Collecting samples from pregnant women at risk for fetal chromosomal abnormalities
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
Sequenom, Inc. · NCT01429389
This study is testing a new blood test for pregnant women at risk of having a baby with Down syndrome to see if it can provide accurate results compared to traditional testing methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Sequenom, Inc. (industry) |
| Locations | 14 sites (Birmingham, Alabama and 13 other locations) |
| Trial ID | NCT01429389 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect blood samples from pregnant women who are at increased risk for fetal aneuploidy, specifically Down syndrome. The collected specimens will be used to develop a noninvasive prenatal test that analyzes circulating cell-free fetal nucleic acid. Participants will also undergo invasive prenatal diagnostic procedures, such as chorionic villus sampling or amniocentesis, to compare the results of the new test with traditional chromosomal analysis. The goal is to enhance prenatal screening methods for fetal aneuploidy.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 18 or older, between 10 and 22 weeks of gestation, who are at increased risk for fetal aneuploidy and willing to undergo invasive testing.
Not a fit: Patients who have experienced fetal demise at the time of specimen sampling or those who have previously donated samples under this protocol may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a safer, noninvasive prenatal testing option for detecting fetal aneuploidies.
How similar studies have performed: Other studies have shown promise in developing noninvasive prenatal tests, indicating a potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Birmingham, Alabama and 13 other locations
- University of Alabama Birmingham — Birmingham, Alabama, United States (RECRUITING)
- Cedars-Sinai Medical Center — Los Angeles, California, United States (RECRUITING)
- Sharp-Rees Stealy Medical Group — San Diego, California, United States (RECRUITING)
- UCSD — San Diego, California, United States (RECRUITING)
- Women's Health Care Research — San Diego, California, United States (RECRUITING)
- Specialty Obstetrics of San Diego — San Diego, California, United States (RECRUITING)
- Reproductive Genetics Institute — Chicago, Illinois, United States (RECRUITING)
- University of Iowa Health Care — Iowa City, Iowa, United States (RECRUITING)
- Henry Ford Hospital — Detroit, Michigan, United States (RECRUITING)
- Spectrum Health — Grand Rapids, Michigan, United States (RECRUITING)
- The Cooper Health System — Camden, New Jersey, United States (RECRUITING)
- Medical University of South Carolina — Charleston, South Carolina, United States (RECRUITING)
- IWK Health Centre — Halifax, Nova Scotia, Canada (RECRUITING)
- North York General Hospital — Toronto, Ontario, Canada (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Down Syndrome, Fetal Aneuploidy, Down syndrome, fetal aneuploidy, trisomy, noninvasive screening test