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Evaluation of Education for Gestational Diabetes

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ClinicalTrials.gov Identifier: NCT02528162
Recruitment Status : Recruiting
First Posted : August 19, 2015
Last Update Posted : May 15, 2018
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen 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.

Condition or disease Intervention/treatment
Gestational Diabetes Behavioral: education

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Knowledge Regarding Gestational Diabetes and Evaluation of (Group) Education for Gestational Diabetes
Actual Study Start Date : October 2015
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Behavioral: education
    Evaluation of education for GDM


Primary Outcome Measures :
  1. Evaluation of the knowledge regarding GDM with a self-designed questionnaire [ Time Frame: over a 2-4 week period ]
  2. Scale (0 to 3) with questionnaire on depression (CES-D ) [ Time Frame: over a 2-4 week period ]
  3. Evaluation of satisfaction with education and Diabetes Treatment Satisfaction Questionnaire [ Time Frame: over a 2-4 week period ]
  4. Scale (1-4) with questionnaire on anxiety (six-item short form STAI) [ Time Frame: over a 2-4 week period ]

Secondary Outcome Measures :
  1. The prevalence of GDM based on the IADPSG criteria [ Time Frame: at 24-28 weeks of pregnancy ]
  2. Composite endpoint of glycaemic control, weight, gestational weight gain and pregnancy outcomes [ Time Frame: over a period of 16 weeks ]
  3. The frequency of insulin therapy for GDM [ Time Frame: over a period of 16 weeks ]
  4. The time between the glucose challenge test and oral glucose tolerance test [ Time Frame: at 24-28 weeks of pregnancy ]
  5. The frequency of an HbA1c ≥6.5% [ Time Frame: at 24-28 weeks of pregnancy ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women diagnosed with GDM based on the IADPSG criteria
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02528162


Contacts
Contact: Katrien Benhalima katrien.benhalima@uzleuven.be

Locations
Belgium
UZ Leuven Recruiting
Leuven, Belgium, 3000
Contact: Katrien Benhalima    474677153    katrien.benhalima@uzleuven.be   
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02528162     History of Changes
Other Study ID Numbers: the ELENA study
First Posted: August 19, 2015    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: November 2017

Keywords provided by Universitaire Ziekenhuizen Leuven:
gestational diabetes
education

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications