Evaluation of a Noninvasive Fetal RHD Genotyping Test

NCT ID: NCT01054716

Last Updated: 2011-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-11-30

Brief Summary

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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

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Conditions

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Rhesus D Genotype

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sequenom Center for Molecular Medicine

UNKNOWN

Sponsor Role collaborator

Sequenom, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sharp Grossmont Hospital

San Diego, California, United States

Site Status

West Coast OBGYN

San Diego, California, United States

Site Status

Women's Health Care, Inc

San Diego, California, United States

Site Status

Scripps Hospitals (5 San Diego locations)

San Diego, California, United States

Site Status

Spectrum Health Research

Grand Rapids, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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SQNM-RHD-105

Identifier Type: -

Identifier Source: org_study_id

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