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Whole Blood Specimen Collection From Pregnant Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02430584
Recruitment Status : Recruiting
First Posted : April 30, 2015
Last Update Posted : August 21, 2019
Information provided by (Responsible Party):
Progenity, Inc.

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:

  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.

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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 2020
Estimated Study Completion Date : May 2020

Primary Outcome Measures :
  1. 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

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

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

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 identifier (NCT number): NCT02430584

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Contact: Peter Stiegler, PhD 760-494-1743

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United States, Tennessee
Regional Obstetrical Consultants Recruiting
Chattanooga, Tennessee, United States, 37403
Contact: C. David Adair, MD    423-664-4460      
Contact: Lorrie Mason, NNP    423-664-4460      
Sponsors and Collaborators
Progenity, Inc.

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Responsible Party: Progenity, Inc. Identifier: NCT02430584     History of Changes
Other Study ID Numbers: PRO-101-SAMPLES
First Posted: April 30, 2015    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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DiGeorge Syndrome
Down Syndrome
Trisomy 13 Syndrome
Turner Syndrome
Klinefelter Syndrome
Trisomy 18 Syndrome
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
22q11 Deletion Syndrome