| NCT ID | NCT05678543 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Odense University Hospital |
| Condition | Pregnancy in Diabetic |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,500 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2027-12-31 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
Pregnancies in women with pre-existing diabetes are considered "high risk" pregnancies, poses daily clinical challenges and in terms of research - a number of unanswered questions. Therefore, the investigators wish to establish a nationwide cohort of pregnancies complicated by pre-existing diabetes - the Danish Diabetes Birth Registry (DDBR2) The DDBR2 registry comprises all types of pre-existing diabetes including T1D, T2D and other types (as MODY), generating a nationwide cohort of mother/partner/children trios with accessible registry-, clinical data and biological biobank samples. This will enable the investigators to use data longitudinally to examine short- and long-term outcomes of pregnancies in women with diabetes.
Eligibility Criteria
Inclusion Criteria: * Women, age ≥ 18 years * Type 1 diabetes, type 2 diabetes or other types of pre-existing diabetes (e.g., maturity onset diabetes of the young (MODY)) * Partners of women fulfilling these inclusion criteria, age ≥ 18 years * Offspring of women fulfilling these inclusion criteria Exclusion Criteria: * No proficiency in Danish or English to understand oral and written information