Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Evaluation of a Noninvasive Fetal RHD Genotyping Test (IRIS)

This study has been completed.
Sequenom Center for Molecular Medicine
Information provided by (Responsible Party):
Sequenom, Inc. Identifier:
First received: January 20, 2010
Last updated: September 1, 2011
Last verified: September 2011

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.

Rhesus D Genotype

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Evaluation of a Noninvasive Fetal RHD Genotyping Test

Further study details as provided by Sequenom, Inc.:

Primary Outcome Measures:
  • Fetal RHD determination from maternal whole blood [ Time Frame: Between 10 and 28 weeks gestation ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood collected, processed to plasma and buffy coat for DNA extraction.

Estimated Enrollment: 500
Study Start Date: May 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01054716

United States, California
Scripps Hospitals (5 San Diego locations)
San Diego, California, United States, 92130
Sharp Grossmont Hospital
San Diego, California, United States, 91944
West Coast OBGYN
San Diego, California, United States, 92123
Women's Health Care, Inc
San Diego, California, United States, 92123
United States, Michigan
Spectrum Health Research
Grand Rapids, Michigan, United States, 49503
Sponsors and Collaborators
Sequenom, Inc.
Sequenom Center for Molecular Medicine
  More Information

No publications provided

Responsible Party: Sequenom, Inc. Identifier: NCT01054716     History of Changes
Other Study ID Numbers: SQNM-RHD-105
Study First Received: January 20, 2010
Last Updated: September 1, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Sequenom, Inc.:
RhD negative
RhD disease
fetal nucleic acid
fetal DNA
cell free fetal DNA
Fetal RHD genotype processed this record on February 27, 2015