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Evaluation of Education for Gestational Diabetes

Completed
Conditions
Gestational Diabetes
Registration Number
NCT02528162
Lead Sponsor
Universitaire Ziekenhuizen KU Leuven
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
200
Inclusion Criteria
  • Women ≥ 18 years diagnosed with GDM in the university hospital Leuven.
Exclusion Criteria
  • Women who received bariatric surgery.
  • Women with pregestational diabetes or diagnosed with diabetes during early pregnancy.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Evaluation of the knowledge regarding GDM with a self-designed questionnaireover 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 Questionnaireover a 2-4 week period
Scale (1-4) with questionnaire on anxiety (six-item short form STAI)over a 2-4 week period
Secondary Outcome Measures
NameTimeMethod
The prevalence of GDM based on the IADPSG criteriaat 24-28 weeks of pregnancy
Composite endpoint of glycaemic control, weight, gestational weight gain and pregnancy outcomesover a period of 16 weeks
The frequency of insulin therapy for GDMover a period of 16 weeks
The time between the glucose challenge test and oral glucose tolerance testat 24-28 weeks of pregnancy
The frequency of an HbA1c ≥6.5%at 24-28 weeks of pregnancy

Trial Locations

Locations (1)

UZ Leuven

🇧🇪

Leuven, Belgium

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