NonInvasive Prenatal Diagnosis - DNA TEsting on fetal Cells from the Cervix

NonInvasive Prenatal Diagnosis - DNA TEsting on fetal Cells from the Cervix - NIPD-DTECC

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON54115

Enrollment

150

Registered

2023-06-08

Start date

2023-07-10

Completion date

Unknown

Last updated

2025-09-29

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

Conditions

Congenital Abnormalities

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1) 18 years old or above. 2) Have an indication for CVS sampling or amniocentesis. 3) Pregnant with a gestational age between 10 and 22 weeks. 4) Signed written informed consent

Exclusion criteria

Exclusion criteria: 1) minder dan 24 uur de tijd tussen de momenten van het verkrijgen van de studie informatie en de CVS of vruchtwaterpunctie

Design outcomes

Primary

Measure	Time frame
1. Establishing a robust laboratory protocol for processing samples.	—

Secondary

Measure	Time frame
2. Sequential sampling of up to 100 samples, with as stopping criterion that less than 10 failures are observed in 100 samples. Failures are cases where less than 300 fetal cells are obtained admixed with no more than 60 maternal cells. 3. Quality and quantity of DNA for genetic testing using DTECC samples	—

Countries

Netherlands

Outcome results