Down Syndrome Clinical Trial
Official title:
First and 2nd Trimester Evaluation of the Risk of Aneuploidy
Too much or too little genetic information (chromosome material) can cause abnormal development of the fetus or death. Each year approximately 2.5 million pregnant women are screened for Down Syndrome using invasive screening methods (amniocentesis or chorionic villus sampling). This 11 center study of 38,000 women will compare the accuracy of the several non-invasive tests in the first and second trimesters of pregnancy versus amniocentesis or diagnosis at birth to diagnose aneuploidy or Down Syndrome.
Status | Active, not recruiting |
Enrollment | 38000 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 16 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Women 16 to 45 years old - Enrolled by participating obstetrical center before 10-14 weeks gestation - Gestational age 10 weeks three days to 13 weeks six days, with a minimum sonographic crown rump length of 38 mm, maximum 84mm - Informed consent of patient - English fluent or accompanied by appropriate interpreter - Healthy (although co-existing diseases allowed) Exclusion Criteria: - Multiple gestation |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | New England Medical Center | Boston | Massachusetts |
United States | Montefiore Medical Center | Bronx | New York |
United States | University of Colorado Health Sciences Center | Denver | Colorado |
United States | University of Texas Medical Branch | Galveston | Texas |
United States | Mount Sinai Medical Center | New York | New York |
United States | New York University School of Medicine | New York | New York |
United States | Women and Infants Hospital | Providence | Rhode Island |
United States | William Beaumont Hospital Research Institute | Royal Oak | Michigan |
United States | University of Utah | Salt Lake City | Utah |
United States | Swedish Medical Center | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
Malone FD, D'Alton, MD. Fetal nuchal translucency. Contemporary Obstetrics and Gyncology 1998; 43: 117-31.
Wald NJ, Hackshaw AK. Combining ultrasound and biochemistry in first-trimester screening for Down's syndrome. Prenat Diagn. 1997 Sep;17(9):821-9. — View Citation
Wald NJ, Kennard A, Hackshaw A, McGuire A. Antenatal screening for Down's syndrome. J Med Screen. 1997;4(4):181-246. Review. Erratum in: J Med Screen 1998;5(2):110. J Med Screen 1998;5(3):166. — View Citation
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