A Noninvasive Test for Fetal RHD Genotype

Completed

Conditions studied: Rhesus D Genotype

In brief

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.

Key facts

Study ID: NCT00871195
Run by: Sequenom, Inc.
People needed: 520
Starts: 2009-04-01
Expected to finish: 2012-04-01
Last updated by the study team: 2012-05-10

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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

Where it is running

Obstetrix Medical Group of Phoenix — Phoenix, Arizona, United States
Wayne State University — Detroit, Michigan, United States
Mt. Sinai School of Medicine — New York, New York, United States
Columbia University — New York, New York, United States
University of North Carolina — Chapel Hill, North Carolina, United States
Good Samaritan Hospital — Cincinnati, Ohio, United States
Ohio State University — Columbus, Ohio, United States
Thomas Jefferson — Philadelphia, Pennsylvania, United States
Baylor College of Medicine — Houston, Texas, United States
Evergreen Hospital — Kirkland, Washington, United States
University of British Columbia — Vancouver, British Columbia, Canada
Mt. Sinai School of Medicine — Toronto, Ontario, Canada
McGill University — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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