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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02430584|
Recruitment Status : Unknown
Verified May 2016 by Progenity, Inc..
Recruitment status was: Recruiting
First Posted : April 30, 2015
Last Update Posted : May 5, 2016
|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|
|Official Title:||Whole Blood Specimen Collection From Pregnant Subjects|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||March 2017|
|Estimated Study Completion Date :||June 2017|
- Whole blood collection [ Time Frame: One or more monthly clinic visits (≥25 days apart) over 13 weeks ]
Biospecimen Retention: Samples With DNA
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
|Contact: Paul A Bien, MSfirstname.lastname@example.org|
|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|