A Noninvasive Test for Fetal RHD Genotype
NAFTnet RHD
Evaluation Of The Performance Of A Noninvasive Test For Fetal RHD Genotype On The Sequenom MassARRAY System
1 other identifier
observational
520
2 countries
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2009
Typical duration for all trials
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2009
CompletedFirst Posted
Study publicly available on registry
March 30, 2009
CompletedStudy Start
First participant enrolled
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedMay 10, 2012
May 1, 2012
2.6 years
March 26, 2009
May 9, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To test as to whether advancing gestational age is associated with accuracy of fetal typing for RhD.
First, second, and third trimester
Eligibility Criteria
Pregnant women who are known to be serologically RhD negative.
You may qualify if:
- 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
You may not qualify if:
- RhD negative women known to be alloimmunized to the RhD antigen
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sequenom, Inc.lead
- NAFTNetcollaborator
Study Sites (13)
Obstetrix Medical Group of Phoenix
Phoenix, Arizona, 85006, United States
Wayne State University
Detroit, Michigan, 48201, United States
Mt. Sinai School of Medicine
New York, New York, 10029, United States
Columbia University
New York, New York, 10032, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Good Samaritan Hospital
Cincinnati, Ohio, 43210, United States
Ohio State University
Columbus, Ohio, 45211, United States
Thomas Jefferson
Philadelphia, Pennsylvania, 19107, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Evergreen Hospital
Kirkland, Washington, 98034, United States
University of British Columbia
Vancouver, British Columbia, V6H 3N1, Canada
Mt. Sinai School of Medicine
Toronto, Ontario, M5G 1X5, Canada
McGill University
Montreal, Quebec, H3A 1A1, Canada
Biospecimen
Plasma and buffy coat.
Study Officials
- PRINCIPAL INVESTIGATOR
Kenneth Moise, MD
Baylor College of Medicine
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2009
First Posted
March 30, 2009
Study Start
April 1, 2009
Primary Completion
November 1, 2011
Study Completion
April 1, 2012
Last Updated
May 10, 2012
Record last verified: 2012-05