Evaluation of a Noninvasive Fetal RHD Genotyping Test

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01054716

Acronym

IRIS

Enrollment

500

Registered

2010-01-22

Start date

2009-05-31

Completion date

2010-11-30

Last updated

2011-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rhesus D Genotype

Keywords

RhD negative, RhD disease, fetal nucleic acid, fetal DNA, cell free fetal DNA, Fetal RHD genotype

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 64 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Fetal RHD determination from maternal whole blood	Between 10 and 28 weeks gestation

Countries

United States

Outcome results