Brizot 2001.
Clinical features and settings | Routine screening | |
Participants | 2996 participants Brazil ‐ University Hospital Estimated date of delivery pre December 1999 Pregnant women Median age 28 years (13‐46 years), 19.4% ≥ 35 years Singleton pregnancies 10‐14 weeks' gestation (mean 12 weeks) |
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Study design | Prospective cohort | |
Target condition and reference standard(s) | Down's syndrome: 10 cases Reference standards: antenatal karyotyping (5.9% of pregnancies: 62% of high‐risk, 29% of medium‐risk and 3% of the low‐risk women) or follow‐up to birth (85.3% of women) |
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Index and comparator tests | Maternal age First trimester (10‐14 weeks) NT Risk cut‐off 1:300 |
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Follow‐up | 85.3% of women were followed up to birth. Of these, 65 were spontaneous miscarriages or intrauterine death with no karyotyping | |
Aim of study | To assess the detection rate of chromosomal abnormalities using NT | |
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 |