Non-invasive prenatal diagnosis using cell-free fetal DNA in maternal plasma.

Non-invasive prenatal diagnosis using cell-free fetal DNA in maternal plasma. - Non-invasive prenatal diagnosis (NIPD)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON37584

Enrollment

6000

Registered

2012-05-14

Start date

2012-05-15

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

fetal genetic abnormalities including aneuploidies and recessive genetic disorders

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: All pregnant women planning to have prenatal screening or prenatal diagnosis as part of standard prenatal care are eligible to participate in this study (='patients'). Inclusion criteria: maternal age 18 years or older, vital pregnancy, able to understand the information and give informed consent.;Additionally male partners of participating pregnant women will be asked to participate in this study as well (='healthy volunteers'). Inclusion criteria: paternal age 18 years or older, partner of a pregnant woman participating in this study, able to understand the information and give informed consent.

Exclusion criteria

Exclusion criteria: Exclusion criterion: participant is unable to understand the information, e.g. due to a language barrier.

Design outcomes

Primary

Measure	Time frame
Technical performance: technical failures, throughput, turnaround time, cost Clinical performance: sensitivity, specificity and predictive values	—

Secondary

Measure	Time frame
Not applicable.	—

Countries

Netherlands

Outcome results