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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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- Hildén, Karin, 1978-, et al.
(författare)
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Born over 4500 g : the trends in birth trauma and mode of delivery in women with GDM and type 1 diabetes in Sweden between 1998-2012
- 2018
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Konferensbidrag (refereegranskat)abstract
- Background: We have previously shown that during the years 1998-2012, the overall incidence of LGA and birthweight decreased in both women with and without GDM in Sweden, and unpublished preliminary results show that there is a converse trend among women with T1DM. The incidence of Erbs palsy also decreased in the GDM and background population, but remained unchanged for women with T1DM. Since macrosomia is one of the most prominent risk factors for Erb´s palsy and delivery complications, the aim of the study was to evaluate trends in incidence of Erb´s palsy and delivery mode in the macrosomic group defined as weight ≥4500g and we present here our preliminary results.Method: This is a cohort study in Sweden 1998-2012 , including singleton macrosomic (≥4500 g) births. Vaginal deliveries were selected for the analyses relating to Erb´s plasy. Poisson regression was used to evaluate trends per year in both the GDM, T1DM and the background population. Results were partly stratified on BMI, to be able to detect any group differences in trends. P-value of <0.05 was considered statistically significant.Results: In total there were 57 2015 macrosomic infants, of whom (n= 36 933, 64,6%) were delivered vaginally. Of these, only 2.1 % (n=798) were vaginally delivered by women with GDM, (1.4%) type 2 diabetes (0.1%) or T1DM (0.7%). The trend in Erb´s palsy decreased significantly in the background population at a rate of OR 0.954 (95% CI 0.936-0.973) per year. For women with GDM or T1DM there was no significant change in incidence of trends over these years for Erb´s palsy. As for Caesarean section (CS) there was a significant increase per year for GDM pregnancies (OR 1.028, 95% CI 1.007-1.049) and in the background population (1.018 95% CI 1.013-1.022). No change was seen for CS in pregnancies with T1DM.Conclusion: Even though the rates of LGA and birthweight have decreased in Sweden over this time period for women with GDM and the background population, we could not see a significant decrease in Erb´s palsy among women with vaginal births in either the GDM group or for women with T1DM in the macrosomic infants. However, a decrease was seen in the incidence of Erb´s palsy in the macrosomic babies in the background population. The rates of CS have significantly increased in the background population and for GDM pregnancies, but been stable for T1DM. We conclude that the disparity in risk of Erbs has grown over this time period. Further work is needed to ascertain whether this is due to the need for improved surveillance, a higher CS rate, and/or improved glycaemic management (or other factors).
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- Saeedi, Maryam, 1991-, et al.
(författare)
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The CDC4G trial : Impact of Changing Diagnostic Criteria for Gestational diabetes in Sweden – a stepped wedge national cluster randomised controlled trial-study protocol
- 2018
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Konferensbidrag (refereegranskat)abstract
- Introduction: In 2013 WHO recommended new criteria for GDM, defined as ≥5.1, ≥10.0 and/or ≥8.5 mmol/l fasting, 1 hour and/or 2 hour cut offs, which the Swedish National Board of Health adopted. With the current variation in GDM screening/diagnostic practice across Sweden and the debate over the criteria, we have established a stepped wedge cluster randomised controlled trial (SW-CRCT) to move towards a unified approach to GDM management. The objectives for the Changing Diagnostic Criteria for Gestational diabetes in Sweden (CDC4G) trial include: (1) To compare the rates of adverse neonatal and maternal outcomes before and after the change in GDM diagnostic criteria (2) To compare the health costs before and after the change and assess the net cost/saving (3)To compare the adverse outcomes and health costs using the new WHO criteria (75% excess risk) and the criteria based upon the 100% excess risk of neonatal adverse outcomes; using the national pregnancy register where all data needed is registered from the medical journals. The aim of this study is to describe the