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...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Helena Fadl [verfasserIn] Maryam Saeedi [verfasserIn] Scott Montgomery [verfasserIn] Anders Magnuson [verfasserIn] Erik Schwarcz [verfasserIn] Kerstin Berntorp [verfasserIn] Verena Sengpiel [verfasserIn] Elisabeth Storck-Lindholm [verfasserIn] Helena Strevens [verfasserIn] Anna-Karin Wikström [verfasserIn] Sophia Brismar-Wendel [verfasserIn] Martina Persson [verfasserIn] Stefan Jansson [verfasserIn] Fredrik Ahlsson [verfasserIn] Carina Ursing [verfasserIn] Linda Ryen [verfasserIn] Kerstin Petersson [verfasserIn] Ulla-Britt Wennerholm [verfasserIn] Karin Hildén [verfasserIn] David Simmons [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2019 |
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| Schlagwörter: |
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| Übergeordnetes Werk: |
In: BMC Pregnancy and Childbirth - BMC, 2003, 19(2019), 1, Seite 11 |
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| Übergeordnetes Werk: |
volume:19 ; year:2019 ; number:1 ; pages:11 |
| Links: |
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| DOI / URN: |
10.1186/s12884-019-2547-5 |
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| Katalog-ID: |
DOAJ075569116 |
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| 520 | |a 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) | ||
| 650 | 4 | |a Gestational diabetes mellitus | |
| 650 | 4 | |a Pregnancy outcomes | |
| 650 | 4 | |a Diagnostic criteria | |
| 650 | 4 | |a WHO 2013 criteria | |
| 650 | 4 | |a Stepped wedge cluster randomised controlled trial | |
| 650 | 4 | |a LGA | |
| 653 | 0 | |a Gynecology and obstetrics | |
| 700 | 0 | |a Maryam Saeedi |e verfasserin |4 aut | |
| 700 | 0 | |a Scott Montgomery |e verfasserin |4 aut | |
| 700 | 0 | |a Anders Magnuson |e verfasserin |4 aut | |
| 700 | 0 | |a Erik Schwarcz |e verfasserin |4 aut | |
| 700 | 0 | |a Kerstin Berntorp |e verfasserin |4 aut | |
| 700 | 0 | |a Verena Sengpiel |e verfasserin |4 aut | |
| 700 | 0 | |a Elisabeth Storck-Lindholm |e verfasserin |4 aut | |
| 700 | 0 | |a Helena Strevens |e verfasserin |4 aut | |
| 700 | 0 | |a Anna-Karin Wikström |e verfasserin |4 aut | |
| 700 | 0 | |a Sophia Brismar-Wendel |e verfasserin |4 aut | |
| 700 | 0 | |a Martina Persson |e verfasserin |4 aut | |
| 700 | 0 | |a Stefan Jansson |e verfasserin |4 aut | |
| 700 | 0 | |a Fredrik Ahlsson |e verfasserin |4 aut | |
| 700 | 0 | |a Carina Ursing |e verfasserin |4 aut | |
| 700 | 0 | |a Linda Ryen |e verfasserin |4 aut | |
| 700 | 0 | |a Kerstin Petersson |e verfasserin |4 aut | |
| 700 | 0 | |a Ulla-Britt Wennerholm |e verfasserin |4 aut | |
| 700 | 0 | |a Karin Hildén |e verfasserin |4 aut | |
| 700 | 0 | |a David Simmons |e verfasserin |4 aut | |
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10.1186/s12884-019-2547-5 doi (DE-627)DOAJ075569116 (DE-599)DOAJ97b6a4ecddce48318569783d9ccec7fb DE-627 ger DE-627 rakwb eng RG1-991 Helena Fadl verfasserin aut Changing diagnostic criteria for gestational diabetes in Sweden - a stepped wedge national cluster randomised controlled trial - the CDC4G study protocol 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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) Gestational diabetes mellitus Pregnancy outcomes Diagnostic criteria WHO 2013 criteria Stepped wedge cluster randomised controlled trial LGA Gynecology and obstetrics Maryam Saeedi verfasserin aut Scott Montgomery verfasserin aut Anders Magnuson verfasserin aut Erik Schwarcz verfasserin aut Kerstin Berntorp verfasserin aut Verena Sengpiel verfasserin aut Elisabeth Storck-Lindholm verfasserin aut Helena Strevens verfasserin aut Anna-Karin Wikström verfasserin aut Sophia Brismar-Wendel verfasserin aut Martina Persson verfasserin aut Stefan Jansson verfasserin aut Fredrik Ahlsson verfasserin aut Carina Ursing verfasserin aut Linda Ryen verfasserin aut Kerstin Petersson verfasserin aut Ulla-Britt Wennerholm verfasserin aut Karin Hildén verfasserin aut David Simmons verfasserin aut In BMC Pregnancy and Childbirth BMC, 2003 19(2019), 1, Seite 11 (DE-627)335489087 (DE-600)2059869-5 14712393 nnns volume:19 year:2019 number:1 pages:11 https://doi.org/10.1186/s12884-019-2547-5 kostenfrei https://doaj.org/article/97b6a4ecddce48318569783d9ccec7fb kostenfrei http://link.springer.com/article/10.1186/s12884-019-2547-5 kostenfrei https://doaj.org/toc/1471-2393 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 19 2019 1 11 |
