Clinical validation of fetal RHD genotyping in gestational week 11

Recruiting

• Conditions: Hemolytic disease of the fetus and newborn/Rhesus disease; 10016849

• Registration Number: NL-OMON56198
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

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

Inclusion Criteria

Pregnant
RhD-negative multiparous
RhD-negative primigravida
Unknown RhD status in primigravida
Women should be able for the first trimester PSIE 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>