Clinical validation of fetal RHD genotyping in gestational week 27.

Recruiting

• Conditions: Hemolytic Disease of the Fetus and Newborn/Rhesus Disease; 10016849

• Registration Number: NL-OMON54455
• Lead Sponsor: Sanquin Diagnostiek B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 1000

Inclusion Criteria

Pregnant
RhD-negative
Women should be eligible for the 27th gestational week (GW27) pregnancy
screening.

Exclusion Criteria

Not applicable.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Accuracy of fetal RHD genotyping in comparison to the reference standard as<br /><br>measured by the sensitivity, specificity, false negative rate, false positive<br /><br>rate, positive predictive value, negative predictive value, proportion of<br /><br>technical failures.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable.</p><br>