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Changing diagnostic...
Changing diagnostic criteria for gestational diabetes (CDC4G) in Sweden : A stepped wedge cluster randomised trial
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- de Brun, Maryam, 1991- (författare)
- Örebro universitet,Institutionen för medicinska vetenskaper,Department of Obstetrics and Gynaecology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden
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- Magnuson, Anders (författare)
- Clinical Epidemiology and Biostatistics, School of Medical Sciences, Faculty of Medicine and Health, Örebro University, Örebro, Sweden
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- Montgomery, Scott, 1961- (författare)
- Örebro universitet,Institutionen för medicinska vetenskaper,Clinical Epidemiology and Biostatistics, School of Medical Sciences, Faculty of Medicine and Health, Örebro University, Örebro, Sweden; Clinical Epidemiology Division, Department of Medicine, Solna, Karolinska Institutet, Stockholm, Stockholm, Sweden; Department of Epidemiology and Public Health, University College London, London, United Kingdom
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- Patil, Snehal, 1986- (författare)
- Örebro universitet,Institutionen för medicinska vetenskaper,Clinical Epidemiology and Biostatistics, School of Medical Sciences, Faculty of Medicine and Health, Örebro University, Örebro, Sweden
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- Simmons, David, 1959- (författare)
- Örebro universitet,Institutionen för medicinska vetenskaper,School of Medical Science, Faculty of Medicine and Health, Örebro University, Örebro, Sweden; Macarthur Clinical School, Western Sydney University, Campbelltown, Australia
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- Berntorp, Kerstin (författare)
- Genetics and Diabetes Research Unit, Department of Clinical Sciences Malmö, Lund University, Malmö, Sweden
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- Jansson, Stefan P. O., 1959- (författare)
- Örebro universitet,Institutionen för medicinska vetenskaper,Region Örebro län,University Health Care Research Centre, Faculty of Medicine and Health, Örebro University, Örebro, Sweden
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- Wennerholm, Ulla-Britt (författare)
- Department of Obstetrics and Gynaecology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg and Region Västra Götaland, Sahlgrenska University Hospital, Department of Obstetrics and Gynecology, Gothenburg, Sweden
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- Wikström, Anna-Karin (författare)
- Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden; Uppsala University Hospital, Uppsala, Sweden
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- Strevens, Helen (författare)
- Department of Obstetrics and Gynaecology, Skåne University Hospital, Department of Clinical Sciences Lund, Lund University, Lund, Sweden
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- Ahlsson, Fredrik (författare)
- Department of Women's and Children's Health, Uppsala University; Uppsala University Hospital, Uppsala, Sweden
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- Sengpiel, Verena (författare)
- Department of Obstetrics and Gynaecology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg and Region Västra Götaland, Sahlgrenska University Hospital, Department of Obstetrics and Gynecology, Gothenburg, Sweden
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- Schwarcz, Erik (författare)
- Department of Medicine, Faculty of Medicine and Health, Örebro University, Örebro, Sweden
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- Storck-Lindholm, Elisabeth (författare)
- Department of Obstetrics and Gynaecology Södersjukhuset, Karolinska Institute, Solna, Sweden
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- Persson, Martina (författare)
- Department of Clinical Science and Education Karolinska Institute, Department of Medicine, Clinical Epidemiology Karolinska Institutet and Sachsska Childrens'and Youth Hospital Stockholm, Stockholm, Sweden
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- Petersson, Kerstin (författare)
- Umeå universitet,Obstetrik och gynekologi
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- Ryen, Linda, 1974- (författare)
- Örebro universitet,Institutionen för hälsovetenskaper,Region Örebro län,University Health Care Research Centre, Faculty of Medicine and Health, Örebro University, Örebro, Sweden
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- Ursing, Carina (författare)
- Department of Endocrinology and Diabetology, Södersjukhuset, Stockholm, Sweden
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- Hildén, Karin, 1978- (författare)
- Örebro universitet,Institutionen för medicinska vetenskaper,Region Örebro län,Department of Obstetrics and Gynaecology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden
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- Backman, Helena, 1965- (författare)
- Örebro universitet,Institutionen för hälsovetenskaper,Department of Obstetrics and Gynaecology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden
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(creator_code:org_t)
- Public Library of Science (PLoS), 2024
- 2024
- Engelska.
