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OpenTrials
Completed

NCT Number: NCT00847990

Non-Invasive Screening for Fetal Aneuploidy

The purpose of this study is to determine if a laboratory test developed by the Sequenom Center for Molecular Medicine (SCMM) that uses a new marker found in the mother's blood can better identify pregnancies that have a child with a chromosome abnormality such as Down syndrome (Trisomy 21), Edwards syndrome (Trisomy 18), or other chromosome abnormality.

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Key information

Conditions

Down Syndrome Abnormalities, Multiple Aneuploidy Cardiovascular Abnormalities Cardiovascular Diseases Chromosome Aberrations Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Edwards Syndrome Genetic Diseases, Inborn Heart Defects, Congenital Heart Diseases Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Trisomy 18 Syndrome

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Desert Good Samaritan Hospital, Mesa, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject is willing to provide written informed consent
  • Pregnant female with singleton gestation 18 years of age or older
  • Subject agrees to provide a 20 to 30 mL venous blood sample
  • Subject is one of the following: A) currently scheduled to undergo an amniocentesis and/or CVS procedure, OR B) currently in the first trimester of pregnancy and planning to undergo an amniocentesis in the second trimester
  • Subject will receive results of a genetic analysis that includes evaluation of the fetus for aneuploidy

Exclusion criteria

  • Subject lacks the capacity to provide informed consent
  • Twins, triplets or other multiple gestation

Treatment and study plan

Maternal blood screening test for fetal aneuploidy

Other

One blood draw of 20 to 30 mL

Primary outcomes

  1. Validate the prenatal aneuploidy LDT with blood samples from pregnant women who are undergoing invasive prenatal diagnosis

    Time frame: During the 1st and 2nd trimester of pregnancy

Sponsors and collaborators

Lead sponsor

Sequenom, Inc.

Industry

Collaborators

  • Obstetrix

Registry information

Official study title

Non-Invasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Feb 20, 2009
Registry last updated
Sep 5, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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