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10.1186/s12884-019-2547-5 doi (DE-627)DOAJ075569116 (DE-599)DOAJ97b6a4ecddce48318569783d9ccec7fb DE-627 ger DE-627 rakwb eng RG1-991 Helena Fadl verfasserin aut Changing diagnostic criteria for gestational diabetes in Sweden - a stepped wedge national cluster randomised controlled trial - the CDC4G study protocol 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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) Gestational diabetes mellitus Pregnancy outcomes Diagnostic criteria WHO 2013 criteria Stepped wedge cluster randomised controlled trial LGA Gynecology and obstetrics Maryam Saeedi verfasserin aut Scott Montgomery verfasserin aut Anders Magnuson verfasserin aut Erik Schwarcz verfasserin aut Kerstin Berntorp verfasserin aut Verena Sengpiel verfasserin aut Elisabeth Storck-Lindholm verfasserin aut Helena Strevens verfasserin aut Anna-Karin Wikström verfasserin aut Sophia Brismar-Wendel verfasserin aut Martina Persson verfasserin aut Stefan Jansson verfasserin aut Fredrik Ahlsson verfasserin aut Carina Ursing verfasserin aut Linda Ryen verfasserin aut Kerstin Petersson verfasserin aut Ulla-Britt Wennerholm verfasserin aut Karin Hildén verfasserin aut David Simmons verfasserin aut In BMC Pregnancy and Childbirth BMC, 2003 19(2019), 1, Seite 11 (DE-627)335489087 (DE-600)2059869-5 14712393 nnns volume:19 year:2019 number:1 pages:11 https://doi.org/10.1186/s12884-019-2547-5 kostenfrei https://doaj.org/article/97b6a4ecddce48318569783d9ccec7fb kostenfrei http://link.springer.com/article/10.1186/s12884-019-2547-5 kostenfrei https://doaj.org/toc/1471-2393 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 19 2019 1 11 |
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10.1186/s12884-019-2547-5 doi (DE-627)DOAJ075569116 (DE-599)DOAJ97b6a4ecddce48318569783d9ccec7fb DE-627 ger DE-627 rakwb eng RG1-991 Helena Fadl verfasserin aut Changing diagnostic criteria for gestational diabetes in Sweden - a stepped wedge national cluster randomised controlled trial - the CDC4G study protocol 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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) Gestational diabetes mellitus Pregnancy outcomes Diagnostic criteria WHO 2013 criteria Stepped wedge cluster randomised controlled trial LGA Gynecology and obstetrics Maryam Saeedi verfasserin aut Scott Montgomery verfasserin aut Anders Magnuson verfasserin aut Erik Schwarcz verfasserin aut Kerstin Berntorp verfasserin aut Verena Sengpiel verfasserin aut Elisabeth Storck-Lindholm verfasserin aut Helena Strevens verfasserin aut Anna-Karin Wikström verfasserin aut Sophia Brismar-Wendel verfasserin aut Martina Persson verfasserin aut Stefan Jansson verfasserin aut Fredrik Ahlsson verfasserin aut Carina Ursing verfasserin aut Linda Ryen verfasserin aut Kerstin Petersson verfasserin aut Ulla-Britt Wennerholm verfasserin aut Karin Hildén verfasserin aut David Simmons verfasserin aut In BMC Pregnancy and Childbirth BMC, 2003 19(2019), 1, Seite 11 (DE-627)335489087 (DE-600)2059869-5 14712393 nnns volume:19 year:2019 number:1 pages:11 https://doi.org/10.1186/s12884-019-2547-5 kostenfrei https://doaj.org/article/97b6a4ecddce48318569783d9ccec7fb kostenfrei http://link.springer.com/article/10.1186/s12884-019-2547-5 kostenfrei https://doaj.org/toc/1471-2393 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 19 2019 1 11 |
