TY - JOUR
T1 - Changing diagnostic criteria for gestational diabetes in Sweden : a stepped wedge national cluster randomised controlled trial : the CDC4G study protocol
AU - Fadl, Helena
AU - Saeedi, Maryam
AU - Montgomery, Scott
AU - Magnuson, Anders
AU - Schwarcz, Erik
AU - Berntorp, Kerstin
AU - Sengpiel, Verena
AU - Storck-Lindholm, Elisabeth
AU - Strevens, Helena
AU - Wikström, Anna-Karin
AU - Brismar-Wendel, Sophia
AU - Persson, Martina
AU - Jansson, Stefan
AU - Ahlsson, Fredrik
AU - Ursing, Carina
AU - Ryen, Linda
AU - Petersson, Kerstin
AU - Wennerholm, Ulla-Britt
AU - Hildén, Karin
AU - Simmons, David
PY - 2019
Y1 - 2019
N2 - 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).
AB - 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).
KW - Sweden
KW - diabetes in pregnancy
KW - obesity
KW - pregnancy
UR - https://hdl.handle.net/1959.7/uws:54797
U2 - 10.1186/s12884-019-2547-5
DO - 10.1186/s12884-019-2547-5
M3 - Article
SN - 1471-2393
VL - 19
JO - BMC Pregnancy and Childbirth
JF - BMC Pregnancy and Childbirth
IS - 1
M1 - 398
ER -