Specimen Collection From Pregnant Women at Increased Risk for Fetal Aneuploidy

NCT01429389 · tracked via the Priya Life Science USA tracker

Sponsor

Sequenom, Inc.

Phase

Observational

Started

2011-05

Last updated

2026-09-09

Condition(s) studied

Down SyndromeFetal Aneuploidy

Study summary

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

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Collect samples and data for assay validation. — 9-24 weeks of gestatational age
Sensitivity and Specificity

Trial sites (14)

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

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Other trials for the same condition

Effects of Hypoglossal Nerve Stimulation on Cognition and Language in Down Syndrome and Obstructive Sleep Apnea Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01429389 on ClinicalTrials.gov ↗ ← All trials in the USA