Specimen Collection from Pregnant Women At Increased Risk for Fetal Aneuploidy
- Conditions
- Down SyndromeFetal Aneuploidy
- Registration Number
- NCT01429389
- Lead Sponsor
- Sequenom, Inc.
- Brief Summary
The specimen collection is designed for the purpose of the development of a noninvasive prenatal test for T21.
- Detailed Description
To collect specimens for the purpose of developing a prenatal aneuploidy test. The test will analyze circulating cell free fetal (ccff) nucleic acid from blood samples from pregnant women who have an increased risk indicator/s for fetal chromosomal aneuploidy and are undergoing invasive prenatal diagnosis by chorionic villus sampling (CVS) and/or genetic amniocentesis. The results of the ccff aneuploidy test will be compared to the chromosomal analysis obtained via CVS or genetic amniocentesis.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 2000
- pregnant between 10 and 22 weeks gestation
- 18 years of age or older
- provides signed and dated informed consent
- subject is at increased risk for fetal aneuploidy
- subject is willing to undergo a CVS and/or amniocentesis procedure for the purpose of genetic analysis
- subject agrees to provide the genetic results of the invasive procedure
- Fetal demise at time of specimen sampling
- Previous sample donation under this protocol
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (14)
University of Alabama Birmingham
🇺🇸Birmingham, Alabama, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Sharp-Rees Stealy Medical Group
🇺🇸San Diego, California, United States
UCSD
🇺🇸San Diego, California, United States
Women's Health Care Research
🇺🇸San Diego, California, United States
Specialty Obstetrics of San Diego
🇺🇸San Diego, California, United States
Reproductive Genetics Institute
🇺🇸Chicago, Illinois, United States
University of Iowa Health Care
🇺🇸Iowa City, Iowa, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Spectrum Health
🇺🇸Grand Rapids, Michigan, United States
The Cooper Health System
🇺🇸Camden, New Jersey, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
IWK Health Centre
🇨🇦Halifax, Nova Scotia, Canada
North York General Hospital
🇨🇦Toronto, Ontario, Canada