Nationwide registry of pregnancies in women with diabetes
Danish Diabetes Birth Registry 2
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 |
|---|---|
| Enrollment | 2500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Odense University Hospital Academic / other |
| Locations | 4 sites (Aalborg and 3 other locations) |
| Trial ID | NCT05678543 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include women aged 18 and older with type 1 or type 2 diabetes, their partners, and their offspring.
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.
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 performed: Previous iterations of the Danish Diabetes Birth Registry have led to significant findings, indicating that this approach has a history of success.
Eligibility criteria
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 this trial is running
Aalborg and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.