A Noninvasive Test for Fetal RHD Genotype

Completed

• Conditions: Rhesus D Genotype

• Registration Number: NCT00871195
• Lead Sponsor: Sequenom, Inc.

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.

Study Timeline

• Study First Submitted: 2009-03-26
• Study First Submitted QC: 2009-03-27
• Study First Posted: 2009-03-30
• Study Start: 2009-04
• Primary Completion: 2011-11
• Study Completion: 2012-04
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-09
• Last Update Posted: 2012-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 520

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To test as to whether advancing gestational age is associated with accuracy of fetal typing for RhD.	First, second, and third trimester

Trial Locations

Locations (12)

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States

University of British Columbia; 🇨🇦 Vancouver, British Columbia, Canada

Wayne State University; 🇺🇸 Detroit, Michigan, United States

Thomas Jefferson; 🇺🇸 Philadelphia, Pennsylvania, United States

Evergreen Hospital; 🇺🇸 Kirkland, Washington, United States

Columbia University; 🇺🇸 New York City, New York, United States

Obstetrix Medical Group of Phoenix; 🇺🇸 Phoenix, Arizona, United States

Good Samaritan Hospital; 🇺🇸 Cincinnati, Ohio, United States

McGill University; 🇨🇦 Montreal, Quebec, Canada

Mt. Sinai School of Medicine; 🇨🇦 Toronto, Ontario, Canada

Ohio State University; 🇺🇸 Columbus, Ohio, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States