Evaluation of Education for Gestational Diabetes
Evaluation of Knowledge Regarding Gestational Diabetes and Evaluation of (Group) Education for Gestational Diabetes
1 other identifier
observational
200
1 country
1
Brief Summary
Prospective observational cohort study of women with gestational diabetes (GDM) based on the 'International Association of Pregnancy Study Groups' (IADPSG) criteria. The overall aim is to evaluate the knowledge regarding GDM of women with GDM and to evaluate the satisfaction of women with GDM about the education they receive (given in group or individually). Normal routine care is followed and evaluated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2015
CompletedFirst Posted
Study publicly available on registry
August 19, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedNovember 4, 2020
November 1, 2017
3.6 years
August 6, 2015
November 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Evaluation of the knowledge regarding GDM with a self-designed questionnaire
over a 2-4 week period
Scale (0 to 3) with questionnaire on depression (CES-D )
over a 2-4 week period
Evaluation of satisfaction with education and Diabetes Treatment Satisfaction Questionnaire
over a 2-4 week period
Scale (1-4) with questionnaire on anxiety (six-item short form STAI)
over a 2-4 week period
Secondary Outcomes (5)
The prevalence of GDM based on the IADPSG criteria
at 24-28 weeks of pregnancy
Composite endpoint of glycaemic control, weight, gestational weight gain and pregnancy outcomes
over a period of 16 weeks
The frequency of insulin therapy for GDM
over a period of 16 weeks
The time between the glucose challenge test and oral glucose tolerance test
at 24-28 weeks of pregnancy
The frequency of an HbA1c ≥6.5%
at 24-28 weeks of pregnancy
Interventions
Evaluation of education for GDM
Eligibility Criteria
Women diagnosed with GDM based on the IADPSG criteria
You may qualify if:
- Women ≥ 18 years diagnosed with GDM in the university hospital Leuven.
You may not qualify if:
- Women who received bariatric surgery.
- Women with pregestational diabetes or diagnosed with diabetes during early pregnancy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UZ Leuven
Leuven, 3000, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2015
First Posted
August 19, 2015
Study Start
October 1, 2015
Primary Completion
May 1, 2019
Study Completion
June 1, 2019
Last Updated
November 4, 2020
Record last verified: 2017-11