Nationwide registry of pregnancies in women with diabetes
Official title: Danish Diabetes Birth Registry 2
Run by Odense University Hospital · NCT05678543 · Data updated 2026-11-12
This study is trying to gather information about pregnancies in women with diabetes to see how their health and their babies' health are affected, and to find better ways to support them during and after pregnancy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 2500 (estimated) |
| Sponsor | Odense University Hospital Academic / other |
| Locations | 4 sites (Aalborg and 3 other locations) |
| Status | Recruiting |
| Started | January 1, 2023 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2030 |
| Registry record updated | April 12, 2024 |
| Trial ID | NCT05678543 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include women aged 18 and older with type 1 or type 2 diabetes, their partners, and their offspring.
✕Probably not a fit
Patients who do not speak Danish or English may not benefit from this study due to the requirement for understanding oral and written information.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The Danish Diabetes Birth Registry 2 aims to establish a comprehensive cohort of pregnancies complicated by pre-existing diabetes, including type 1 and type 2 diabetes. This observational study will collect registry, clinical data, and biological samples from mothers, partners, and children to analyze both short- and long-term outcomes of these pregnancies. By leveraging historical data from previous registries, the study seeks to address the clinical challenges faced by pregnant women with diabetes and improve personalized treatment approaches. The registry will also gather information on socioeconomic factors and partner involvement to enhance understanding of the overall context of these pregnancies.
Why it matters
Potential benefit: If successful, this registry could lead to improved management and outcomes for pregnancies in women with diabetes.
How similar studies have gone: Previous iterations of the Danish Diabetes Birth Registry have led to significant findings, indicating that this approach has a history of success.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Dept. of Obstetrics and Gynaecology, Aalborg University Hospital
Aalborg, Denmark Recruiting -
Dept. of Obstetrics and Gynaecology, Aarhus Universitety Hospital
Aarhus, Denmark Recruiting -
Center for Pregnant Women with Diabetes, Copenhagen University Hospital , Rigshospitalet
Copenhagen, Denmark Recruiting -
Dept. of Obstetrics and Gynaecology, Odense University Hospital
Odense, Denmark Recruiting
Study contacts
- Principal investigator: Dorte M Jensen, Prof. — Steno Diabetes Center Odense
- Study coordinator: Sine K Johnsen, PhD
- Email: sine.knorr@clin.au.dk
- Phone: +45 78 45 54 85
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.