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

Fadl, Helena ; Saeedi, Maryam ; Montgomery, Scott ; Magnuson, Anders ; Schwarcz, Erik ; Berntorp, Kerstin LU ; Sengpiel, Verena ; Storck-Lindholm, Elisabeth ; Strevens, Helena LU and Wikström, Anna Karin , et al. (2019) In BMC Pregnancy and Childbirth 19(1).
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... (More)

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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publication status
published
subject
keywords
Diagnostic criteria, Gestational diabetes mellitus, Health economics, LGA, Obesity, Pregnancy outcomes, Stepped wedge cluster randomised controlled trial, WHO 2013 criteria
in
BMC Pregnancy and Childbirth
volume
19
issue
1
article number
398
publisher
BioMed Central
external identifiers
  • scopus:85074418210
  • pmid:31675922
ISSN
1471-2393
DOI
10.1186/s12884-019-2547-5
language
English
LU publication?
yes
id
cd68b3fc-0658-43d6-a364-5dc57a59ad1e
date added to LUP
2019-11-19 13:27:40
date last changed
2020-01-13 02:32:00
@article{cd68b3fc-0658-43d6-a364-5dc57a59ad1e,
  abstract     = {<p>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).</p>},
  author       = {Fadl, Helena and Saeedi, Maryam and Montgomery, Scott and Magnuson, Anders and Schwarcz, Erik and Berntorp, Kerstin and Sengpiel, Verena and Storck-Lindholm, Elisabeth and Strevens, Helena and Wikström, Anna Karin and Brismar-Wendel, Sophia and Persson, Martina and Jansson, Stefan and Ahlsson, Fredrik and Ursing, Carina and Ryen, Linda and Petersson, Kerstin and Wennerholm, Ulla Britt and Hildén, Karin and Simmons, David},
  issn         = {1471-2393},
  language     = {eng},
  number       = {1},
  publisher    = {BioMed Central},
  series       = {BMC Pregnancy and Childbirth},
  title        = {Changing diagnostic criteria for gestational diabetes in Sweden - A stepped wedge national cluster randomised controlled trial - The CDC4G study protocol},
  url          = {http://dx.doi.org/10.1186/s12884-019-2547-5},
  doi          = {10.1186/s12884-019-2547-5},
  volume       = {19},
  year         = {2019},
}