CoChat
Sign Up
Cited by 34Gestational Diabetes Research and ManagementMaternal and Neonatal HealthcarePregnancy and Medication Impact

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

Open access
Fadl, Helena, Saeedi, Maryam, Montgomery, Scott, Magnuson, Anders, Schwarcz, Erik, Berntorp, Kerstin, Sengpiel, Verena, Storck-Lindholm, Elisabeth +12 more·2019·BMC Pregnancy and Childbirth
DOI 10.1186/s12884-019-2547-5PMC PMC6823965
Open this paper in CoChat — free accountOpen PDF

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 (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)

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Integrity signals

Registry

Crossref · 10.1186/s12884-019-2547-5

Cites

10 of 10 references verified0 citation errors · 0 not checkable

Statistics

Claims the paper makes

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

The self-check needs the paper’s full text.

Cites

Flagged first, then by citations

Research works printed but not linked: 31

  1. [1]WHO. Diagnostic criteria and Classification of Hyperglycaemia First Detected in pregnancy 2013. Available from: http://www.who.int/diabetes/publications/Hyperglycaemia_In_Pregnancy/en/index.html. Access 6 May 2019. 24199271
  2. [5]Fadl HE Simmons D Trends in diabetes in pregnancy in Sweden 1998-2012 BMJ Open Diabetes Res Care 2016 4 1 e000221 PMC4985983 27547412
  3. [6]Metzger BE Lowe LP Dyer AR Trimble ER Chaovarindr U Coustan DR Hyperglycemia and adverse pregnancy outcomes N Engl J Med 2008 358 19 1991 2002 18463375
  4. [8]Bellamy L Casas JP Hingorani AD Williams D Type 2 diabetes mellitus after gestational diabetes: a systematic review and meta-analysis Lancet. 2009 373 9677 1773 1779 19465232
  5. [9]Anderberg E Landin-Olsson M Kalen J Frid A Ursing D Berntorp K Prevalence of impaired glucose tolerance and diabetes after gestational diabetes mellitus comparing different cut-off criteria for abnormal glucose tolerance during pregnancy Acta Obstet Gynecol Scand 2011 90 11 1252 1258 21679163
  6. [10]Brown FM Isganaitis E James-Todd T Much to HAPO FUS about: increasing maternal Glycemia in pregnancy is associated with worsening childhood glucose metabolism Diabetes Care 2019 42 3 393 395 30787060 PMC6905477
  7. [11]Longmore DK Barr ELM Lee IL Barzi F Kirkwood M Whitbread C Maternal body mass index, excess gestational weight gain, and diabetes are positively associated with neonatal adiposity in the pregnancy and neonatal diabetes outcomes in remote Australia (PANDORA) study Pediatr Obes 2019 14 4 e12490 30650263
  8. [12]Fadl HE Gardefors S Hjertberg R Nord E Persson B Schwarcz E Randomized controlled study in pregnancy on treatment of marked hyperglycemia that is short of overt diabetes Acta Obstet Gynecol Scand 2015 94 11 1181 1187 26222270
  9. [15]Feig DS Hwee J Shah BR Booth GL Bierman AS Lipscombe LL Trends in incidence of diabetes in pregnancy and serious perinatal outcomes: a large, population-based study in Ontario, Canada, 1996-2010 Diabetes Care 2014 37 6 1590 1596 24705609
  10. [16]Helseth R Salvesen O Stafne SN Morkved S Salvesen KA Carlsen SM Gestational diabetes mellitus among Nordic Caucasian women: prevalence and risk factors according to WHO and simplified IADPSG criteria Scand J Clin Lab Invest 2014 74 7 620 628 24980704
  11. [17]Ignell C Claesson R Anderberg E Berntorp K Trends in the prevalence of gestational diabetes mellitus in southern Sweden, 2003-2012 Acta Obstet Gynecol Scand 2014 93 4 420 424 24450766
  12. [18]Metzger BE Gabbe SG Persson B Buchanan TA Catalano PA Damm P International association of diabetes and pregnancy study groups recommendations on the diagnosis and classification of hyperglycemia in pregnancy Diabetes Care 2010 33 3 676 682 20190296 PMC2827530
  13. [19]Weile LK Kahn JG Marseille E Jensen DM Damm P Lohse N Global cost-effectiveness of GDM screening and management: current knowledge and future needs Best Pract Res Clin Obstet Gynaecol 2015 29 2 206 224 25225056
  14. [20]Chen PY Finkelstein EA Ng MJ Yap F Yeo GS Rajadurai VS Incremental cost-effectiveness analysis of gestational diabetes mellitus screening strategies in Singapore Asia Pac J Public Health 2016 28 1 15 25 26512030
