Evaluation of a Noninvasive Fetal RHD Genotyping Test

Completed

• Conditions: Rhesus D Genotype

• Registration Number: NCT01054716
• Lead Sponsor: Sequenom, Inc.

Brief Summary

This study will collect whole blood samples from pregnant subjects who are RhD negative by serology to develop an assay for RHD determination of the fetus.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2010-01-20
• Study First Submitted QC: 2010-01-21
• Study First Posted: 2010-01-22
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-01
• Last Update Posted: 2011-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 500

Inclusion Criteria

• Subject is 18-64 years of age
• Subject is female
• Subject is pregnant
• Subject is RhD negative
• Subject is between 10 and 28 weeks gestation
• Subject provides informed consent
• Subject agrees to provide neonatal RHD and sex outcome

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fetal RHD determination from maternal whole blood	Between 10 and 28 weeks gestation

Trial Locations

Locations (5)

Sharp Grossmont Hospital; 🇺🇸 San Diego, California, United States

West Coast OBGYN; 🇺🇸 San Diego, California, United States

Women's Health Care, Inc; 🇺🇸 San Diego, California, United States

Scripps Hospitals (5 San Diego locations); 🇺🇸 San Diego, California, United States

Spectrum Health Research; 🇺🇸 Grand Rapids, Michigan, United States