| 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 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,500 participants in total. It began in 2023-01-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Dorte M Jensen, Prof.
PRINCIPAL INVESTIGATOR
Steno Diabetes Center Odense
Frequently Asked Questions
Who can join the NCT05678543 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pregnancy in Diabetic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05678543 currently recruiting?
Yes, NCT05678543 is actively recruiting participants. Contact the research team at sine.knorr@clin.au.dk for enrollment information.
Where is the NCT05678543 trial being conducted?
This trial is being conducted at Aalborg, Denmark, Aarhus, Denmark, Copenhagen, Denmark, Odense, Denmark.
Who is sponsoring the NCT05678543 clinical trial?
NCT05678543 is sponsored by Odense University Hospital. The principal investigator is Dorte M Jensen, Prof. at Steno Diabetes Center Odense. The trial plans to enroll 2,500 participants.