{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T02:16:46Z","timestamp":1789611406996,"version":"build-2803163510"},"update-to":[{"DOI":"10.1371\/journal.pmed.1004420","type":"new_version","label":"New version","source":"publisher","updated":{"date-parts":[[2024,7,22]],"date-time":"2024-07-22T00:00:00Z","timestamp":1721606400000}}],"reference-count":42,"publisher":"Public Library of Science (PLoS)","issue":"7","license":[{"start":{"date-parts":[[2024,7,8]],"date-time":"2024-07-08T00:00:00Z","timestamp":1720396800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100004359","name":"Swedish Research Council","doi-asserted-by":"crossref","award":["Clinical therapy research (2018\u201300470)"],"award-info":[{"award-number":["Clinical therapy research (2018\u201300470)"]}],"id":[{"id":"10.13039\/501100004359","id-type":"DOI","asserted-by":"crossref"}]},{"name":"ALF Funding Region \u00d6rebro County","award":["OLL-930268"],"award-info":[{"award-number":["OLL-930268"]}]},{"name":"ALF Funding Gothenburg","award":["GBG-823211, ALFGBG-932692"],"award-info":[{"award-number":["GBG-823211, ALFGBG-932692"]}]},{"DOI":"10.13039\/501100023670","name":"Nyckelfonden","doi-asserted-by":"publisher","award":["OLL 597601"],"award-info":[{"award-number":["OLL 597601"]}],"id":[{"id":"10.13039\/501100023670","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100009228","name":"Region \u00d6rebro l\u00e4n","doi-asserted-by":"publisher","award":["OLL 693551, OLL-786911"],"award-info":[{"award-number":["OLL 693551, OLL-786911"]}],"id":[{"id":"10.13039\/501100009228","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100019032","name":"Regionala Forskningsr\u00e5det Uppsala\/\u00d6rebro","doi-asserted-by":"publisher","award":["RFR 749241"],"award-info":[{"award-number":["RFR 749241"]}],"id":[{"id":"10.13039\/100019032","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100014197","name":"Stiftelsen Mary von Sydows, f\u00f6dd Wijk, donationsfond","doi-asserted-by":"publisher","award":["1017,4917,2618 and 3718"],"award-info":[{"award-number":["1017,4917,2618 and 3718"]}],"id":[{"id":"10.13039\/501100014197","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Clinical therapy research, Region Stockholm County"},{"DOI":"10.13039\/501100009612","name":"Landstinget V\u00e4stmanland","doi-asserted-by":"publisher","award":["LTV-966501"],"award-info":[{"award-number":["LTV-966501"]}],"id":[{"id":"10.13039\/501100009612","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Research fund of Sk\u00e5ne University Hospital","award":["REGSKANE-622891"],"award-info":[{"award-number":["REGSKANE-622891"]}]}],"content-domain":{"domain":["www.plosmedicine.org"],"crossmark-restriction":false},"short-container-title":["PLoS Med"],"abstract":"<jats:sec id=\"sec001\">\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec002\">\n                    <jats:title>Methods and findings<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                    <jats:p>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 &gt;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.<\/jats:p>\n                    <jats:p>\n                      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,\n                      <jats:italic>p<\/jats:italic>\n                      = 0.26).\n                    <\/jats:p>\n                    <jats:p>\n                      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,\n                      <jats:italic>p<\/jats:italic>\n                      = 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.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec003\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>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 &gt;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\u2019s and children\u2019s health in the short and long term.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec004\">\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>\n                      The trial is registered with ISRCTN (\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.isrctn.com\/ISRCTN41918550\" xlink:type=\"simple\">41918550<\/jats:ext-link>\n                      ).\n                    <\/jats:p>\n                  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