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Down Syndrome - Comparison of Screening Methods in the 1st and 2nd Trimesters Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Down Syndrome - Comparison of Screening Methods in the 1st and 2nd Trimesters conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Down Syndrome - Comparison of Screening Methods in the 1st and 2nd Trimesters Clinical research trials and Down Syndrome - Comparison of Screening Methods in the 1st and 2nd Trimesters medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Down Syndrome - Comparison of Screening Methods in the 1st and 2nd Trimesters. Down Syndrome - Comparison of Screening Methods in the 1st and 2nd Trimesters Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Down Syndrome - Comparison of Screening Methods in the 1st and 2nd Trimesters clinical trial. Participants oftentimes recieve the finest healthcare available for their Down Syndrome - Comparison of Screening Methods in the 1st and 2nd Trimesters condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "D" Clinical Trials Conditions > Down Syndrome - Comparison of Screening Methods in the 1st and 2nd Trimesters  Down Syndrome - Comparison of Screening Methods in the 1st and 2nd Trimesters
Down Syndrome - Comparison of Screening Methods in the 1st and 2nd Trimesters
For Condition: Down Syndrome,Chromosome Abnormalities
Status: No longer recruiting
Sponsor(s): National Institute of Child Health and Human Development (NICHD) ,
Synopsis: 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.
Details: The FASTER (First and Second Trimester Evaluation of Risk) Trial is a multicenter prospective study comparing the accuracy of first and second trimester non-invasive screening methods for Down syndrome and other aneuploidies to diagnosis at delivery or miscarriage/fetal loss). All women will receive the two non-invasive test batteries in both the first and second trimesters. The accuracy of the results of different combinations of non-invasive tests will be compared with diagnosis at delivery or at miscarriage or later fetal loss. First trimester screening will involve ultrasound measurement of fetal nuchal translucency (NT) thickness at 10-14 weeks gestation, together with maternal age, and serum levels of pregnancy associated plasma protein-A (PPAP-A) and free-beta human chorionic gonadotropin (FbhCG). Second trimester screening will be based on the current standard of care serum "triple screen", which consists of alpha fetoprotein (AFP), unconjugated estriol (uE3), and hCG, performed at 15-18 weeks gestation, together with maternal age and the new serum marker inhibin-A. If patients screen positive (risk >/= 1 in 380), the patients are notified and offered invasive testing at 15 weeks (a serum "quad" test, an additional tube of blood for analysis of the presence of fetal nucleated erythrocytes in maternal blood [NIFTY: National Institute of Child Health and Human Development Fetal Cell Study]), and amniocentesis on those who accept). True positive cases receive counseling. True negative cases, those who decline invasive testing, and those who screen negative after the serum "quad" test, receive routine care with final pediatric outcome. Patients with an a priori risk for Down Syndrome may elect to have invasive fetal testing at 15 weeks after quad testing. For all fetuses with a NT measurement greater than 3 mm, and where karyotype is found to be normal after amniocentesis, will be followed with a repeat ultrasound examination at 18 to 20 weeks gestation, to evaluate fetal anatomy, particularly fetal cardiac structure. Final pediatric examination information will be obtained following delivery. If pregnancy results in miscarriage or later fetal loss, attempts will be made to karyotype any fetal tissue. This is especially important for those pregnancies that abort spontaneously between the time of the first and second trimester methods of screening. Pregnancy outcome data will be obtained in all cases.
Eligibility:
Study Type: Interventional, Diagnostic, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Minimum Age/Maximum Age: 16 Years/45 Years
Genders: Female
Protocol Entry Criteria: 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
Total Enrollment: 38000
Location and Contact Information:
Overall Study Official:
MaryD'Alton, Principal Investigator, Columbia-Presbyterian Hospital Medical Center
Swedish Medical Center
Seattle, Washington, 98104-1377
United States
Montefiore Medical Center
Bronx, New York, 10461
United States
Mount Sinai Medical Center
New York City, New York, 10029
United States
New York University School of Medicine
New York City, New York, 10016
United States
William Beaumont Hospital Research Institute
Royal Oak, Michigan, 48073-6769
United States
University of Utah
Salt Lake City, Utah, 84132
United States
University of Colorado Health Sciences Center
Denver, Colorado, 80262
United States
University of Texas Medical Branch
Galveston, Texas, 77555-0587
United States
New England Medical Center
Boston, Massachusetts, 02111
United States
Women and Infants Hospital
Providence, Rhode Island, 02905
United States
Additional Information:
Study ID Numbers: NICHD-0511; 1 RO1 HD37523
Study Start Date:
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006445
Other Chromosome Abnormalities Studies:
1. Study of Phenotype and Genotype Correlations in Patients With Contiguous Gene Deletion Syndromes
2. Natural History Study of Smith-Magenis Syndrome
3. Down Syndrome - Comparison of Screening Methods in the 1st and 2nd Trimesters
4. Immunologic Evaluation in Patients With DiGeorge Syndrome or Velocardiofacial Syndrome
Related Studies:
Other Chromosome Abnormalities Clinical Trials
Other Washington Clinical Trials
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Down Syndrome - Comparison of Screening Methods in the 1st and 2nd Trimesters
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