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

Recruiting

• Conditions: fetal genetic abnormalities; including aneuploidies and recessive genetic disorders; 10083624; 10028920

• Registration Number: NL-OMON37584
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 6000

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

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Technical performance: technical failures, throughput, turnaround time, cost<br /><br>Clinical performance: sensitivity, specificity and predictive values</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable.</p><br>