Clinical validation of fetal RHD genotyping in gestational week 27.

Clinical validation of fetal RHD genotyping in gestational week 27. - Clinical validation of fetal RHD genotyping in gestational week 27.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON54455

Enrollment

1000

Registered

2021-08-13

Start date

2022-01-15

Completion date

Unknown

Last updated

2025-03-17

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 Women should be eligible for the 27th gestational week (GW27) 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.	—

Secondary

Measure	Time frame
Not applicable.	—

Countries

Netherlands

Outcome results