Evaluation of a Noninvasive Fetal RHD Genotyping Test (IRIS)

Sequenom

Status: Completed

Conditions: Rhesus D Genotype

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT01054716

SQNM-RHD-105

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: Female

Ages: 18 to 64 years old

Volunteers: No 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