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Clinical Trials/NCT02528162
NCT02528162
Completed
Not Applicable

Evaluation of Knowledge Regarding Gestational Diabetes and Evaluation of (Group) Education for Gestational Diabetes

Universitaire Ziekenhuizen KU Leuven1 site in 1 country200 target enrollmentOctober 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gestational Diabetes
Sponsor
Universitaire Ziekenhuizen KU Leuven
Enrollment
200
Locations
1
Primary Endpoint
Evaluation of the knowledge regarding GDM with a self-designed questionnaire
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2015
End Date
June 2019
Last Updated
5 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Evaluation of the knowledge regarding GDM with a self-designed questionnaire

Time Frame: over a 2-4 week period

Scale (0 to 3) with questionnaire on depression (CES-D )

Time Frame: over a 2-4 week period

Evaluation of satisfaction with education and Diabetes Treatment Satisfaction Questionnaire

Time Frame: over a 2-4 week period

Scale (1-4) with questionnaire on anxiety (six-item short form STAI)

Time Frame: over a 2-4 week period

Secondary Outcomes

  • 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)

Study Sites (1)

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