  15. [21]Mission JF Ohno MS Cheng YW Caughey AB Gestational diabetes screening with the new IADPSG guidelines: a cost-effectiveness analysis Am J Obstet Gynecol 2012 207 4 326 22840972 PMC4621259
  16. [22]Gillespie P O'Neill C Avalos G Dunne FP Collaborators AD New estimates of the costs of universal screening for gestational diabetes mellitus in Ireland Ir Med J 2012 105 5 Suppl 15 18 22838102
  17. [23]Canadian Diabetes Association Clinical Practice Guidelines Expert C Booth G Cheng AY Canadian Diabetes Association 2013 clinical practice guidelines for the prevention and management of diabetes in Canada. Methods Can J Diabetes 2013 37 Suppl 1 S4 S7 24070961
  18. [24]Canadian Diabetes Association Clinical Practice Guidelines Expert C Cheng AY Canadian Diabetes Association 2013 clinical practice guidelines for the prevention and management of diabetes in Canada. Introduction Can J Diabetes 2013 37 Suppl 1 S1 S3 24070926
  19. [25]Lindqvist M Persson M Lindkvist M Mogren I No consensus on gestational diabetes mellitus screening regimes in Sweden: pregnancy outcomes in relation to different screening regimes 2011 to 2012, a cross-sectional study BMC Pregnancy Childbirth 2014 14 185 24884711 PMC4055242
  20. [27]de Hoop E van der Tweel I van der Graaf R Moons KG van Delden JJ Reitsma JB The need to balance merits and limitations from different disciplines when considering the stepped wedge cluster randomized trial design BMC Med Res Methodol 2015 15 93 26514920 PMC4627408
  21. [28]Ferrara A Hedderson MM Albright CL Brown SD Ehrlich SF Caan BJ A pragmatic cluster randomized clinical trial of diabetes prevention strategies for women with gestational diabetes: design and rationale of the gestational Diabetes’ effects on moms (GEM) study BMC Pregnancy Childbirth 2014 14 21 24423410 PMC3897959
  22. [30]Hemming K Lilford R Girling AJ Stepped-wedge cluster randomised controlled trials: a generic framework including parallel and multiple-level designs Stat Med 2015 34 2 181 196 25346484 PMC4286109
  23. [31]Maršál K Persson PH Larsen T Lilja H Selbing A Sultan B Intrauterine growth curves based on ultrasonically estimated foetal weights Acta Paediatr 1996 85 7 843 848 8819552
  24. [32]Poolsup N Suksomboon N Amin M Effect of treatment of gestational diabetes mellitus: a systematic review and meta-analysis PLoS One 2014 9 3 e92485 24658089 PMC3962411
  25. [33]Stephansson O, Petersson K, Bjork C, Conner P, Wikstrom AK. The Swedish pregnancy register - for quality of care improvement and research. Acta Obstet Gynecol Scand. 2017. PMC5873375 29172245
  26. [34]Hemming K Taljaard M Sample size calculations for stepped wedge and cluster randomised trials: a unified approach J Clin Epidemiol 2016 69 137 146 26344808 PMC4687983
  27. [35]Hemming K Taljaard M Forbes A Modeling clustering and treatment effect heterogeneity in parallel and stepped-wedge cluster randomized trials Stat Med 2018 37 6 883 898 29315688 PMC5817269
  28. [36]Edlund M Burstrom L Gerhardsson L Lundstrom R Nilsson T Sanden H A prospective cohort study investigating an exposure-response relationship among vibration-exposed male workers with numbness of the hands Scand J Work Environ Health 2014 40 2 203 209 24067946
  29. [37]Hung TH Hsieh TT The effects of implementing the International Association of Diabetes and Pregnancy Study Groups criteria for diagnosing gestational diabetes on maternal and neonatal outcomes PLoS One 2015 10 3 e0122261 25756838 PMC4355616
  30. [38]Wu ET Nien FJ Kuo CH Chen SC Chen KY Chuang LM Diagnosis of more gestational diabetes lead to better pregnancy outcomes: comparing the International Association of the Diabetes and Pregnancy Study Group criteria, and the Carpenter and Coustan criteria J Diabetes Investig 2016 7 1 121 126 PMC4718104 26816609
  31. [39]Duran A Saenz S Torrejon MJ Bordiu E Del Valle L Galindo M Introduction of IADPSG criteria for the screening and diagnosis of gestational diabetes mellitus results in improved pregnancy outcomes at a lower cost in a large cohort of pregnant women: the St. Carlos Gestational Diabetes Study Diabetes Care 2014 37 9 2442 2450 24947793

