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KCE reports vol. 6A Prenatale zorg 191
Study Ref Population Intervention Outcomes Results Comments Study type EL
Saari-
Kemppainen et
al., 1994
(1 RCT, 11
cohort) from
1986 to 1996 in
Europe, USA
and Korea
4 [299] 9310 women
pregnant women
from two
hospitals in
Finland from
1986 to 1987
the clinical
effectiveness of
routine
ultrasound in
pregnancy
Routine early
ultrasound
between 16 to
20 weeks
gestation (n =
4691) vs.
selective
Sensitivity and
specificity of
detection with
ultrasound
Proportion of
structural
abnormalities
detected with
scan at less than
24 weeks
Termination of
pregnancy after
detection of
anatomical
malformations in
the fetus
Detection at less than
24 weeks: 41.3%
(range 15% to 71.5%)
and 99.9% (range
99.4% to 100%)
Detection at greater
than 24 weeks: 18.6%
(sensitivity only), range
18.2% to 21.7%
Overall detection rate:
44.7% (sensitivity only),
range 15.0% to 85.3%
Structural
abnormalities:
- Central nervous
system 76.4%
- Pulmonary 50%
- Cardiac 17.4%
- Gastrointestinal
41.9%
- Urinary tract
67.3%
- Skeletal 23.8%
Terminations: 11 vs. 0
(no p value reported)
Perinatal mortality
among singleton births:
4.2 vs. 8.0, p < 0.05
RCT 1b