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- de Brun, Maryam, 1991-, et al.
(författare)
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Changing diagnostic criteria for gestational diabetes (CDC4G) in Sweden : A stepped wedge cluster randomised trial
- 2024
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Ingår i: PLoS Medicine. - : Public Library of Science (PLoS). - 1549-1277 .- 1549-1676. ; 21:7
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Tidskriftsartikel (refereegranskat)abstract
- 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).
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- Fadl, Helena, 1965-, et al.
(författare)
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Changing diagnostic criteria for gestational diabetes in Sweden-a stepped wedge national cluster randomised controlled trial-the CDC4G study protocol
- 2019
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Ingår i: Bmc Pregnancy and Childbirth. - : Springer Science and Business Media LLC. - 1471-2393. ; 19:1
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Tidskriftsartikel (refereegranskat)abstract
- Background The optimal criteria to diagnose gestational diabetes mellitus (GDM) remain contested. The Swedish National Board of Health introduced the 2013 WHO criteria in 2015 as a recommendation for initiation of treatment for hyperglycaemia during pregnancy. With variation in GDM screening and diagnostic practice across the country, it was agreed that the shift to new guidelines should be in a scientific and structured way. The aim of the Changing Diagnostic Criteria for Gestational Diabetes (CDC4G) in Sweden () is to evaluate the clinical and health economic impacts of changing diagnostic criteria for GDM in Sweden and to create a prospective cohort to compare the many long-term outcomes in mother and baby under the old and new diagnostic approaches. Methods This is a stepped wedge cluster randomised controlled trial, comparing pregnancy outcomes before and after the switch in GDM criteria across 11 centres in a randomised manner. The trial includes all pregnant women screened for GDM across the participating centres during January-December 2018, approximately two thirds of all pregnancies in Sweden in a year. Women with pre-existing diabetes will be excluded. Data will be collected through the national Swedish Pregnancy register and for follow up studies other health registers will be included. Discussion The stepped wedge RCT was chosen to be the best study design for evaluating the shift from old to new diagnostic criteria of GDM in Sweden. The national quality registers provide data on the whole pregnant population and gives a possibility for follow up studies of both mother and child. The health economic analysis from the study will give a solid evidence base for future changes in order to improve immediate pregnancy, as well as long term, outcomes for mother and child.
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- Valgeirsdóttir, Inga Rós, 1984-, et al.
(författare)
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Metformin as treatment of GDM
- 2023
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Konferensbidrag (övrigt vetenskapligt/konstnärligt)abstract
- Background: Whether metformin should be used as treatment for gestational diabetes mellitus (GDM) is a matter of controversy. Concerns about the effects on neonatal birth weight (mainly small for gestational age, SGA) have been raised in one randomized controlled trial in type 2 diabetes in pregnancy. [1] The aim of this study was to evaluate pregnancy outcomes based on different GDM treatment modalities with focus on metformin.Methods: A cohort study, based on data from the stepped wedge cluster randomized trial; CDC4G (Changing diagnostic criteria for GDM in Sweden - www.cdc4g.se). Screening for GDM involved repeated random plasma glucose measurements and/or clinical risk factors. [2] Data were collected from electronic case record forms, and national health and quality registers. Singleton pregnancies during 2018 (last birth in August 2019) from eight clusters were included. Women with pregestational diabetes and/or previous gastric bypass surgery were excluded. Pregnancy outcomes for different treatment regimens were analyzed for women with GDM compared to the background population without GDM. Logistic regression analyzes with adjustments for confounders (body mass index, age, smoking, country of birth, chronic hypertensive disease and cluster) was performed (adjusted odds ratio (aOR) with 95% confidence interval (CI)) for all outcomes. Results: Of the 54 678 pregnancies included, 2 169 (4.0%) were diagnosed with GDM; of whom 1 076 (49.6%) were treated with diet only (dGDM), 668 (30.8%) with metformin only (mGDM), 116 (5.3%) with insulin only (iGDM), and 309 (14.2%) with both metformin and insulin (miGDM). Pregnancy outcomes were as follows: SGA (10th percentile) was significantly decreased in the mGDM group [aOR 0.57 (95% CI 0.41-0.79)] compared to the background population and no significant difference was found in the miGDM group [aOR 0.78 (95% CI 0.51-1.18)] compared to the background population. No significant difference in SGA (10th percentile) was found in the dGDM group [aOR 1.02 (CI 0.83-1.25)] compared to the background population. There was significant difference in neonates born large for gestational age (LGA, 90th percentile) in both mGDM and miGDM groups compared to the background population [aOR 2.29 (95% CI 1.88-2.78) and aOR 2.32 (95% CI 1.76-3.07), respectively]. There was not significant difference in LGA (90th percentile) in dGDM compared to the background population [aOR 0.90 (95% CI 0.73-1.12].Conclusions: These preliminary unpublished results show no increase in SGA for metformin treated GDM compared to the background population. Outcomes in the diet treated GDM group were similar to the background population. Further analyzes are needed to compare outcomes between pharmacologic treatment groups and assess whether specific treatment regimens lead to similar outcomes in different subgroups (eg ethnicity, obesity and glucose values on diagnostic oral glucose tolerance test).References:1.Feig DS, Donovan LE, Zinman B, Sanchez JJ, Asztalos E, Ryan EA, et al. Metformin in women with type 2 diabetes in pregnancy (MiTy): a multicentre, international, randomised, placebo-controlled trial. The lancet Diabetes & endocrinology. 2020;8(10):834-44.2.Fadl H, Saeedi M, Montgomery S, Magnuson A, Schwarcz E, Berntorp K, et al. Changing diagnostic criteria for gestational diabetes in Sweden - a stepped wedge national cluster randomised controlled trial - the CDC4G study protocol. BMC pregnancy and childbirth. 2019;19(1):398.
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