Skip to main content
. 2017 Mar 15;2017(3):CD012599. doi: 10.1002/14651858.CD012599

Schuchter 2001.

Clinical features and settings Routine screening
Participants 9342 participants
Austria ‐ single institution
January 1994 to December 1998
Pregnant women
Mean maternal age 28 years (range 15‐46 years), 10.7% ≥ 35 years
10‐13 weeks' gestation
Study design Retrospective cohort
Target condition and reference standard(s) Down's syndrome: 19 cases
Reference standards: CVS (offered to patients with first trimester NT > 3.5 mm), amniocentesis (offered to patients with first trimester NT 2.5‐3.4, high risk on second trimester serum testing (> 1:250) and those > 35 years) or follow‐up to birth
Index and comparator tests Maternal age
First trimester NT (all women) (5‐MHz transducer, Acuson Corp)
Second trimester AFP, E2 and hGC (triple test) offered to patients not undergoing first trimester invasive testing (99.7% of women) (AMERLEX‐M 2nd Trimester kits, Ortho Clinical Diagnostics)
Follow‐up Patients included in study if they were delivered in the same hospital where they were screened. It is stated that all newborns were examined for malformations by a paediatrician after delivery
Aim of study To evaluate screening for trisomy 21 in a low risk population utilising a combination of NT measurement in the first trimester and the triple test in the second trimester
Test characteristics  
Reference standard used  
Notes Women having miscarriages were excluded from the study
Table of Methodological Quality
Item Authors' judgement Description
Representative spectrum? 
 All tests Yes Routine screening of typical pregnant population
Acceptable reference standard? 
 All tests Yes Karyotyping or follow‐up to birth
Partial verification avoided? 
 All tests Yes All women received a reference standard
Differential verification avoided? 
 All tests No Choice of reference standard depended on index test results
Incorporation avoided? 
 All tests Yes Reference standard was independent of the index test
Reference standard results blinded? 
 All tests No Reference standard interpreted with knowledge of index test results
Index test results blinded? 
 All tests Yes Index test interpreted without knowledge of reference standard results
Relevant clinical information? 
 All tests Yes Information available as would be in standard clinical practice
Uninterpretable results reported? 
 All tests No Details given for test failures/uninterpretable measurements
Withdrawals explained? 
 All tests No No details of withdrawals given