Rhesus D GenotypeNAFTnet RHDNCT00871195
A Noninvasive Test for Fetal RHD Genotype
An observational study of Rhesus D Genotype, run by Sequenom, Inc. at 13 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Rhesus D Genotype
- How many people
- 520 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Apr 2009to Apr 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women who are known to be serologically RhD negative.
Who may be able to join
- 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
Who cannot join
- RhD negative women known to be alloimmunized to the RhD antigen
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States10 sites
University of North Carolina
Chapel Hill, North Carolina, 27599
Good Samaritan Hospital
Cincinnati, Ohio, 43210
Ohio State University
Columbus, Ohio, 45211
Wayne State University
Detroit, Michigan, 48201
Baylor College of Medicine
Houston, Texas, 77030
Evergreen Hospital
Kirkland, Washington, 98034
Mt. Sinai School of Medicine
New York, New York, 10029
Columbia University
New York, New York, 10032
Thomas Jefferson
Philadelphia, Pennsylvania, 19107
Obstetrix Medical Group of Phoenix
Phoenix, Arizona, 85006
Canada3 sites
McGill University
Montreal, Quebec, H3A 1A1
Mt. Sinai School of Medicine
Toronto, Ontario, M5G 1X5
University of British Columbia
Vancouver, British Columbia, V6H 3N1
About this study
Official title: 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.
Read the 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.
- Conditions
- Rhesus D Genotype
- Keywords
- Rhesus D, RHD, genotype, phenotype, neonatal, noninvasive, fetal, MassARRAY, DNA
What is being measured
The primary outcome is the main question the study is designed to answer.
To test as to whether advancing gestational age is associated with accuracy of fetal typing for RhD.
Measured: First, second, and third trimester
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2009 (estimated)
- Study startApr 2009
- Primary completionNov 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhesus D GenotypeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 520 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sequenom, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NAFTNet
- Responsible party
- Sponsor
- Investigators
- Kenneth Moise, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00871195
- Sponsor's protocol ID
- SQNM-RHD-301
- Acronym
- NAFTnet RHD
- Status last verified
- May 2012
- First submitted
- 26 Mar 2009
- Last updated
- 10 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of The Performance Of A Noninvasive Test For Fetal RHD Genotype On The Sequenom MassARRAY System
- ClinicalTrials.gov ID
- NCT00871195
- Acronym / sponsor ID
- NAFTnet RHD / SQNM-RHD-301
- Conditions
- Rhesus D Genotype
- Keywords
- Rhesus D, RHD, genotype, phenotype, neonatal, noninvasive, fetal, MassARRAY
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 520 participants (actual)
- Lead sponsor
- Sequenom, Inc.Industry (pharma, biotech, devices)
- Collaborators
- NAFTNet
- Study start
- Apr 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 30 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women who are known to be serologically RhD negative.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- RhD negative women known to be alloimmunized to the RhD antigen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To test as to whether advancing gestational age is associated with accuracy of fetal typing for RhD.
Time frame: First, second, and third trimester
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2012.
Related trials for Rhesus D Genotype
Active, not recruitingObservational study
Prospective Collection of Whole Blood Specimens From RhD Negative Pregnant Women
Rhesus D Genotype, Pregnancy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Moise, MD principal investigator
Baylor College of Medicine
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhesus D Genotype, run by Sequenom, Inc. at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2012.