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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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| 2. |
- Fadl, Helena E., 1965-, et al.
(författare)
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Maternal and neonatal outcomes and time trends of gestational diabetes mellitus in Sweden from 1991 to2003
- 2010
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Ingår i: Diabetic Medicine. - Malden 02148, MA USA : Wiley-Blackwell. - 0742-3071 .- 1464-5491. ; 27:4, s. 436-441
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Tidskriftsartikel (refereegranskat)abstract
- Aims To determine maternal and neonatal outcomes for women with gestational diabetes mellitus (GDM) in Sweden during 1991–2003, and to compare the outcomes in the two time periods.Methods This is a population-based cohort study using the Swedish Medical Birth Register data for the period 1991–2003. There were 1 260 297 women with singleton pregnancies registered during this time, of whom 10 525 were diagnosed with GDM, based on a 75 g oral glucose tolerance test. The main diagnostic criteria were fasting capillary whole blood glucose ≥ 6.1 mmol⁄l and 2 h blood glucose ≥ 9.0 mmol⁄l.Results Maternal characteristics differed significantly between the GDM and non-GDM group. Adjusted odds ratios (OR) were as follows: for pre-eclampsia, 1.81 (95% confidence interval (CI) 1.64–2.00); for shoulder dystocia, 2.74 (2.04–3.68); and for Caesarean section, 1.46 (1.38–1.54).No difference was seen in perinatal mortality, stillbirth rates, Apgar scores, fetal distress or transient tachypnoea. There was a markedly higher risk of large for gestational age,OR3.43 (3.21–3.67), and Erb’s palsy, OR 2.56 (1.96–3.32), in the GDMgroup, and statistically significant differences in prematurity < 37 weeks, birthweight > 4.5 kg, and major malformation, OR 1.19–1.71. No statistically significant improvement in outcomes was seen between the two study periods.Conclusions Women with GDM have higher risks of pre-eclampsia, shoulder dystocia and Caesarean section. Their infants are often large for gestational age and have higher risks of prematurity, Erb’s palsy and major malformations. These outcomes did not improve over time.
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| 3. |
- Fadl, Helena E., 1965-, et al.
(författare)
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Randomized controlled study in pregnancy on treatment of marked hyperglycemia that is short of overt diabetes
- 2015
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Ingår i: Acta Obstetricia et Gynecologica Scandinavica. - : Wiley-Blackwell. - 0001-6349 .- 1600-0412. ; 94:11, s. 1181-1187
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: A randomized multicenter study was conducted in the Stockholm-orebro areas in Sweden to evaluate how treatment aiming at normoglycemia affects fetal growth, pregnancy and neonatal outcome in pregnant women with severe hyperglycemia.Material and methods: Pregnant women with hyperglycemia defined as fasting capillary plasma glucose <7.0 mmol/L and a two-hour plasma glucose value 10.0 and <12.2 mmol/L following a 75-g oral glucose tolerance test (OGTT) diagnosed before 34 weeks of gestation were randomized to treatment (n=33) or controls (n=36). Women assigned to the control group were blinded for the OGTT results and received routine care. The therapeutic goal was fasting plasma glucose 4-5 mmol/L, and <6.5 mmol/L after a meal. Primary outcomes were size at birth and number of large-for-gestational age (>90th percentile) neonates. Secondary outcomes were pregnancy complications, neonatal morbidity and glycemic control.Results: The planned number of participating women was not reached. There was a significantly reduced rate of large-for-gestational age neonates, 21 vs. 47%, P<0.05. Group differences in pregnancy complications and neonatal morbidity were not detected because of limited statistical power. In total, 66.7% of the women in the intervention group received insulin. Of all measured plasma glucose values, 64.1% were in the target range, 7.2% in the hypoglycemic range and 28.7% above target values. There were no cases of severe hypoglycemia.Conclusions: Aiming for normalized glycemia in a pregnancy complicated by severe hyperglycemia reduces fetal growth but is associated with an increased rate of mild hypoglycemia.
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| 4. |
- Fadl, Helena E., 1965-, et al.
(författare)
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Trends in diabetes in pregnancy in Sweden 1998-2012
- 2016
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Ingår i: BMJ Open Diabetes Research & Care. - : BMJ Publishing Group Ltd. - 2052-4897. ; 4:1
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Tidskriftsartikel (refereegranskat)abstract
- Objective: Diabetes in pregnancy has been shown to increase in parallel with the increasing prevalence of obesity. In this national population-based study, we analyzed the trends for gestational diabetes mellitus (GDM), type 1 diabetes in pregnancy, and type 2 diabetes in pregnancy in Sweden between 1998 and 2012.Research design and methods: A population-based cohort study using the Swedish national medical birth registry data. The time periods were categorized into 3-year intervals and adjusted for maternal body mass index (BMI), ethnicity, and age in a logistic regression.Results: Each type of diabetes increased over the studied 15-year period. Type 1 diabetes increased by 33.2% (22.2-45.3) and type 2 diabetes by 111% (62.2-174.4) in the adjusted model. Nordic women had the highest prevalence of type 1 diabetes (0.47%) compared with other ethnic groups. The increase in GDM and, to a lesser extent, type 2 diabetes was explained by country of birth, BMI, and maternal age. The prevalence of GDM in Nordic women (0.7-0.8%) did not increase significantly over the time period.Conclusions: All types of diabetes in pregnancy increased over the 15-year time period in Sweden. Maternal pre-pregnancy BMI remains the key factor explaining the increase in GDM/type 2 diabetes. How to turn around the growing prevalence of diabetes in pregnancy, with its short-term and long-term health effects on both mother and child, requires population-based interventions that reduce the likelihood of entering pregnancy with a raised BMI.
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