Evaluation of the FetoGnost RhD assay as non-invasive prenatal test for the determination of the fetal RhD Status (NIPT-RhD)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00025039

Enrollment

1200

Registered

2021-04-13

Start date

2021-04-27

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

O26

Interventions

Group 1: NIPT-RhD with FetoGnost RhD Group 2: NIPT-RhD with reference assay (in-house)

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: -at least 18 years old -RhD negative according to the maternal documents -pregnancy -at least 11 weeks of gestation -ability to give informed consent

Exclusion criteria

Exclusion criteria: -all persons who do not meet the inclusion criteria will be excluded. According to German guidelines multiple pregnancies are not eligible for targeted anti-D prophylaxis. However, multiple pregnancies are eligible for this study.

Design outcomes

Primary

Measure	Time frame
- Determination of the sensitivity of the FetoGnost RhD assay in comparison with the NIPT RhD reference with 95 % confidence intrval. - Determination of the specificity of the FetoGnost RhD assay in comparision with the NIPT RhD reference with 95 % confidence interval.	—

Secondary

Measure	Time frame
- Sensitivity of the FetoGnost RhD assay taking the newborn's serological RhD status as a reference. In case of discrepncy the molecular RhD status determined from the newborn's buccal swab is regarded a gold standard. - Specificity of the FetoGnost RhD assay taking the newborn's serological RhD status as a reference. In case of discrepncy the molecular RhD status determined from the newborn's buccal swab is regarded a gold standard. - Percentage of undetermined results. - Diagnositic sensitivity and specificity of the FetoGnost RhD assay in multiple pregnancies in comparison with singleton pregnancies. - Diagnosic sensitivity and specificity of the FetoGnost Kit RhD in the subgroups 11-19 weeks of gestation and >19 weeks of gestation.	—

Measure

Time frame

- Sensitivity of the FetoGnost RhD assay taking the newborn's serological RhD status as a reference. In case of discrepncy the molecular RhD status determined from the newborn's buccal swab is regarded a gold standard. - Specificity of the FetoGnost RhD assay taking the newborn's serological RhD status as a reference. In case of discrepncy the molecular RhD status determined from the newborn's buccal swab is regarded a gold standard. - Percentage of undetermined results. - Diagnositic sensitivity and specificity of the FetoGnost RhD assay in multiple pregnancies in comparison with singleton pregnancies. - Diagnosic sensitivity and specificity of the FetoGnost Kit RhD in the subgroups 11-19 weeks of gestation and >19 weeks of gestation.

—

Countries

Germany

Contacts

Public ContactTobias Legler

Universitätsmedizin Göttingen Abt. Transfusionsmedizin

tlegler@med.uni-goettingen.de0551-3965009

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026