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

Sponsor:

Information provided by (Responsible Party):

Progenity, Inc.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment
Down Syndrome Edwards Syndrome Patau Syndrome Klinefelter Syndrome Turner Syndrome DiGeorge Syndrome Perinatal Infections	Other: Observational - no intervention

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Trisomy 13 Turner syndrome Trisomy 18

Genetic and Rare Diseases Information Center resources: 22q11.2 Deletion Syndrome Shprintzen-Goldberg Craniosynostosis Syndrome Turner Syndrome Gonadal Dysgenesis Trisomy 18 Trisomy 13 Chromosomal Triplication Lymphatic Malformations Hypoparathyroidism

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

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

Biospecimen Retention: Samples With DNA

Study will collect up to 50 mL of whole blood at one or more monthly clinic visits (≥25 days apart) from pregnant women carrying a single fetus of 10 to 26 weeks of gestational age

Eligibility Criteria

Information from the National Library of Medicine

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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

Study Population

GENDER: Female ETHNICITY: All ethnicities RACE: All races AGE: Subjects 18 years of age or older

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

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

Locations

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United States, Tennessee
Regional Obstetrical Consultants
Chattanooga, Tennessee, United States, 37403

Sponsors and Collaborators

Progenity, Inc.

More Information

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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

Additional relevant MeSH terms:

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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

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