Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID05678543

Danish Diabetes Birth Registry 2 A Nationwide Cohort Study of Pregnancies Complicated by Pre-existing Diabetes Including Mothers, Partners, and Offspring

Led by Odense University Hospital · Updated on 2024-04-12

2500

Participants Needed

4

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Brief Title

Danish Diabetes Birth Registry 2

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 18 years or older
  • Diagnosed with type 1 diabetes, type 2 diabetes, or other types of pre-existing diabetes such as MODY
  • Partners of women who meet these diabetes criteria, aged 18 years or older
  • Offspring of women who meet these diabetes criteria
Not Eligible

You will not qualify if you...

  • Unable to understand spoken or written Danish or English

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

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

Long-term Monitoring

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

Trial Site Locations

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

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Research Team

S

Sine K Johnsen, PhD

D

Dorte M Jensen, Prof.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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Published Research Related To This Trial

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/38670616