Specimen Collection from Pregnant Women At Increased Risk for Fetal Aneuploidy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Down Syndrome, Fetal Aneuploidy. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 12 centers
- University of Alabama Birmingham — Birmingham
- Cedars-Sinai Medical Center — Los Angeles
- Sharp-Rees Stealy Medical Group — San Diego
- UCSD — San Diego
- Women's Health Care Research — San Diego
- Specialty Obstetrics of San Diego — San Diego
- Reproductive Genetics Institute — Chicago
- University of Iowa Health Care — Iowa City
- … and 4 more centers
Canada · 2 centers
- IWK Health Centre — Halifax
- North York General Hospital — Toronto
Identifiers
NCT: NCT01429389 · SQNM-T21-107