perspective: | Prospective |
Official Title: | Whole Blood Specimen Collection From Pregnant Subjects |
Actual Study Start Date : | March 2015 |
Estimated Primary Completion Date : | March 2021 |
Estimated Study Completion Date : | May 2021 |

- Whole blood collection [ Time Frame: One or more monthly clinic visits (≥25 days apart) over 13 weeks ]
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02430584
United States, Tennessee | |
Regional Obstetrical Consultants | |
Chattanooga, Tennessee, United States, 37403 |
Responsible Party: | Progenity, Inc. |
ClinicalTrials.gov Identifier: | NCT02430584 |
Other Study ID Numbers: |
PRO-101-SAMPLES |
First Posted: | April 30, 2015 Key Record Dates |
Last Update Posted: | September 17, 2020 |
Last Verified: | September 2020 |
DiGeorge Syndrome Down Syndrome Trisomy 13 Syndrome Turner Syndrome Klinefelter Syndrome Trisomy 18 Syndrome Syndrome Disease Pathologic Processes Intellectual Disability Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Abnormalities, Multiple Congenital Abnormalities |
Chromosome Disorders Genetic Diseases, Inborn Gonadal Dysgenesis Disorders of Sex Development Urogenital Abnormalities Sex Chromosome Disorders of Sex Development Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases Sex Chromosome Disorders Gonadal Disorders Endocrine System Diseases Hypogonadism 22q11 Deletion Syndrome |