Changing diagnostic criteria for gestational diabetes in Sweden - a stepped wedge national cluster randomised controlled trial - the CDC4G study protocol
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 screenin...
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| Format: | Article |
| Language: | English |
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BMC
2019-11-01
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| Series: | BMC Pregnancy and Childbirth |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s12884-019-2547-5 |
| _version_ | 1818997399161405440 |
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| author | Helena Fadl Maryam Saeedi Scott Montgomery Anders Magnuson Erik Schwarcz Kerstin Berntorp Verena Sengpiel Elisabeth Storck-Lindholm Helena Strevens Anna-Karin Wikström Sophia Brismar-Wendel Martina Persson Stefan Jansson Fredrik Ahlsson Carina Ursing Linda Ryen Kerstin Petersson Ulla-Britt Wennerholm Karin Hildén David Simmons |
| author_facet | Helena Fadl Maryam Saeedi Scott Montgomery Anders Magnuson Erik Schwarcz Kerstin Berntorp Verena Sengpiel Elisabeth Storck-Lindholm Helena Strevens Anna-Karin Wikström Sophia Brismar-Wendel Martina Persson Stefan Jansson Fredrik Ahlsson Carina Ursing Linda Ryen Kerstin Petersson Ulla-Britt Wennerholm Karin Hildén David Simmons |
| author_sort | Helena Fadl |
| collection | DOAJ |
| description | 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) |
| first_indexed | 2024-12-20T21:45:01Z |
| format | Article |
| id | doaj.art-97b6a4ecddce48318569783d9ccec7fb |
| institution | Directory Open Access Journal |
| issn | 1471-2393 |
| language | English |
| last_indexed | 2024-12-20T21:45:01Z |
| publishDate | 2019-11-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Pregnancy and Childbirth |
| spelling | doaj.art-97b6a4ecddce48318569783d9ccec7fb2022-12-21T19:25:43ZengBMCBMC Pregnancy and Childbirth1471-23932019-11-0119111110.1186/s12884-019-2547-5Changing diagnostic criteria for gestational diabetes in Sweden - a stepped wedge national cluster randomised controlled trial - the CDC4G study protocolHelena Fadl0Maryam Saeedi1Scott Montgomery2Anders Magnuson3Erik Schwarcz4Kerstin Berntorp5Verena Sengpiel6Elisabeth Storck-Lindholm7Helena Strevens8Anna-Karin Wikström9Sophia Brismar-Wendel10Martina Persson11Stefan Jansson12Fredrik Ahlsson13Carina Ursing14Linda Ryen15Kerstin Petersson16Ulla-Britt Wennerholm17Karin Hildén18David Simmons19Department of Obstetrics and Gynaecology, Faculty of Medicine and Health, Örebro UniversityDepartment of Obstetrics and Gynaecology, Faculty of Medicine and Health, Örebro UniversityClinical Epidemiology and Biostatistics, School of Medical Sciences, Örebro UniversityClinical Epidemiology and Biostatistics, University Hospital ÖrebroDepartment of Internal Medicine, School of medical health and sciences, Örebro University HospitalDepartment of Endocrinology, Skåne University Hospital, Clinical Research Center Malmö, Lund UniversityDepartment of Obstetrics and Gynaecology, Sahlgrenska University Hospital, Sahlgrenska Academy, University of GothenburgDepartment of Obstetrics and GynaecologyDepartment of Obstetrics and Gynaecology, Skåne University Hospital, Clinical Research Center Lund, Lund UniversityWomen’s and Children’s Health, Uppsala universityDepartment of Clinical Sciences, Karolinska Institutet Danderyd HospitalDepartment of Paediatrics, Sachsska Children’s and Youth hospital and Department of Clinical Science and Education, Karolinska InstituteSchool of Medical Sciences, University Health Care Research Center, Örebro UniversityDepartment of Women’s and Children’s health, Uppsala UniversityDepartment of EndocrinologyCenter for Health Care Science, Faculty of Medicine and Health, Örebro UniversityDepartment of Clinical Sciences, Obstetrics and Gynaecology, Umeå UniversityDepartment of Obstetrics and Gynaecology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Sahlgrenska University HospitalDepartment of Obstetrics and Gynaecology, Faculty of Medicine and Health, Örebro UniversityMacarthur Clinical School, Western Sydney UniversityAbstract 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)http://link.springer.com/article/10.1186/s12884-019-2547-5Gestational diabetes mellitusPregnancy outcomesDiagnostic criteriaWHO 2013 criteriaStepped wedge cluster randomised controlled trialLGA |
| spellingShingle | Helena Fadl Maryam Saeedi Scott Montgomery Anders Magnuson Erik Schwarcz Kerstin Berntorp Verena Sengpiel Elisabeth Storck-Lindholm Helena Strevens Anna-Karin Wikström Sophia Brismar-Wendel Martina Persson Stefan Jansson Fredrik Ahlsson Carina Ursing Linda Ryen Kerstin Petersson Ulla-Britt Wennerholm Karin Hildén David Simmons Changing diagnostic criteria for gestational diabetes in Sweden - a stepped wedge national cluster randomised controlled trial - the CDC4G study protocol BMC Pregnancy and Childbirth Gestational diabetes mellitus Pregnancy outcomes Diagnostic criteria WHO 2013 criteria Stepped wedge cluster randomised controlled trial LGA |
| title | Changing diagnostic criteria for gestational diabetes in Sweden - a stepped wedge national cluster randomised controlled trial - the CDC4G study protocol |
| title_full | Changing diagnostic criteria for gestational diabetes in Sweden - a stepped wedge national cluster randomised controlled trial - the CDC4G study protocol |
| title_fullStr | Changing diagnostic criteria for gestational diabetes in Sweden - a stepped wedge national cluster randomised controlled trial - the CDC4G study protocol |
| title_full_unstemmed | Changing diagnostic criteria for gestational diabetes in Sweden - a stepped wedge national cluster randomised controlled trial - the CDC4G study protocol |
| title_short | Changing diagnostic criteria for gestational diabetes in Sweden - a stepped wedge national cluster randomised controlled trial - the CDC4G study protocol |
| title_sort | changing diagnostic criteria for gestational diabetes in sweden a stepped wedge national cluster randomised controlled trial the cdc4g study protocol |
| topic | Gestational diabetes mellitus Pregnancy outcomes Diagnostic criteria WHO 2013 criteria Stepped wedge cluster randomised controlled trial LGA |
| url | http://link.springer.com/article/10.1186/s12884-019-2547-5 |
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