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, Jori Aalders, Martin Overgaard...
https://pubmed.ncbi.nlm.nih.gov/38670616Actively Recruiting
Led by Odense University Hospital · Updated on 2024-04-12
2500
Participants Needed
4
Research Sites
156 weeks
Total Duration
Pregnancies in women with pre-existing diabetes, including type 1, type 2, and other types like MODY, are considered high risk and pose significant clinical challenges. The Danish Diabetes Birth Registry 2 (DDBR2) aims to create a nationwide cohort of these pregnancies to study both short- and long-term outcomes. This registry includes mother, partner, and child trios, combining registry, clinical data, and biological samples to better understand the impact of maternal diabetes on offspring health. The study collects extensive data from pregnant women with pre-existing diabetes, their partners, and offspring, including electronic patient records, continuous glucose monitoring data, ultrasound findings, and socioeconomic information. Biological samples are also gathered to explore genetic, epigenetic, and metabolic factors that may influence pregnancy outcomes and offspring health. The inclusion period runs from January 1, 2023, to December 31, 2027, with an expected 2,000 trios enrolled. Participants will be monitored throughout pregnancy and after delivery, with assessments including maternal HbA1c levels at 35 weeks, offspring birth weight adjusted for gestational age and gender, and continuous glucose monitoring metrics. Additional evaluations include maternal weight changes, pregnancy and birth complications, neonatal health, and quality of life measures. The study will use registry data, questionnaires, and biological analyses to identify predictors of maternal and neonatal outcomes and support future personalized treatments.
CONDITIONS
Danish Diabetes Birth Registry 2
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 years (from early pregnancy to 1 month postpartum and beyond for long-term follow-up)
Participants are observed throughout pregnancy with data collection including clinical data, continuous glucose monitoring, and questionnaires to assess maternal, partner, and offspring health outcomes.
Multiple visits during pregnancy and the first month after delivery
Duration - Up to several years post-delivery
Participants and their offspring are followed for long-term health outcomes using registry data and biological sample analyses.
Follow-up visits as needed and registry data collection
Total: 4 locations
1
Dept. of Obstetrics and Gynaecology, Aalborg University Hospital
Aalborg, Denmark, 9000
Actively Recruiting
2
Dept. of Obstetrics and Gynaecology, Aarhus Universitety Hospital
Aarhus, Denmark, 8200
Actively Recruiting
3
Center for Pregnant Women with Diabetes, Copenhagen University Hospital , Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
4
Dept. of Obstetrics and Gynaecology, Odense University Hospital
Odense, Denmark, 5000
Actively Recruiting
S
Sine K Johnsen, PhD
D
Dorte M Jensen, Prof.
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
Have more questions? Get in touch with our team for quick support
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Sine Knorr, Jori Aalders, Martin Overgaard...
https://pubmed.ncbi.nlm.nih.gov/38670616