A Noninvasive Test for Fetal RHD Genotype (NAFTnet RHD)

This study has been completed.
Sponsor:
Collaborator:
NAFTNet
Information provided by (Responsible Party):
Sequenom, Inc.
ClinicalTrials.gov Identifier:
NCT00871195
First received: March 26, 2009
Last updated: May 9, 2012
Last verified: May 2012
  Purpose

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.


Condition
Rhesus D Genotype

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation Of The Performance Of A Noninvasive Test For Fetal RHD Genotype On The Sequenom MassARRAY System

Further study details as provided by Sequenom, Inc.:

Primary Outcome Measures:
  • To test as to whether advancing gestational age is associated with accuracy of fetal typing for RhD. [ Time Frame: First, second, and third trimester ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

Plasma and buffy coat.


Enrollment: 520
Study Start Date: April 2009
Study Completion Date: April 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Pregnant women who are known to be serologically RhD negative.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00871195

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

No publications provided

Responsible Party: Sequenom, Inc.
ClinicalTrials.gov Identifier: NCT00871195     History of Changes
Other Study ID Numbers: SQNM-RHD-301
Study First Received: March 26, 2009
Last Updated: May 9, 2012
Health Authority: United States: Institutional Review Board
Canada: Health Canada

Keywords provided by Sequenom, Inc.:
Rhesus D
RHD
genotype
phenotype
neonatal
noninvasive
fetal
MassARRAY
DNA

ClinicalTrials.gov processed this record on April 17, 2014