Cited by

Sorted by citations

Authors
Fadl, H., Saeedi, M., Montgomery, S., Magnuson, A., Schwarcz, E., Berntorp, K., Sengpiel, V., Storck-Lindholm, E., Strevens, H., Wikström, A.-K., Brismar-Wendel, S., Persson, M., Jansson, S., Ahlsson, F., Ursing, C., Ryen, L., Petersson, K., Wennerholm, U.-B., Hildén, K., & Simmons, D.
Affiliations
  • Örebro University (SE)
  • Örebro University Hospital (SE)
  • Lund University (SE)
  • Sahlgrenska University Hospital (SE)
  • Uppsala University (SE)
  • Karolinska Institutet (SE)
  • Stockholm South General Hospital (SE)
  • Umeå University (SE)
Corresponding author
Fadl, Helena
ORCID
Venue
BMC Pregnancy and Childbirth
Publisher
Springer Science and Business Media LLC
Published
2019-11-01
Volume
19
Issue
1
Pages
398-398
ISSN
1471-2393 (ISSN-L)
DOI
10.1186/s12884-019-2547-5
PMC
PMC6823965
OpenAlex
W2984995723
Cited by
34
References
10
Citations by year
2026: 3 · 2025: 6 · 2024: 5 · 2023: 8 · 2022: 5 · 2021: 3 · 2020: 4
FWCI
3.26
Type
journal article
Language
en
Open access
Licence
Locations
  • BMC Pregnancy and Childbirth (publishedVersion, cc-by)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • DiVA at Umeå University (Umeå University) (submittedVersion, other-oa)
  • KTH Publication Database DiVA (KTH Royal Institute of Technology) (submittedVersion, other-oa)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
  • Lund University Publications (Lund University) (submittedVersion)
Funders
  • Vetenskapsrådet (2018-00470)
  • Fru Mary von Sydows (107)
  • Fru Mary von Sydow (4917, 2618)
  • ALFGBG (823211)
  • Nyckelfonden (OLL-597601)
  • Region Örebro län (OLL-693551, OLL-786911)
  • Regional Research Committee Uppsala-Örebro (RFR-749241)
Topics
  • Health Sciences › Medicine › Obstetrics and Gynecology › Gestational Diabetes Research and Management
  • Health Sciences › Health Professions › General Health Professions › Maternal and Neonatal Healthcare
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Pregnancy and Medication Impact
Keywords
gestational diabetes mellitus, diagnostic criteria, GDM screening, hyperglycemia in pregnancy, pregnancy outcomes, maternal outcomes, neonatal outcomes, health economic impact
MeSH terms
Adult, Female, Humans, Pregnancy, Pregnancy Outcome, Prenatal Diagnosis, Prospective Studies, Sweden, Cluster Analysis, Randomized Controlled Trials as Topic, Diabetes, Gestational, Practice Guidelines as Topic

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review