development of the study and the associated key issues.Methods: The CDC4G study is a national prospective, unblinded, SW-CRCT of the switch from pre-existing Swedish diagnostic criteria to the WHO 2013 criteria for GDM. Each participating centre constitutes one cluster, in which the patients undergo screening for GDM following their usual approach. The time of switch to the new criteria is randomized and subsequently rolled out until all clusters (centres) have received the intervention (introduction of the new GDM regimens) during 2018. All women treated in the participating clusters (including within primary care and hospitals) will be included in the study. Women with preexisting diabetes and overt diabetes are excluded. The key issues were identification of primary outcome, recruitment of sites and undertaking the power calculation.The study is approved by the Uppsala –Örebro regional ethics board, Dnr: 2016/487.Result: Identification of outcomes: As many women with GDM are not identified in the pre-switch period, measures that could be influenced by knowing the diagnosis (eg screening for neonatal hypoglycaemia) were excluded. The measure also needed to be frequent enough to have a large enough absolute reduction to be detected in the total obstetric population. As LGA is common (10% total population, 20% in GDM), it was decided that LGA should be primary outcome. Secondary maternal and neonate outcomes and health economic outcomes will also be evaluated. Recruitment of sites: Regions/clinics adopted the same protocols and hence were taken as ‘clusters’. There are 21 regions in Sweden and 38 clinics with annual births ranging between 540 and 10 200 births. Stockholm regions overlap so were taken as one cluster (5 clinics) . Overall 11/21 regions with 67000 births per annum agreed to participate. Annual births in Sweden is 95-100 000/year. Power calculation: With 11 clinics (clusters) participating and an intra cluster correlation of 0.0026 a minimum sample size of 47916 pregnant women (23958 before change and 23958 after change of the new GDM criteria) have 90% statistical power to detect a risk reduction of LGA by 1.5% on a population level (from 10% to 8.5%). The power calculation incorporates consideration of the varying sizes in cluster.Discussion: Establishing a national randomised controlled trial to evaluate the impact of the WHO 2013 criteria raised several challenges, which have now been addressed. The trial has commenced and final results of the study will be analyzed and disseminated in 2019 (www.cdc4g.com).Trial registration CDC4G is listed on the ISRCTN registry with study ID ISRCTN41918550 (15/12/2017).
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| 5. |
- Valgeirsdottir, Inga-Ros, et al.
(författare)
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Diet as treatment for GDM : enough for improving outcomes?
- 2018
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Konferensbidrag (refereegranskat)abstract
- Introduction: We wanted to compare the excess risk of adverse maternal and neonatal outcomes for women with diet (d-GDM) and insulin treated gestational diabetes (GDM) (i-GDM) in Sweden.Methods: A population based cohort study including all singleton pregnancies without pre-existing diabetes recorded in the Swedish Medical Birth Register between 1998 and 2012. Logistic regression analyses were used to adjust for confounders (BMI, age, smoking, country of birth and chronic hypertension). The adjusted odds ratio (aOR) with 95% confidence interval (CI) for maternal and neonatal outcomes are presented.Results: A total of 1,441,338 singleton pregnancies were included: 14,242 women were diagnosed with GDM (1.0%), 8,851 (62.1%) d-GDM and 5,391 (37.9%) i-GDM . Mean BMI was significantly higher than background in both groups (27.8 ± 6.0 and 30.3 ± 6.5 kg/m2 in the d-GDM group and i-GDM group, respectively, vs 24.5 ± 4.4 kg/m2, both p < 0.001). The d-GDM group had significantly higher risk for preeclampsia [aOR 1.71 (95% CI 1.55-1.88)], cesarean section [aOR 1.18 (95% CI 1.11-1.25)], LGA infants [aOR 1.85 (95% CI 1.75-1.96)] and birth injury/trauma [aOR 1.88 (95% CI 1.37-2.58)] compared to the background population. The risk was even higher in the i-GDM group, preeclampsia [aOR 2.11 (95% CI 1.88-2.36)], cesarean section [aOR 1.84 (95% CI 1.73-1.96)], LGA infants [aOR 3.38 (95% CI 3.17-3.60)] and birth injury/trauma [aOR 2.26 (95% CI 1.61-3.20)].Conclusions: Adverse outcomes in the d-GDM group were higher than the background population and higher still among those with i-GDM.
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