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  • de Brun, Maryam,1991-Örebro universitet,Institutionen för medicinska vetenskaper,Department of Obstetrics and Gynaecology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden (författare)

Changing diagnostic criteria for gestational diabetes (CDC4G) in Sweden : A stepped wedge cluster randomised trial

  • Artikel/kapitelEngelska2024

Förlag, utgivningsår, omfång ...

  • Public Library of Science (PLoS),2024
  • printrdacarrier

Nummerbeteckningar

  • LIBRIS-ID:oai:DiVA.org:oru-114706
  • https://urn.kb.se/resolve?urn=urn:nbn:se:oru:diva-114706URI
  • https://doi.org/10.1371/journal.pmed.1004420DOI
  • https://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-227891URI

Kompletterande språkuppgifter

  • Språk:engelska
  • Sammanfattning på:engelska

Ingår i deldatabas

Klassifikation

  • Ämneskategori:ref swepub-contenttype
  • Ämneskategori:art swepub-publicationtype

Anmärkningar

  • Funding: Swedish Research Council (https://www.vr.se/english.html) HB, 2018-00470 ALF Funding Region Örebro County (HB) OLL-930268 The Swedish state under the agreement between the Swedish government and the county councils, the ALF-agreement , (VS), GBG-823211, ALFGBG-932692 Nyckelfonden,Region Örebro County, HB), OLL-597601 Region Örebro County Research committee (HB), OLL-693551, OLL-786911 Regional Research committee Uppsala-Örebro (HB), RFR-749241 Stiftelsen Mary von Sydows, född Wijk, donation fund, (VS), numbers 1017, 4917, 2618, and 3718) Clinical therapy research, Region Stockholm County, The Centre of Clinical Research, (ESL), Västmanland County Council, (MdB), LTV-966501 Research Funds of Skåne University Hospital and the Skåne County Council Research and Development Foundation (KB), REGSKANE-622891.
  • 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 och genrebeteckningar

Biuppslag (personer, institutioner, konferenser, titlar ...)

  • Magnuson, AndersClinical Epidemiology and Biostatistics, School of Medical Sciences, Faculty of Medicine and Health, Örebro University, Örebro, Sweden (författare)
  • Montgomery, Scott,1961-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(Swepub:oru)smy (författare)
  • Patil, Snehal,1986-Örebro universitet,Institutionen för medicinska vetenskaper,Clinical Epidemiology and Biostatistics, School of Medical Sciences, Faculty of Medicine and Health, Örebro University, Örebro, Sweden(Swepub:oru)slpl (författare)
  • Simmons, David,1959-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(Swepub:oru)dss (författare)
  • Berntorp, KerstinGenetics and Diabetes Research Unit, Department of Clinical Sciences Malmö, Lund University, Malmö, Sweden (författare)
  • Jansson, Stefan P. O.,1959-Örebro universitet,Institutionen för medicinska vetenskaper,Region Örebro län,University Health Care Research Centre, Faculty of Medicine and Health, Örebro University, Örebro, Sweden(Swepub:oru)sfjn (författare)
  • Wennerholm, Ulla-BrittDepartment 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 (författare)
  • Wikström, Anna-KarinDepartment of Women's and Children's Health, Uppsala University, Uppsala, Sweden; Uppsala University Hospital, Uppsala, Sweden (författare)
  • Strevens, HelenDepartment of Obstetrics and Gynaecology, Skåne University Hospital, Department of Clinical Sciences Lund, Lund University, Lund, Sweden (författare)
  • Ahlsson, FredrikDepartment of Women's and Children's Health, Uppsala University; Uppsala University Hospital, Uppsala, Sweden (författare)
  • Sengpiel, VerenaDepartment 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 (författare)
  • Schwarcz, ErikDepartment of Medicine, Faculty of Medicine and Health, Örebro University, Örebro, Sweden (författare)
  • Storck-Lindholm, ElisabethDepartment of Obstetrics and Gynaecology Södersjukhuset, Karolinska Institute, Solna, Sweden (författare)
  • Persson, MartinaDepartment of Clinical Science and Education Karolinska Institute, Department of Medicine, Clinical Epidemiology Karolinska Institutet and Sachsska Childrens'and Youth Hospital Stockholm, Stockholm, Sweden (författare)
  • Petersson, KerstinUmeå universitet,Obstetrik och gynekologi(Swepub:umu)kepe0013 (författare)
  • Ryen, Linda,1974-Örebro universitet,Institutionen för hälsovetenskaper,Region Örebro län,University Health Care Research Centre, Faculty of Medicine and Health, Örebro University, Örebro, Sweden(Swepub:oru)ldrn (författare)
  • Ursing, CarinaDepartment of Endocrinology and Diabetology, Södersjukhuset, Stockholm, Sweden (författare)
  • Hildén, Karin,1978-Örebro universitet,Institutionen för medicinska vetenskaper,Region Örebro län,Department of Obstetrics and Gynaecology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden(Swepub:oru)knhn (författare)
  • Backman, Helena,1965-Örebro universitet,Institutionen för hälsovetenskaper,Department of Obstetrics and Gynaecology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden(Swepub:oru)hfl (författare)
  • Örebro universitetInstitutionen för medicinska vetenskaper (creator_code:org_t)

Sammanhörande titlar

  • Ingår i:PLoS Medicine: Public Library of Science (PLoS)21:71549-12771549-1676

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