Randomized controlled study in pregnancy on treatment of marked hyperglycemia that is short of overt diabetes

Fadl, Helena; Gärdefors, Susanne; Hjertberg, Ragnhild; Nord, Eva; Persson, Bengt; Schwarcz, Erik; Åman, Jan; Östlund, Ingrid; Hanson, Ulf

doi:10.1111/aogs.12717

Cited by 22 publications

(22 citation statements)

References 12 publications

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“…To reduce rates of negative maternal outcomes and excessive fetal growth as effects of hyperglycaemia in the gestational diabetes group, different treatment strategies need to be evaluated. A recent study regarding treatment of severe hyperglycaemia with a more aggressive treatment, aiming for normoglycaemia, showed a significant reduction on fetal macrosomia . In that study, 67% of women required insulin treatment compared with 36% in the present study.…”

Section: Discussioncontrasting

confidence: 50%

Overweight and obesity: a remaining problem in women treated for severe gestational diabetes

Hildén¹,

Hanson

Persson

et al. 2016

Diabet. Med.

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AimTo analyse the impact of overweight and obesity on the risk of adverse maternal outcomes and fetal macrosomia in pregnancies of women treated for severe gestational diabetes.MethodsThis was a population‐based cohort study including all singleton pregnancies in Sweden without pre‐existing diabetes in the period 1998–2012. Only mothers with an early‐ pregnancy BMI of ≥ 18.5 kg/m² were included. Logistic regression analysis was used to determine odds ratios with 95% CIs for maternal outcomes and fetal growth. Analyses were stratified by maternal gestational diabetes/non‐gestational diabetes to investigate the impact of overweight/obesity in each group.ResultsOf 1 249 908 singleton births, 13 057 were diagnosed with gestational diabetes (1.0%). Overweight/obesity had the same impact on the risks of caesarean section and fetal macrosomia in pregnancies with and without gestational diabetes, but the impact of maternal BMI on the risk of preeclampsia was less pronounced in women with gestational diabetes. Normal‐weight women with gestational diabetes had an increased risk of caesarean section [odds ratio 1.26 (95% CI 1.16–1.37)], preeclampsia [odds ratio 2.03 (95% CI 1.71–2.41)] and large‐for‐gestational‐age infants [odds ratio 2.25 (95% CI 2.06–2.46)]. Risks were similar in the overweight group without gestational diabetes, caesarean section [odds ratio 1.34 (1.33–1.36)], preeclampsia odds ratio [1.76 (95% CI 1.72–1.81)], large‐for‐gestational‐age [odds ratio 1.76 (95% CI 1.74–1.79)].ConclusionsMaternal overweight and obesity is associated with similar increments in risks of adverse maternal outcomes and delivery of large‐for‐gestational‐age infants in women with and without gestational diabetes. Obese women with gestational diabetes are defined as a high‐risk group. Normal‐weight women with gestational diabetes have similar risks of adverse outcomes to overweight women without gestational diabetes.

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Section: Discussioncontrasting

confidence: 50%

Overweight and obesity: a remaining problem in women treated for severe gestational diabetes

Hildén¹,

Hanson

Persson

et al. 2016

Diabet. Med.

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“…Of 383 citations identified from electronic and hand-searches, we included four unique randomized trials (plus eight companion publications), representing a total of 767 children between 4 and 10 years old (Table 6.1, Figure 6.1). All were randomized controlled trials published in peer-reviewed journals between 1997 and 2015 and conducted in developed countries: Australia 258 , Canada 263 , Sweden 264 , and United States of America. 240 Two trials 258,264 enrolled women with at least one risk factor for GDM, while the other two 240,263 did not select their participants based on GDM risk factors.…”

Section: Resultsmentioning

confidence: 99%

Intensive gestational glycemic management and childhood obesity: a systematic review and meta-analysis

et al. 2017

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“…A non-randomised retrospective study in the USA found no benefit in outcomes [40] but substantial changes in clinical and obstetric care occurred at the same time [41]. The few randomised trials of treating GDM [12][13][14] have all studied different settings and diagnostic criteria, and a randomised study of the effect on outcomes by treatment on a population level does not exist. Sweden has a public health care system with almost 100% clinical attendance and public health registries with high coverage.…”

Section: Discussionmentioning

confidence: 99%

“…Treatment of GDM involves dietary and physical activity advice, blood glucose monitoring, and where necessary metformin or/ and insulin therapy. GDM management has been shown to reduce maternal and perinatal morbidity [12][13][14].…”

Section: Introductionmentioning

confidence: 99%

Changing diagnostic criteria for gestational diabetes in Sweden - a stepped wedge national cluster randomised controlled trial - the CDC4G study protocol

Fadl

Saeedi

Montgomery

et al. 2019

BMC Pregnancy Childbirth

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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 (www.cdc4g.se/en) 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. Trial registration: CDC4G is listed on the ISRCTN registry with study ID ISRCTN41918550 (15/12/2017

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Randomized controlled study in pregnancy on treatment of marked hyperglycemia that is short of overt diabetes

Abstract: Aiming for normalized glycemia in a pregnancy complicated by severe hyperglycemia reduces fetal growth but is associated with an increased rate of mild hypoglycemia.

Cited by 22 publications

References 12 publications

Overweight and obesity: a remaining problem in women treated for severe gestational diabetes

Overweight and obesity: a remaining problem in women treated for severe gestational diabetes

Intensive gestational glycemic management and childhood obesity: a systematic review and meta-analysis

Changing diagnostic criteria for gestational diabetes in Sweden - a stepped wedge national cluster randomised controlled trial - the CDC4G study protocol

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