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- Fadl, Helena, 1965-, et al.
(author)
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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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In: Bmc Pregnancy and Childbirth. - : Springer Science and Business Media LLC. - 1471-2393. ; 19:1
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Journal article (peer-reviewed)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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- Saeedi, Maryam, 1991-, et al.
(author)
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Characteristics of different risk factors and fasting plasma glucose for identifying GDM when using IADPSG criteria : a cross-sectional study
- 2018
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In: BMC Pregnancy and Childbirth. - : BioMed Central (BMC). - 1471-2393 .- 1471-2393. ; 18:1
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Journal article (peer-reviewed)abstract
- BACKGROUND: The Swedish National Board of Health and Welfare (SNBHW) recommended the new diagnostic criteria for GDM based upon Hyperglycaemia and Adverse Pregnancy Outcomes (HAPO) study thresholds. Due to limited knowledge base, no recommendations were made on GDM screening. The aim of this study is to evaluate test characteristics of risk factors and fasting blood glucose as screening tests for diagnosing GDM using diagnostic thresholds based upon HAPO study 1.75/2.0 (model I/II respectively) odds ratio for adverse pregnancy outcomes.METHODS: This cross-sectional, population-based study included all pregnant women who attended maternal health care in Örebro County, Sweden between the years 1994-96. A 75 g OGTT with capillary fasting and 2-h blood glucose was offered to all pregnant women at week 28-32. Risk factors and repeated random glucose samples were collected. Sensitivity, specificity and predictive values of blood glucose were calculated.RESULTS: Prevalence of GDM was 11.7% with model I and 7.2% with the model II criteria. Risk factors showed 28%, (95% CI 24-32) and 31%, (95% CI 25-37) sensitivity for model I and II respectively. A fasting cut off ≥4.8 mmol/l occurred in 24% of women with 91%, (95% CI 88-94) sensitivity and 85%, (95% CI 83-86) specificity using model I while a fasting cut off ≥5.0 mmol/l occurred in 14% with 91%, (95% CI 87-94) sensitivity and 92%, (95% CI 91-93) specificity using model II.CONCLUSION: Risk factor screening for GDM was found to be poorly predictive of GDM but fasting glucose of 4.8-5.0 mmol/l showed good test characteristics irrespective of diagnostic model and results in a low rate of OGTTs.
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- Saeedi, Maryam, 1991-, et al.
(author)
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Evaluation of screening methods for Gestational diabetes mellitus in Sweden
- 2017
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In: 49th Annual Meeting of the Diabetic Pregnancy Study Group. ; , s. 79-80
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Conference paper (other academic/artistic)abstract
- Introduction: The Swedish National Board of Health and Welfare (SNBHW) adopted the IADPSG criteria in 2015. However these criteria have not been implemented by the healthcare regions. In this cross-sectional, population-based study we evaluated the test characteristics of current screening methods in Sweden (risk factors or 2 hour OGTT) and different values of fasting blood glucose as indicators to perform an oral glucose tolerance test for diagnosing GDM. GDM is based on the IADPSG criteria (1.75 odds ratio (OR)) and HAPO data of 2.0 OR for adverse pregnancy outcomes.Method: Between 1994-1996 all pregnant women (n= 3616) in Örebro county were offered a 75 g oral glucose tolerance test with determination of fasting capillary blood glucose and 2-hour capillary blood glucose was used to diagnose GDM. Random blood glucose was measured four to six times during pregnancy. Data on traditional risk factors and BMI were registered during the maternal healthcare visits.Results: 15.5% women met the IDPSG criteria (1.75 OR) based on only two values in the OGTT, and 9.0% were diagnosed if using an OR of 2.0. Current screening methods in Sweden showed 33 % and 39 % sensitivity when using the IADPSG criteria and HAPO data of 2.0 OR, respectively. A fasting cut-off value of 4.8 mmol/l when using the IADPSG criteria (1.75 OR) showed 92 % sensitivity, 95 % specificity and occurred in 19% of the patients. A fasting cut-off value of 5.1 mmol/l when using the HAPO data of 2.0 OR showed 92 % sensitivity, 98 % specificity and occurred in 10% of the patients.Conclusion: Current screening methods for GDM screening in Sweden is poorly predictive of GDM according to the IADPSG criteria (1.75 OR) and HAPO data (2.0 OR), but fasting glucose showed good test characteristics and results in a lower rate of OGTTs.
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- Saeedi, Maryam, 1991-, et al.
(author)
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Increasing prevalence of Gestational Diabetes Mellitus when implementing the IADPSG criteria : a systematic review and meta-analysis
- 2021
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In: Diabetes Research and Clinical Practice. - : Elsevier. - 0168-8227 .- 1872-8227. ; 172
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Research review (peer-reviewed)abstract
- AIMS: Quantify the proportional increase in gestational diabetes (GDM) prevalence when implementing the new International Association of Diabetes and Pregnancy Study Groups (IADPSG) criteria compared to prior GDM criteria, and to assess risk factors that might affect the change in prevalence.METHODS: A systematic review and meta-analysis was performed of cohort and cross-sectional studies between January 1, 2010 to December 31, 2018 among pregnant women with GDM using IADPSG criteria compared to, and stratified by, old GDM criteria. Web of science, PubMed, EMBASE, Cochrane, Open Grey and Grey literature reports were included. The relative risk for each study was calculated. Subgroup analyses were performed by maternal age, body mass index, study design, country of publication, screening method, sampling method and data stratified according to diagnostic criteria.RESULTS: Thirty-one cohort and cross-sectional studies with 136 705 women were included. Implementing the IADPSG criteria was associated with a 75% (RR 1.75, 95% CI 1.53-2.01) increase in number of women with GDM with evidence of heterogeneity CONCLUSIONS: The IADPSG criteria increase the prevalence of GDM, but allow movement towards more homogeneity. More studies are needed of the benefits, harms, psychological effects and health costs of implementing the IADPSG criteria.
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- Saeedi, Maryam, 1991-, et al.
(author)
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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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Conference paper (peer-reviewed)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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