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NCT Number: NCT02528162

Evaluation of Education for Gestational Diabetes

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.

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Key information

Conditions

Gestational Diabetes Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

UZ Leuven

Leuven, 3000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Education

Behavioral

Evaluation of education for GDM

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Aug 19, 2015
Registry last updated
Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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