TY - JOUR
T1 - Danish Diabetes Birth Registry 2: a study protocol of a national prospective cohort study to monitor outcomes of pregnancies of women with pre-existing diabetes
AU - Knorr, Sine
AU - Aalders, Jori
AU - Overgaard, Martin
AU - Støvring, Henrik
AU - Mathiesen, Elisabeth R
AU - Damm, Peter
AU - Clausen, Tine D
AU - Bjerre-Christensen, Ulla
AU - Andersen, Lise Lotte T
AU - Vinter, Christina
AU - Kofoed-Enevoldsen, Allan
AU - Lauenborg, Jeannet
AU - Kampmann, Ulla
AU - Fuglsang, Jens
AU - Ovesen, Per G
AU - Christensen, Trine T
AU - Sørensen, Anne
AU - Ringholm, Lene
AU - Jensen, Dorte M
N1 - © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2024/4/25
Y1 - 2024/4/25
N2 - Introduction Despite technological developments and intensified care, pregnancies in women with pre-existing diabetes are still considered high-risk pregnancies. The rate of adverse outcomes in pregnancies affected by diabetes in Denmark is currently unknown, and there is a limited understanding of mechanisms contributing to this elevated risk. To address these gaps, the Danish Diabetes Birth Registry 2 (DDBR2) was established. The aims of this registry are to evaluate maternal and fetal-neonatal outcomes based on 5 years cohort data, and to identify pathophysiology and risk factors associated with short-term and long-term outcomes of pregnancies in women with pre-existing diabetes. Methods and analysis The DDBR2 registry is a nationwide 5-year prospective cohort with an inclusion period from February 2023 to February 2028 of pregnancies in women with all types of pre-existing diabetes and includes registry, clinical and questionnaire data and biological samples of mother–partner–child trios. Eligible families (parents age ≥18 years and sufficient proficiency in Danish or English) can participate by either (1) basic level data obtained from medical records (mother and child) and questionnaires (partner) or (2) basic level data and additional data which includes questionnaires (mother and partner) and blood samples (all). The primary maternal outcome is Hemoglobin A1c (HbA1c) levels at the end of pregnancy and the primary offspring endpoint is the birth weight SD score. The DDBR2 registry will be complemented by genetic, epigenetic and metabolomic data as well as a biobank for future research, and the cohort will be followed through data from national databases to illuminate possible mechanisms that link maternal diabetes and other parental factors to a possible increased risk of adverse long-term child outcomes. Ethics and dissemination Approval from the Ethical Committee is obtained (S-20220039). Findings will be sought published in international scientific journals and shared among the participating hospitals and policymakers.
AB - Introduction Despite technological developments and intensified care, pregnancies in women with pre-existing diabetes are still considered high-risk pregnancies. The rate of adverse outcomes in pregnancies affected by diabetes in Denmark is currently unknown, and there is a limited understanding of mechanisms contributing to this elevated risk. To address these gaps, the Danish Diabetes Birth Registry 2 (DDBR2) was established. The aims of this registry are to evaluate maternal and fetal-neonatal outcomes based on 5 years cohort data, and to identify pathophysiology and risk factors associated with short-term and long-term outcomes of pregnancies in women with pre-existing diabetes. Methods and analysis The DDBR2 registry is a nationwide 5-year prospective cohort with an inclusion period from February 2023 to February 2028 of pregnancies in women with all types of pre-existing diabetes and includes registry, clinical and questionnaire data and biological samples of mother–partner–child trios. Eligible families (parents age ≥18 years and sufficient proficiency in Danish or English) can participate by either (1) basic level data obtained from medical records (mother and child) and questionnaires (partner) or (2) basic level data and additional data which includes questionnaires (mother and partner) and blood samples (all). The primary maternal outcome is Hemoglobin A1c (HbA1c) levels at the end of pregnancy and the primary offspring endpoint is the birth weight SD score. The DDBR2 registry will be complemented by genetic, epigenetic and metabolomic data as well as a biobank for future research, and the cohort will be followed through data from national databases to illuminate possible mechanisms that link maternal diabetes and other parental factors to a possible increased risk of adverse long-term child outcomes. Ethics and dissemination Approval from the Ethical Committee is obtained (S-20220039). Findings will be sought published in international scientific journals and shared among the participating hospitals and policymakers.
KW - Humans
KW - Pregnancy
KW - Female
KW - Registries
KW - Denmark/epidemiology
KW - Prospective Studies
KW - Pregnancy in Diabetics/epidemiology
KW - Pregnancy Outcome/epidemiology
KW - Glycated Hemoglobin/analysis
KW - Infant, Newborn
KW - Adult
KW - Risk Factors
KW - Prediabetic State/epidemiology
KW - Research Design
KW - Birth Weight
UR - http://www.scopus.com/inward/record.url?scp=85191618825&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2023-082237
DO - 10.1136/bmjopen-2023-082237
M3 - Journal article
C2 - 38670616
SN - 2044-6055
VL - 14
JO - BMJ Open
JF - BMJ Open
IS - 4
M1 - e082237
ER -