Specimen Collection from Pregnant Women At Increased Risk for Fetal Aneuploidy

Recruiting now

Conditions studied: Down Syndrome, Fetal Aneuploidy

In brief

The specimen collection is designed for the purpose of the development of a noninvasive prenatal test for T21.

Key facts

Study ID

NCT01429389

Run by

Sequenom, Inc.

People needed

2000

Starts

2011-05-01

Expected to finish

2026-03-01

Last updated by the study team

2024-10-16

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Fetal demise at time of specimen sampling
• Previous sample donation under this protocol

Where it is running

• University of Alabama Birmingham — Birmingham, Alabama, United States (enrolling)
• Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
• Sharp-Rees Stealy Medical Group — San Diego, California, United States (enrolling)
• UCSD — San Diego, California, United States (enrolling)
• Women's Health Care Research — San Diego, California, United States (enrolling)
• Specialty Obstetrics of San Diego — San Diego, California, United States (enrolling)
• Reproductive Genetics Institute — Chicago, Illinois, United States (enrolling)
• University of Iowa Health Care — Iowa City, Iowa, United States (enrolling)
• Henry Ford Hospital — Detroit, Michigan, United States (enrolling)
• Spectrum Health — Grand Rapids, Michigan, United States (enrolling)
• The Cooper Health System — Camden, New Jersey, United States (enrolling)
• Medical University of South Carolina — Charleston, South Carolina, United States (enrolling)
• IWK Health Centre — Halifax, Nova Scotia, Canada (enrolling)
• North York General Hospital — Toronto, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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