Clinical trial NCT00871195: A Noninvasive Test for Fetal RHD Genotype
Official title: Evaluation Of The Performance Of A Noninvasive Test For Fetal RHD Genotype On The Sequenom MassARRAY System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhesus D Genotype
Keywords: Rhesus D
RHD
genotype
phenotype
neonatal
noninvasive
fetal
MassARRAY
DNA
Lead sponsor: Sequenom, Inc.
Sponsor class: INDUSTRY
Collaborators: name: NAFTNet
First posted: 2009-03-30
Enrollment: 520
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women who are known to be serologically RhD negative.

Brief summary: 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.

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 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

Primary outcomes:
measure: To test as to whether advancing gestational age is associated with accuracy of fetal typing for RhD.
timeFrame: First, second, and third trimester
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Obstetrix Medical Group of Phoenix
state: Arizona
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: New York City
country: United States
facility: Columbia University
state: New York
city: New York
country: United States
facility: Mt. Sinai School of Medicine
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Kirkland
country: United States
facility: Evergreen Hospital
state: Washington
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Toronto
country: Canada
facility: Mt. Sinai School of Medicine
state: Ontario
city: Montreal
country: Canada
facility: McGill University
state: Quebec
Study officials:
affiliation: Baylor College of Medicine
name: Kenneth Moise, MD
role: PRINCIPAL_INVESTIGATOR
References: