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 |
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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 |
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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 |
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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 |