Evaluation of Education for Gestational Diabetes

November 3, 2020 updated by: Universitaire Ziekenhuizen KU Leuven

Evaluation of Knowledge Regarding Gestational Diabetes and Evaluation of (Group) 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • UZ Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women diagnosed with GDM based on the IADPSG criteria

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of the knowledge regarding GDM with a self-designed questionnaire
Time Frame: over a 2-4 week period
over a 2-4 week period
Scale (0 to 3) with questionnaire on depression (CES-D )
Time Frame: over a 2-4 week period
over a 2-4 week period
Evaluation of satisfaction with education and Diabetes Treatment Satisfaction Questionnaire
Time Frame: over a 2-4 week period
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
over a 2-4 week period

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

August 6, 2015

First Submitted That Met QC Criteria

August 17, 2015

First Posted (Estimate)

August 19, 2015

Study Record Updates

Last Update Posted (Actual)

November 4, 2020

Last Update Submitted That Met QC Criteria

November 3, 2020

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • the ELENA study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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