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Specimen Collection From Pregnant Women at Increased Risk for Fetal Aneuploidy

RecruitingObservational study

Collection of Whole Blood Specimens From Pregnant Women at Increased Risk of Fetal Chromosomal Abnormality for Use in Development of a Noninvasive Prenatal Test in the Detection of the Relative Quantity of Chromosomal Material in Circulating Cell-Free DNA Extracted From Maternal Plasma

Who can join

Ages 18 and older · Women

Full eligibility criteria
Inclusion Criteria:

* 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

Exclusion Criteria:

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

About the study

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

Sponsor: Sequenom, Inc. · Participants: 2,000 · Started: 2011-05

Contact the study team

Official record on ClinicalTrials.gov — NCT01429389

Locations in the U.S.

AlabamaUniversity of Alabama Birmingham, Birmingham
CaliforniaCedars-Sinai Medical Center, Los Angeles
Sharp-Rees Stealy Medical Group, San Diego
Specialty Obstetrics of San Diego, San Diego
UCSD, San Diego
Women's Health Care Research, San Diego
IllinoisReproductive Genetics Institute, Chicago
IowaUniversity of Iowa Health Care, Iowa City
MichiganHenry Ford Hospital, Detroit
Spectrum Health, Grand Rapids
New JerseyThe Cooper Health System, Camden
South CarolinaMedical University of South Carolina, Charleston

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.