Down Syndrome - Comparison of Screening Methods in the 1st and 2nd Trimesters

Status unconfirmed · Not applicable

Conditions studied: Down Syndrome, Chromosome Abnormalities

In brief

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.

Key facts

Study ID

NCT00006445

Run by

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

People needed

38000

Last updated by the study team

2007-02-22

Who can join

Age: 16 and older, up to 45. Sex: female. Healthy volunteers: accepted.

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

Where it is running

• University of Colorado Health Sciences Center — Denver, Colorado, United States
• New England Medical Center — Boston, Massachusetts, United States
• William Beaumont Hospital Research Institute — Royal Oak, Michigan, United States
• New York University School of Medicine — New York, New York, United States
• Mount Sinai Medical Center — New York, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Women and Infants Hospital — Providence, Rhode Island, United States
• University of Texas Medical Branch — Galveston, Texas, United States
• University of Utah — Salt Lake City, Utah, United States
• Swedish Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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