Advanced prenatal screening in the first trimester of pregnancy: ADAM12 and PP13 as new screening markers for aneuploidy and adverse pregnancy outcome.

Withdrawn

• Conditions: Down syndrome; Trisomy 21; 10013995; 10010273

• Registration Number: NL-OMON31468
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 20000

Inclusion Criteria

Pregnant, singleton
Between 8-10 weeks gestation.

Exclusion Criteria

Multiple pregnancies.
Gestation more than 10 weeks.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>The goal of this study is to determine differences in screening performance<br /><br>expressed as detection rate (DR), false positive rate (FPR) and odds of being<br /><br>affected given a positive result (OAPR). This will be analysed for the combined<br /><br>test with and without ADAM-12. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Attention will be given to the fact if ADAM12 and PP13 have predictive value<br /><br>for adverse pregnancy outcome.</p><br>