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Detection of malformations in chromosomally normal fetuses by routine ultrasound at 12 or 18 weeks of gestation - a randomised controlled trial in 39 572 pregnancies

Saltvedt, S ; Almstrom, H ; Kublickas, M ; Valentin, Lil LU orcid and Grunewald, C (2006) In BJOG: An International Journal of Obstetrics & Gynaecology 113(6). p.664-674
Abstract
Objective To compare the antenatal detection rate of malformations in chromosomally normal fetuses between a strategy of offering one routine ultrasound examination at 12 gestational weeks (gws) and a strategy of offering one routine examination at 18 gws. Design Randomised controlled trial. Setting Multicentre trial including eight hospitals. Population A total of 39 572 unselected pregnant women. Methods Women were randomised either to one routine ultrasound scan at 12 (12-14) gws including nuchal translucency (NT) measurement or to one routine scan at 18 (15-22) gws. Anomaly screening was performed in both groups following a check-list. A repeat scan was offered in the 12-week scan group if the fetal anatomy could not be adequately seen... (More)
Objective To compare the antenatal detection rate of malformations in chromosomally normal fetuses between a strategy of offering one routine ultrasound examination at 12 gestational weeks (gws) and a strategy of offering one routine examination at 18 gws. Design Randomised controlled trial. Setting Multicentre trial including eight hospitals. Population A total of 39 572 unselected pregnant women. Methods Women were randomised either to one routine ultrasound scan at 12 (12-14) gws including nuchal translucency (NT) measurement or to one routine scan at 18 (15-22) gws. Anomaly screening was performed in both groups following a check-list. A repeat scan was offered in the 12-week scan group if the fetal anatomy could not be adequately seen at 12-14 gws or if NT was >= 3.5 mm in a fetus with normal or unknown chromosomes. Main outcome measures Antenatal detection rate of malformed fetuses. Results The antenatal detection rate of fetuses with a major malformation was 38% (66/176) in the 12-week scan group and 47% (72/152) in the 18-week scan group (P = 0.06). The corresponding figures for detection at < 22 gws were 30% (53/176) and 40% (61/152) (P = 0.07). In the 12-week scan group, 69% of fetuses with a lethal anomaly were detected at a scan at 12-14 gws. Conclusions None of the two strategies for prenatal diagnosis is clearly superior to the other. The 12-week strategy has the advantage that most lethal malformations will be detected at < 15 gws, enabling earlier pregnancy termination. The 18-week strategy seems to be associated with a slightly higher detection rate of major malformations, although the difference was not statistically significant. (Less)
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author
; ; ; and
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
ultrasonography, screening, prenatal diagnosis, abnormalities, prenatal, ultrasound
in
BJOG: An International Journal of Obstetrics & Gynaecology
volume
113
issue
6
pages
664 - 674
publisher
Wiley-Blackwell
external identifiers
  • wos:000238357600006
  • pmid:16709209
  • scopus:33646889964
ISSN
1471-0528
DOI
10.1111/j.1471-0528.2006.00953.x
language
English
LU publication?
yes
id
caac6270-519d-4897-8dda-13da306e6028 (old id 406273)
date added to LUP
2016-04-01 15:50:56
date last changed
2020-10-07 04:18:17
@article{caac6270-519d-4897-8dda-13da306e6028,
  abstract     = {Objective To compare the antenatal detection rate of malformations in chromosomally normal fetuses between a strategy of offering one routine ultrasound examination at 12 gestational weeks (gws) and a strategy of offering one routine examination at 18 gws. Design Randomised controlled trial. Setting Multicentre trial including eight hospitals. Population A total of 39 572 unselected pregnant women. Methods Women were randomised either to one routine ultrasound scan at 12 (12-14) gws including nuchal translucency (NT) measurement or to one routine scan at 18 (15-22) gws. Anomaly screening was performed in both groups following a check-list. A repeat scan was offered in the 12-week scan group if the fetal anatomy could not be adequately seen at 12-14 gws or if NT was &gt;= 3.5 mm in a fetus with normal or unknown chromosomes. Main outcome measures Antenatal detection rate of malformed fetuses. Results The antenatal detection rate of fetuses with a major malformation was 38% (66/176) in the 12-week scan group and 47% (72/152) in the 18-week scan group (P = 0.06). The corresponding figures for detection at &lt; 22 gws were 30% (53/176) and 40% (61/152) (P = 0.07). In the 12-week scan group, 69% of fetuses with a lethal anomaly were detected at a scan at 12-14 gws. Conclusions None of the two strategies for prenatal diagnosis is clearly superior to the other. The 12-week strategy has the advantage that most lethal malformations will be detected at &lt; 15 gws, enabling earlier pregnancy termination. The 18-week strategy seems to be associated with a slightly higher detection rate of major malformations, although the difference was not statistically significant.},
  author       = {Saltvedt, S and Almstrom, H and Kublickas, M and Valentin, Lil and Grunewald, C},
  issn         = {1471-0528},
  language     = {eng},
  number       = {6},
  pages        = {664--674},
  publisher    = {Wiley-Blackwell},
  series       = {BJOG: An International Journal of Obstetrics & Gynaecology},
  title        = {Detection of malformations in chromosomally normal fetuses by routine ultrasound at 12 or 18 weeks of gestation - a randomised controlled trial in 39 572 pregnancies},
  url          = {http://dx.doi.org/10.1111/j.1471-0528.2006.00953.x},
  doi          = {10.1111/j.1471-0528.2006.00953.x},
  volume       = {113},
  year         = {2006},
}