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. 2024 Apr 25;14(4):e082237.
doi: 10.1136/bmjopen-2023-082237.

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

Sine Knorr  1   2 , Jori Aalders  3   4 , Martin Overgaard  4   5 , Henrik Støvring  6 , Elisabeth R Mathiesen  7   8 , Peter Damm  8   9 , Tine D Clausen  9 , Ulla Bjerre-Christensen  10 , Lise Lotte T Andersen  11 , Christina Vinter  3   4   11 , Allan Kofoed-Enevoldsen  12 , Jeannet Lauenborg  13 , Ulla Kampmann  6   2 , Jens Fuglsang  6   2   14 , Per G Ovesen  6   2   14 , Trine T Christensen  15 , Anne Sørensen  16   17 , Lene Ringholm  7   8 , Dorte M Jensen  3   4
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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

Sine Knorr et al. BMJ Open. .

Abstract

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.

Trial registration number: NCT05678543.

Keywords: DIABETES & ENDOCRINOLOGY; Diabetes in pregnancy; GENETICS; OBSTETRICS; Obesity; Paediatric endocrinology.

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Conflict of interest statement

Competing interests: SK: None. JA: None. MO: MO holds stocks in Novo Nordisk. HS: None. ERM: ERM has participated in clinical studies on the use of insulin in pregnant women with pre-existing diabetes in collaboration with Novo Nordisk. Papers from these studies are still being produced. No personal honorarium was involved. LR: LR has received a grant from Novo Nordisk A/S for an investigator-sponsored study. Grant number: U1111-1209-6358. LR participated in the European Association for the Study of Diabetes annual meeting 2023 as an invite by Novo Nordisk. PD: PD has participated in clinical studies on the use of insulin in pregnant women with pre-existing diabetes in collaboration with Novo Nordisk. Papers from these studies are still being produced. No personal honorarium was involved. TDC: TDC has participated in clinical studies on the use of insulin in pregnant women with pre-existing diabetes in collaboration with Novo Nordisk. Papers from these studies are still being produced. No personal honorarium was involved. UB-C: None. AK-E: None. JL: None. LLTA: None. CV: None. UK: None. JF: JF holds stocks in Novo Nordisk. PGO: None. TTC: TTC participated in the European Association for the Study of Diabetes annual meeting 2023 as an invite by Novo Nordisk. AS: None. DMJ: None.

Figures

Figure 1
Figure 1
The figure is divided in two, displaying the organisation of standard visits for a pregnant woman with pre-existing diabetes in Denmark at the top and below, the additional visits and data collection included in the Danish Diabetes Birth Registry 2. 1Early pregnancy questionnaire (sent out directly after the first study visit). 2Late pregnancy questionnaire (sent out at 26 weeks—based on expected due date inclusion). 3After birth questionnaire (sent out 3 weeks after birth) 4Background questionnaire (sent out directly after inclusion).
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References

    1. Murphy HR, Howgate C, O’Keefe J, et al. . Characteristics and outcomes of pregnant women with type 1 or type 2 diabetes: a 5-year national population-based cohort study. The Lancet Diabetes & Endocrinology 2021;9:153–64. 10.1016/S2213-8587(20)30406-X - DOI - PubMed
    1. Macintosh MCM, Fleming KM, Bailey JA, et al. . Perinatal mortality and congenital anomalies in babies of women with type 1 or type 2 diabetes in England, Wales, and northern Ireland: population based study. BMJ 2006;333:177. 10.1136/bmj.38856.692986.AE - DOI - PMC - PubMed
    1. Penney GC, Mair G, Pearson DWM, et al. . Outcomes of pregnancies in women with type 1 diabetes in Scotland: A national population-based study. BJOG 2003;110:315–8. - PubMed
    1. Yang J, Cummings EA, OʼConnell C, et al. . Fetal and neonatal outcomes of diabetic pregnancies. Obstetrics & Gynecology 2006;108:644–50. 10.1097/01.AOG.0000231688.08263.47 - DOI - PubMed
    1. Verheijen ECJ, Critchley JA, Whitelaw DC, et al. . Outcomes of pregnancies in women with pre-existing type 1 or type 2 diabetes, in an ethnically mixed population. BJOG 2005;112:1500–3. 10.1111/j.1471-0528.2005.00747.x - DOI - PubMed

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