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  • This contribution addresses the risk associated with exposure to statins during pregnancy. Design Multicentre observational prospective controlled study. Setting European Network of Teratology Information Services. Population Pregnant women who contacted one of 11 participating centres, seeking advice about exposure to statins during pregnancy, or to agents known to be nonteratogenic. Methods Pregnancies exposed during first trimester to statins were followed up prospectively, and their outcomes were compared with a matched control group. Main outcome measures Rates of major birth defects, live births, miscarriages, elective terminations, preterm deliveries and gestational age and birthweight at delivery. Results We collected observations from 249 exposed pregnancies and 249 controls. The difference in the rate of major birth defects between the statin-exposed and the control groups was small and statistically nonsignificant (4.1% versus 2.7% odds ratio [OR] 1.5; 9! 5% confidence interval [95% CI] 0.54.5, P=0.43). In an adjusted Cox model, the difference between miscarriage rates was also small and not significant (hazard ratio 1.36, 95% CI 0.632.93, P=0.43). Premature birth was more frequent in exposed pregnancies (16.1% versus 8.5%; OR 2.1, 95% CI 1.13.8, P=0.019). Nonetheless, median gestational age at birth (39weeks, interquartile range [IQR] 3740 versus 39weeks, IQR 3840, P=0.27) and birth weight (3280g, IQR 28353590 versus 3250g, IQR 28803630, P=0.95) did not differ between exposed and non-exposed pregnancies. Conclusions This study did not detect a teratogenic effect of statins. Its statistical power remains insufficient to challenge current recommendations of treatment discontinuation during pregnancy.
  • This contribution addresses the risk associated with exposure to statins during pregnancy. Design Multicentre observational prospective controlled study. Setting European Network of Teratology Information Services. Population Pregnant women who contacted one of 11 participating centres, seeking advice about exposure to statins during pregnancy, or to agents known to be nonteratogenic. Methods Pregnancies exposed during first trimester to statins were followed up prospectively, and their outcomes were compared with a matched control group. Main outcome measures Rates of major birth defects, live births, miscarriages, elective terminations, preterm deliveries and gestational age and birthweight at delivery. Results We collected observations from 249 exposed pregnancies and 249 controls. The difference in the rate of major birth defects between the statin-exposed and the control groups was small and statistically nonsignificant (4.1% versus 2.7% odds ratio [OR] 1.5; 9! 5% confidence interval [95% CI] 0.54.5, P=0.43). In an adjusted Cox model, the difference between miscarriage rates was also small and not significant (hazard ratio 1.36, 95% CI 0.632.93, P=0.43). Premature birth was more frequent in exposed pregnancies (16.1% versus 8.5%; OR 2.1, 95% CI 1.13.8, P=0.019). Nonetheless, median gestational age at birth (39weeks, interquartile range [IQR] 3740 versus 39weeks, IQR 3840, P=0.27) and birth weight (3280g, IQR 28353590 versus 3250g, IQR 28803630, P=0.95) did not differ between exposed and non-exposed pregnancies. Conclusions This study did not detect a teratogenic effect of statins. Its statistical power remains insufficient to challenge current recommendations of treatment discontinuation during pregnancy. (en)
Title
  • Pregnancy outcome following maternal exposure to statins: a multicentre prospective study
  • Pregnancy outcome following maternal exposure to statins: a multicentre prospective study (en)
skos:prefLabel
  • Pregnancy outcome following maternal exposure to statins: a multicentre prospective study
  • Pregnancy outcome following maternal exposure to statins: a multicentre prospective study (en)
skos:notation
  • RIV/00216208:11120/13:43906553!RIV13-MSM-11120___
http://linked.open...avai/riv/aktivita
http://linked.open...avai/riv/aktivity
  • P(LA08034)
http://linked.open...iv/cisloPeriodika
  • 4
http://linked.open...vai/riv/dodaniDat
http://linked.open...aciTvurceVysledku
http://linked.open.../riv/druhVysledku
http://linked.open...iv/duvernostUdaju
http://linked.open...titaPredkladatele
http://linked.open...dnocenehoVysledku
  • 98802
http://linked.open...ai/riv/idVysledku
  • RIV/00216208:11120/13:43906553
http://linked.open...riv/jazykVysledku
http://linked.open.../riv/klicovaSlova
  • multicentre prospective study; statins; maternal exposure; Pregnancy (en)
http://linked.open.../riv/klicoveSlovo
http://linked.open...odStatuVydavatele
  • US - Spojené státy americké
http://linked.open...ontrolniKodProRIV
  • [CB33DC346C69]
http://linked.open...i/riv/nazevZdroje
  • BJOG - An International Journal of Obstetrics and Gynaecology
http://linked.open...in/vavai/riv/obor
http://linked.open...ichTvurcuVysledku
http://linked.open...cetTvurcuVysledku
http://linked.open...vavai/riv/projekt
http://linked.open...UplatneniVysledku
http://linked.open...v/svazekPeriodika
  • 120
http://linked.open...iv/tvurceVysledku
  • Maňáková, Eva
http://linked.open...ain/vavai/riv/wos
  • 000314975000011
issn
  • 1470-0328
number of pages
http://bibframe.org/vocab/doi
  • 10.1111/1471-0528.12066
http://localhost/t...ganizacniJednotka
  • 11120
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