A Noninvasive Test for Fetal RHD Genotype (NAFTnet RHD)

May 9, 2012 updated by: Sequenom, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

520

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3N1
        • University of British Columbia
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X5
        • Mt. Sinai School of Medicine
    • Quebec
      • Montreal, Quebec, Canada, H3A 1A1
        • McGill University
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Obstetrix Medical Group of Phoenix
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State University
    • New York
      • New York, New York, United States, 10029
        • Mt. Sinai School of Medicine
      • New York City, New York, United States, 10032
        • Columbia University
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina
    • Ohio
      • Cincinnati, Ohio, United States, 43210
        • Good Samaritan Hospital
      • Columbus, Ohio, United States, 45211
        • Ohio State University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
    • Washington
      • Kirkland, Washington, United States, 98034
        • Evergreen Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Pregnant women who are known to be serologically RhD negative.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To test as to whether advancing gestational age is associated with accuracy of fetal typing for RhD.
Time Frame: First, second, and third trimester
First, second, and third trimester

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sequenom, Inc.

Collaborators

NAFTNet

Investigators

  • Principal Investigator: Kenneth Moise, MD, Baylor College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (ACTUAL)

November 1, 2011

Study Completion (ACTUAL)

April 1, 2012

Study Registration Dates

First Submitted

March 26, 2009

First Submitted That Met QC Criteria

March 27, 2009

First Posted (ESTIMATE)

March 30, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

May 10, 2012

Last Update Submitted That Met QC Criteria

May 9, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SQNM-RHD-301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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