Collection of Whole Blood Specimens in Pregnant Women
Status: | Recruiting |
---|---|
Conditions: | Women's Studies |
Therapuetic Areas: | Reproductive |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 7/20/2018 |
Start Date: | February 13, 2017 |
End Date: | December 31, 2019 |
Contact: | Linda Leety |
Email: | lleety@illumina.com |
Phone: | (239) 565-3712 |
Prospective Collection of Whole Blood Specimens in Pregnant Women
To prospectively collect whole blood specimens and clinical data from pregnant women
scheduled for an invasive prenatal diagnostic procedure ("invasive procedure"). Specimens
will be used for future testing with an investigational NIPT.
scheduled for an invasive prenatal diagnostic procedure ("invasive procedure"). Specimens
will be used for future testing with an investigational NIPT.
This is a prospective multicenter study in which whole blood specimens will be collected from
pregnant women scheduled for an invasive procedure.
After the standard-of-care invasive procedure is performed in accordance with the site's
clinical procedures, invasive prenatal diagnostic procedure results will also be collected.
pregnant women scheduled for an invasive procedure.
After the standard-of-care invasive procedure is performed in accordance with the site's
clinical procedures, invasive prenatal diagnostic procedure results will also be collected.
Inclusion Criteria:
- Be 18 years of age or older at enrollment,
- Has a viable pregnancy (with documented fetal heartbeat) of at least 10 weeks, 0 days
gestation at the time of maternal specimen collection,
- Be scheduled for an invasive prenatal diagnostic procedure (either chorionic villus
sampling [CVS], amniocentesis, or percutaneous umbilical cord blood sampling
[cordocentesis]) for cytogenetic analysis of the fetus
Exclusion Criteria:
- Has a known maternal chromosomal anomaly,
- Had an invasive prenatal diagnostic procedure in the current pregnancy before maternal
specimen collection
- Has a history of transplant or malignancy, or
- Had a transfusion of blood or blood components up to 8 weeks before maternal whole
blood specimen collection
- Already participated in this study (enrolled previously).
We found this trial at
6
sites
Los Angeles, California 90048
Principal Investigator: Lawrence D Platt, MD
Phone: 323-857-1952
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Dallas, Texas 75230
Principal Investigator: Kathryn Waldrep, MD
Phone: 972-566-4660
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Las Vegas, Nevada
Principal Investigator: Joseph Adashek, MD
Phone: 702-341-6610
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Norfolk, Virginia 23507
Principal Investigator: Steven L Warsof, MD
Phone: 757-446-0579
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Riverside, California 92506
Principal Investigator: Herb Brar, MD
Phone: 951-683-4675
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