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10.1186/s12884-019-2547-5 doi (DE-627)DOAJ075569116 (DE-599)DOAJ97b6a4ecddce48318569783d9ccec7fb DE-627 ger DE-627 rakwb eng RG1-991 Helena Fadl verfasserin aut Changing diagnostic criteria for gestational diabetes in Sweden - a stepped wedge national cluster randomised controlled trial - the CDC4G study protocol 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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) Gestational diabetes mellitus Pregnancy outcomes Diagnostic criteria WHO 2013 criteria Stepped wedge cluster randomised controlled trial LGA Gynecology and obstetrics Maryam Saeedi verfasserin aut Scott Montgomery verfasserin aut Anders Magnuson verfasserin aut Erik Schwarcz verfasserin aut Kerstin Berntorp verfasserin aut Verena Sengpiel verfasserin aut Elisabeth Storck-Lindholm verfasserin aut Helena Strevens verfasserin aut Anna-Karin Wikström verfasserin aut Sophia Brismar-Wendel verfasserin aut Martina Persson verfasserin aut Stefan Jansson verfasserin aut Fredrik Ahlsson verfasserin aut Carina Ursing verfasserin aut Linda Ryen verfasserin aut Kerstin Petersson verfasserin aut Ulla-Britt Wennerholm verfasserin aut Karin Hildén verfasserin aut David Simmons verfasserin aut In BMC Pregnancy and Childbirth BMC, 2003 19(2019), 1, Seite 11 (DE-627)335489087 (DE-600)2059869-5 14712393 nnns volume:19 year:2019 number:1 pages:11 https://doi.org/10.1186/s12884-019-2547-5 kostenfrei https://doaj.org/article/97b6a4ecddce48318569783d9ccec7fb kostenfrei http://link.springer.com/article/10.1186/s12884-019-2547-5 kostenfrei https://doaj.org/toc/1471-2393 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 19 2019 1 11 |
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10.1186/s12884-019-2547-5 doi (DE-627)DOAJ075569116 (DE-599)DOAJ97b6a4ecddce48318569783d9ccec7fb DE-627 ger DE-627 rakwb eng RG1-991 Helena Fadl verfasserin aut Changing diagnostic criteria for gestational diabetes in Sweden - a stepped wedge national cluster randomised controlled trial - the CDC4G study protocol 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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) Gestational diabetes mellitus Pregnancy outcomes Diagnostic criteria WHO 2013 criteria Stepped wedge cluster randomised controlled trial LGA Gynecology and obstetrics Maryam Saeedi verfasserin aut Scott Montgomery verfasserin aut Anders Magnuson verfasserin aut Erik Schwarcz verfasserin aut Kerstin Berntorp verfasserin aut Verena Sengpiel verfasserin aut Elisabeth Storck-Lindholm verfasserin aut Helena Strevens verfasserin aut Anna-Karin Wikström verfasserin aut Sophia Brismar-Wendel verfasserin aut Martina Persson verfasserin aut Stefan Jansson verfasserin aut Fredrik Ahlsson verfasserin aut Carina Ursing verfasserin aut Linda Ryen verfasserin aut Kerstin Petersson verfasserin aut Ulla-Britt Wennerholm verfasserin aut Karin Hildén verfasserin aut David Simmons verfasserin aut In BMC Pregnancy and Childbirth BMC, 2003 19(2019), 1, Seite 11 (DE-627)335489087 (DE-600)2059869-5 14712393 nnns volume:19 year:2019 number:1 pages:11 https://doi.org/10.1186/s12884-019-2547-5 kostenfrei https://doaj.org/article/97b6a4ecddce48318569783d9ccec7fb kostenfrei http://link.springer.com/article/10.1186/s12884-019-2547-5 kostenfrei https://doaj.org/toc/1471-2393 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 19 2019 1 11 |
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Helena Fadl @@aut@@ Maryam Saeedi @@aut@@ Scott Montgomery @@aut@@ Anders Magnuson @@aut@@ Erik Schwarcz @@aut@@ Kerstin Berntorp @@aut@@ Verena Sengpiel @@aut@@ Elisabeth Storck-Lindholm @@aut@@ Helena Strevens @@aut@@ Anna-Karin Wikström @@aut@@ Sophia Brismar-Wendel @@aut@@ Martina Persson @@aut@@ Stefan Jansson @@aut@@ Fredrik Ahlsson @@aut@@ Carina Ursing @@aut@@ Linda Ryen @@aut@@ Kerstin Petersson @@aut@@ Ulla-Britt Wennerholm @@aut@@ Karin Hildén @@aut@@ David Simmons @@aut@@ |
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Changing diagnostic criteria for gestational diabetes in Sweden - a stepped wedge national cluster randomised controlled trial - the CDC4G study protocol |
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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) |
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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) |
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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) |
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