Evaluation of a Noninvasive Fetal RHD Genotyping Test (IRIS)

September 1, 2011 updated by: Sequenom, Inc.
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92123
        • West Coast OBGYN
      • San Diego, California, United States, 91944
        • Sharp Grossmont Hospital
      • San Diego, California, United States, 92123
        • Women's Health Care, Inc
      • San Diego, California, United States, 92130
        • Scripps Hospitals (5 San Diego locations)
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant subjects who are RhD negative and between 10 and 28 weeks gestation.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fetal RHD determination from maternal whole blood
Time Frame: Between 10 and 28 weeks gestation
Between 10 and 28 weeks gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sequenom, Inc.

Collaborators

Sequenom Center for Molecular Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (ACTUAL)

November 1, 2010

Study Completion (ACTUAL)

November 1, 2010

Study Registration Dates

First Submitted

January 20, 2010

First Submitted That Met QC Criteria

January 21, 2010

First Posted (ESTIMATE)

January 22, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

September 5, 2011

Last Update Submitted That Met QC Criteria

September 1, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SQNM-RHD-105

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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