Gestational Diabetes Mellitus (GDM) is diabetes that is detected during pregnancy - not Type 1 or Type 2 diabetes. GDM is currently being managed differently in different hospitals / regions and the healthcare is not equal. in 2015 the Swedish National Board of Health and Welfare´s made new recommendations for GDM diagnosis criteria, consistent with WHO's recommendations from 2013. The new lower limit values are based on the risk of obstetric outcomes, but there is no evidence of impact of the change in diagnostic criteria in Sweden. The new criteria represent a major change in the number of pregnant who are diagnosed (estimated at least threefold increase in frequency based on studies in other countries depending on screening model), but we know that treatment of high blood sugar values reduces the proportion of children large fro gestation age and childbirth complications. The expected outcome is thus, a significant reduction in the proportion of large children and complications related to this during childbirth. Follow-up of both mothers and children and their long-term health will be performed through the national health and quality records.
The CDC4G study is a stepped-wedge randomized national multicenter study, where participating clinics (11 clinics) have all introduced common guidelines for managing GDM, and where clinics in 2018 are randomized to changing diagnostic criteria monthly. During the autumn of 2017 and within the framework of the project, all participating women's clinics and maternity care units will introduce and quality assure their treatment routines during pregnancy. From January 2018, data collection starts and the first clinic is randomized February 2018. The study will last 1 year and data will be collected via the Pregnancy Register (www.graviditetsregistret.se). The study is supported by SNAKS (www.sfog.se). An estimated 65-70,000 pregnant women will be included in the study during 2018. Women included during 2018 have had their delivery during 2019 and during 2020 we are now working with data management.
The results of the study are expected to be of great importance both nationally and internationally. For the operations that deal with pregnant women with diabetes, and for the individual future pregnant woman, the study results will hopefully contribute to a more equal care of GDM, no matter where in Sweden you live.
The CDC4G study is listed on the ISRCTN registry with study ID ISRCTN41918550 (15/12/2017).
Principal Investigator, Research leader is Helena Fadl
MD, PhD, consultant, reserach manager
Kvinnokliniken Region Örebro Län