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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
History of Changes

March 26, 2009
May 9, 2012
April 2009
November 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00871195 on ClinicalTrials.gov Archive Site
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A Noninvasive Test for Fetal RHD Genotype
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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Plasma and buffy coat.
Probability Sample

Pregnant women who are known to be serologically RhD negative.
Rhesus D Genotype
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
520
April 2012
November 2011   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00871195
SQNM-RHD-301
No
Sequenom, Inc.
Sequenom, Inc.
NAFTNet
Principal Investigator: Kenneth Moise, MD Baylor College of Medicine
Sequenom, Inc.
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP