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

NCT00006445 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38000

Last updated 2007-02-22

No results posted yet for this study

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.

Conditions

  • Down Syndrome
  • Chromosome Abnormalities

Interventions

PROCEDURE

Ultrasound

PROCEDURE

Serum screen

Sponsors & Collaborators

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

    lead NIH

Principal Investigators

  • Mary E. D'Alton, M. D. · Columbia-Presbyterian Hospital Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00006445 on ClinicalTrials.gov