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.

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.

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

sites

Practice Research Organization, Inc.

Dallas, Texas 75230

Principal Investigator: Kathryn Waldrep, MD

Phone: 972-566-4660

from

Dallas, TX