Clinical validation of fetal RHD genotyping in gestational week 11

Clinical validation of fetal RHD genotyping in gestational week 11 - Clinical validation of fetal RHD genotyping in gestational week 11

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON56198

Enrollment

1000

Registered

2023-02-02

Start date

2023-09-11

Completion date

Unknown

Last updated

2026-01-27

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

Conditions

Hemolytic disease of the fetus and newborn Rhesus disease

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

Exclusion criteria: Not applicable

Design outcomes

Primary

Measure	Time frame
Accuracy of fetal RHD genotyping in comparison to the reference standard as measured by the sensitivity, specificity, false negative rate, false positive rate, positive predictive value, negative predictive value, proportion of technical failures.	—

Countries

Netherlands

Contacts

Public ContactR.M. Oever

Leids Universitair Medisch Centrum

rhesusdstudie@sanquin.nl06-25270420

Outcome results