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NCT Number: NCT00871195

A Noninvasive Test for Fetal RHD Genotype

The objective of this study is to evaluate the performance of Sequenom's noninvasive test for fetal RHD genotype. The test uses MALDI-TOF mass spectrometry to detect DNA. The study is specifically designed to determine whether RHD typing using free fetal DNA in maternal circulation can accurately predict the neonatal RhD phenotype at birth.

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Key information

Conditions

Rhesus D Genotype

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of British Columbia, Vancouver, British Columbia, Canada

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About this study

In the United States and Canada, routine obstetrical care includes a blood test to determine the blood type of the mother (ABO and RhD). An antibody screen for anti-red cell antibodies in the mother's serum is also performed.

Postpartum prophylactic treatment of RhD negative women with anti-D immunoglobulin to prevent "RhD Disease", or hemolytic disease of the fetus/newborn, was initiated in the 1960's. In the mid 1980's, the routine administration of antenatal anti-D immunoglobulin became the standard of care as well. Although these treatments have dramatically reduced the incidence of RhD Disease, approximately 40% of all RhD negative pregnancies continue to receive unnecessary injections of antenatal anti-D immunoglobulin.

Genotyping platforms such as MALDI-TOF mass spectrometry allow for precise and sensitive detection of fetal-specific (paternally derived) alleles in maternal plasma. In this study, Sequenom's MassARRAY technology will be used to assess a noninvasive test for fetal RHD genotyping in a clinical setting.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female at least 18 years of age
  • RhD negative by serology
  • Pregnant at no more than 11-13 weeks gestation confirmed by ultrasound
  • Willing to provide signed and dated informed consent
  • Able and willing to comply with the protocol

Exclusion criteria

  • RhD negative women known to be alloimmunized to the RhD antigen

Treatment and study plan

Primary outcomes

  1. To test as to whether advancing gestational age is associated with accuracy of fetal typing for RhD.

    Time frame: First, second, and third trimester

Sponsors and collaborators

Lead sponsor

Sequenom, Inc.

Industry

Collaborators

  • NAFTNet

Registry information

Official study title

Evaluation Of The Performance Of A Noninvasive Test For Fetal RHD Genotype On The Sequenom MassARRAY System

Acronym: NAFTnet RHD

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Mar 30, 2009
Registry last updated
May 10, 2012

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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