Down Syndrome - Comparison of Screening Methods in the 1st and 2nd Trimesters
First and 2nd Trimester Evaluation of the Risk of Aneuploidy
2 other identifiers
interventional
38,000
1 country
10
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 4, 2000
CompletedFirst Posted
Study publicly available on registry
November 6, 2000
CompletedFebruary 22, 2007
March 1, 2003
November 4, 2000
February 21, 2007
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Multiple gestation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
University of Colorado Health Sciences Center
Denver, Colorado, 80262, United States
New England Medical Center
Boston, Massachusetts, 02111, United States
William Beaumont Hospital Research Institute
Royal Oak, Michigan, 48073-6769, United States
New York University School of Medicine
New York, New York, 10016, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
Women and Infants Hospital
Providence, Rhode Island, 02905, United States
University of Texas Medical Branch
Galveston, Texas, 77555-0587, United States
University of Utah
Salt Lake City, Utah, 84132, United States
Swedish Medical Center
Seattle, Washington, 98104-1377, United States
Related Publications (3)
Wald NJ, Kennard A, Hackshaw A, McGuire A. Antenatal screening for Down's syndrome. J Med Screen. 1997;4(4):181-246. doi: 10.1177/096914139700400402.
PMID: 9494915BACKGROUNDWald NJ, Hackshaw AK. Combining ultrasound and biochemistry in first-trimester screening for Down's syndrome. Prenat Diagn. 1997 Sep;17(9):821-9.
PMID: 9316126BACKGROUNDMalone FD, D'Alton, MD. Fetal nuchal translucency. Contemporary Obstetrics and Gyncology 1998; 43: 117-31.
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mary E. D'Alton, M. D.
Columbia-Presbyterian Hospital Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
Study Record Dates
First Submitted
November 4, 2000
First Posted
November 6, 2000
Last Updated
February 22, 2007
Record last verified: 2003-03