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OpenTrials
Completed

NCT Number: NCT01054716

Evaluation of a Noninvasive Fetal RHD Genotyping Test

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.

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Key information

Conditions

Rhesus D Genotype

Age range

18 year–64 year

Sex eligibility

Female

Study type

Observational

Primary location

Scripps Hospitals (5 San Diego locations), San Diego, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Fetal RHD determination from maternal whole blood

    Time frame: Between 10 and 28 weeks gestation

Sponsors and collaborators

Lead sponsor

Sequenom, Inc.

Industry

Collaborators

  • Sequenom Center for Molecular Medicine

Registry information

Acronym: IRIS

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 22, 2010
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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