Development of a Fetal Sex Assay From Maternal Whole Blood
Whole blood from pregnant women will be collected to develop a noninvasive fetal sex test.
Fetal Sex Determination
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Development of a Noninvasive Fetal Sex Determination Test Between 6 and 16 Weeks of Gestation|
Plasma and PBMCs
|Study Start Date:||June 2008|
|Study Completion Date:||July 2010|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
Women who are pregnant and between 6 and 16 weeks of gestation and who are 18 to 64 years of age.
This is an observational study whereby samples will be tested to determine the presence or absence of fetal Y chromosome genes to test for the fetal sex of the baby. The blood draw will occur between 6 to 16 weeks of gestation. The fetal gender will be requested at or soon after delivery if fetal sex was not previously obtained by CVS or amniocentesis genetic analysis.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00970047
|United States, California|
|San Diego, California, United States, 92121|
|NCOG Medical Group|
|San Diego, California, United States, 92037|
|Scripps Clinic Medial Group|
|San Diego, California, United States, 92128|
|Study Director:||Allan Bombard, MD, MBA||Sequenom, Inc.|