on- invasive prenatal diagnosis using cell-free fetal DNA (cffDNA) in maternal plasma

Completed

• Conditions: congenital anomalies; 10016849; down syndrome; 10027664

• Registration Number: NL-OMON36898
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 2250

Inclusion Criteria

Pregnant women who have chosen for an invasive prenatal diagnostic test
Vital pregnancy

Exclusion Criteria

patient is unable to understand information and give informede consent e.g. due to language barrier;
pregnant woman with chromosome anomaly;
age younger than 18 yrs

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>Feasability of non-invasive foetal aneuploidy testing in the UMCU, technical<br /><br>performance, technical failures, throughput, turnaround time and costs,<br /><br>sensitivity in a high risk population</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-Critical parameters influencing the amount of foetal DNA in the maternal<br /><br>plasma such as maternal weight, gestational age and obstetric complications</p><br>