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Ingår i: PLoS Medicine. - : Public Library of Science (PLoS). - 1549-1277 .- 1549-1676. ; 21:7
- Relaterad länk:
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https://doi.org/10.1...
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https://umu.diva-por... (primary) (Raw object)
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https://urn.kb.se/re...
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https://doi.org/10.1...
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https://urn.kb.se/re...
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Abstract
Ämnesord
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- BACKGROUND: The World Health Organisation (WHO) 2013 diagnostic criteria for gestational diabetes mellitus (GDM) has been criticised due to the limited evidence of benefits on pregnancy outcomes in different populations when switching from previously higher glycemic thresholds to the lower WHO-2013 diagnostic criteria. The aim of this study was to determine whether the switch from previous Swedish (SWE-GDM) to the WHO-2013 GDM criteria in Sweden following risk factor-based screening improves pregnancy outcomes.METHODS AND FINDINGS: A stepped wedge cluster randomised trial was performed between January 1 and December 31, 2018 in 11 clusters (17 delivery units) across Sweden, including all pregnancies under care and excluding preexisting diabetes, gastric bypass surgery, or multifetal pregnancies from the analysis. After implementation of uniform clinical and laboratory guidelines, a number of clusters were randomised to intervention (switch to WHO-2013 GDM criteria) each month from February to November 2018. The primary outcome was large for gestational age (LGA, defined as birth weight >90th percentile). Other secondary and prespecified outcomes included maternal and neonatal birth complications. Primary analysis was by modified intention to treat (mITT), excluding 3 clusters that were randomised before study start but were unable to implement the intervention. Prespecified subgroup analysis was undertaken among those discordant for the definition of GDM. Multilevel mixed regression models were used to compare outcome LGA between WHO-2013 and SWE-GDM groups adjusted for clusters, time periods, and potential confounders. Multiple imputation was used for missing potential confounding variables. In the mITT analysis, 47 080 pregnancies were included with 6 882 (14.6%) oral glucose tolerance tests (OGTTs) performed. The GDM prevalence increased from 595/22 797 (2.6%) to 1 591/24 283 (6.6%) after the intervention. In the mITT population, the switch was associated with no change in primary outcome LGA (2 790/24 209 (11.5%) versus 2 584/22 707 (11.4%)) producing an adjusted risk ratio (aRR) of 0.97 (95% confidence interval 0.91 to 1.02, p = 0.26). In the subgroup, the prevalence of LGA was 273/956 (28.8%) before and 278/1 239 (22.5%) after the switch, aRR 0.87 (95% CI 0.75 to 1.01, p = 0.076). No serious events were reported. Potential limitations of this trial are mainly due to the trial design, including failure to adhere to guidelines within and between the clusters and influences of unidentified temporal variations.CONCLUSIONS: In this study, implementing the WHO-2013 criteria in Sweden with risk factor-based screening did not significantly reduce LGA prevalence defined as birth weight >90th percentile, in the total population, or in the subgroup discordant for the definition of GDM. Future studies are needed to evaluate the effects of treating different glucose thresholds during pregnancy in different populations, with different screening strategies and clinical management guidelines, to optimise women's and children's health in the short and long term.TRIAL REGISTRATION: The trial is registered with ISRCTN (41918550).
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Hälsovetenskap -- Folkhälsovetenskap, global hälsa, socialmedicin och epidemiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Health Sciences -- Public Health, Global Health, Social Medicine and Epidemiology (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Reproduktionsmedicin och gynekologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Obstetrics, Gynaecology and Reproductive Medicine (hsv//eng)
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- Av författaren/redakt...
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de Brun, Maryam, ...
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Magnuson, Anders
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Montgomery, Scot ...
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Patil, Snehal, 1 ...
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Simmons, David, ...
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Berntorp, Kersti ...
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visa fler...
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Jansson, Stefan ...
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Wennerholm, Ulla ...
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Wikström, Anna-K ...
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Strevens, Helen
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Ahlsson, Fredrik
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Sengpiel, Verena
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Schwarcz, Erik
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Storck-Lindholm, ...
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Persson, Martina
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Petersson, Kerst ...
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Ryen, Linda, 197 ...
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Ursing, Carina
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Hildén, Karin, 1 ...
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Backman, Helena, ...
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MEDICIN OCH HÄLS ...
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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PLoS Medicine
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Örebro universitet
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Umeå universitet