Evaluation of a Noninvasive Fetal RHD Genotyping Test

Overview

This study will collect whole blood samples from pregnant subjects who are RhD negative by serology to develop an assay for RHD determination of the fetus.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 2010

Clinical Trial Outcome Measures

Primary Measures

  • Fetal RHD determination from maternal whole blood
    • Time Frame: Between 10 and 28 weeks gestation

Participating in This Clinical Trial

Inclusion Criteria

  • Subject is 18-64 years of age
  • Subject is female
  • Subject is pregnant
  • Subject is RhD negative
  • Subject is between 10 and 28 weeks gestation
  • Subject provides informed consent
  • Subject agrees to provide neonatal RHD and sex outcome

Exclusion Criteria

  • None

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 64 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sequenom, Inc.
  • Collaborator
    • Sequenom Center for Molecular Medicine
  • Provider of Information About this Clinical Study
    • Sponsor

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