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

Benattar 1999.

Clinical features and settings Routine screening
Participants 1656 participants
France ‐ single centre
January to December 1995
Pregnant women
Singleton pregnancies
Mean maternal age 32 years (range 16‐46 years)
Enrolled before 13 weeks' gestation
Study design Prospective cohort
Target condition and reference standard(s) Down's syndrome: 5 cases
Reference standards: amniocentesis due to maternal age > 38 years (6.1% or women). Karyotyping encouraged for women with positive result on 1 or more index test. No details of reference standard for index test negative women
Index and comparator tests Maternal age
NT at 12‐14 weeks (Toshiba SSA 270), cut‐point 1:250
First trimester (12‐14 weeks) serum AFP and free ßhCG (Elsa AFP and Elsa free BhCG; Cis‐Bio International)
Second trimester (15‐18 weeks) serum AFP and total hCG (AFP‐2T and hCG‐60; Ortho‐Clinical Diagnostics)
All women had NT and serum testing
Follow‐up Details of follow‐up not reported. 12 patients were lost to follow‐up due to miscarriages
Aim of study To evaluate the sequential combination of ultrasound screening for fetal aneuploidy at 11‐14 weeks with maternal biochemistry at 12‐14 and 15‐18 weeks of gestation
Test characteristics  
Reference standard used  
Notes  
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 Unclear Unclear if 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 No details given for test failures/uninterpretable measurements
Withdrawals explained? 
 All tests No No details of withdrawals given