Non-Invasive Screening for Fetal Aneuploidy
- Conditions
- Edwards SyndromeDown Syndrome
- Interventions
- Other: Maternal blood screening test for fetal aneuploidy
- Registration Number
- NCT00847990
- Lead Sponsor
- Sequenom, Inc.
- Brief Summary
The purpose of this study is to determine if a laboratory test developed by the Sequenom Center for Molecular Medicine (SCMM) that uses a new marker found in the mother's blood can better identify pregnancies that have a child with a chromosome abnormality such as Down syndrome (Trisomy 21), Edwards syndrome (Trisomy 18), or other chromosome abnormality.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 5000
- Subject is willing to provide written informed consent
- Pregnant female with singleton gestation 18 years of age or older
- Subject agrees to provide a 20 to 30 mL venous blood sample
- Subject is one of the following: A) currently scheduled to undergo an amniocentesis and/or CVS procedure, OR B) currently in the first trimester of pregnancy and planning to undergo an amniocentesis in the second trimester
- Subject will receive results of a genetic analysis that includes evaluation of the fetus for aneuploidy
- Subject lacks the capacity to provide informed consent
- Twins, triplets or other multiple gestation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Pregnant women Maternal blood screening test for fetal aneuploidy Pregnant women who are scheduled to undergo an amniocentesis or CVS procedure and will receive the fetal FISH and/or karyotype results from the procedure.
- Primary Outcome Measures
Name Time Method Validate the prenatal aneuploidy LDT with blood samples from pregnant women who are undergoing invasive prenatal diagnosis During the 1st and 2nd trimester of pregnancy
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (25)
Desert Good Samaritan Hospital
🇺🇸Mesa, Arizona, United States
Long Beach Memorial Medical Center - Magella Medical Group
🇺🇸Long Beach, California, United States
Obstetric Perinatal Clinic Tucson (WOMB)
🇺🇸Tucson, Arizona, United States
Regional Obstetrical Consultants, Knoxville Tennessee
🇺🇸Knoxville, Tennessee, United States
Obstetrix Medical Group - Colorado at Presbyterian/St. Luke's Center
🇺🇸Denver, Colorado, United States
Obstetrix Medical Group of California - Hamilton
🇺🇸San Jose, California, United States
Obstetrix Medical Group Colorado - Antepartum Testing Unit at Rose Medical Center
🇺🇸Denver, Colorado, United States
Obstetrix Medical Group Colorado at Skyridge Medical Center
🇺🇸Lonetree, Colorado, United States
Obstetrix Medical Group Colorada - Perinatal Resource Center at Swedish Medical Center
🇺🇸Englewood, Colorado, United States
Obstetrix Medical Group - Colorado at Littleton Adventist Hospital Perinatal Care Center
🇺🇸Littleton, Colorado, United States
Maternal Fetal Specialist of John's Creek
🇺🇸Duluth, Georgia, United States
Obstetrix Medical Group of Kansas City, Missouri, Saint Luke's Perinatal Center
🇺🇸Kansas City, Missouri, United States
Maternal Fetal Specialists - Gwinnett
🇺🇸Lawrenceville, Georgia, United States
Regional Obstetrical Consultants, Chattanooga Tennessee
🇺🇸Chattanooga, Tennessee, United States
Obstetrix Medical Group of Washington, Eastside Maternal Fetal Medicine
🇺🇸Bellevue, Washington, United States
Obstetrix Medical Group of Washington, MFM Clinic at Evergreen Medical Center
🇺🇸Kirkland, Washington, United States
Fetal Diagnostic Center
🇺🇸Laguna Hills, California, United States
Maternal Fetal Specialists - Northside Atlanta Geogia
🇺🇸Atlanta, Georgia, United States
Center for Maternal Fetal Medicine - 7 Hills Office
🇺🇸Las Vegas, Nevada, United States
Center for Maternal Fetal Medicine - Pinto Office
🇺🇸Las Vegas, Nevada, United States
Center for Maternal Fetal Medicine - Post Road Office
🇺🇸Las Vegas, Nevada, United States
Texas Prenatal Group of San Antonio
🇺🇸San Antonio, Texas, United States
Obstetrix Medical Group of Washington, Inc
🇺🇸Seattle, Washington, United States
Banner Good Samaritan Hospital
🇺🇸Phoenix, Arizona, United States
Phoenix Perinatal Associates, Phoenix Arizona Clinic
🇺🇸Phoenix, Arizona, United States