Evaluation of Education for Gestational Diabetes

Gestational Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02528162
• Other study ID #: the ELENA study
• Status: Completed
• Start date: October 2015
• Est. completion date: June 2019

Study information

• Verified date: November 2017
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

Intervention

Behavioral:
• education
Evaluation of education for GDM

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the knowledge regarding GDM with a self-designed questionnaire		over a 2-4 week period
Primary	Scale (0 to 3) with questionnaire on depression (CES-D )		over a 2-4 week period
Primary	Evaluation of satisfaction with education and Diabetes Treatment Satisfaction Questionnaire		over a 2-4 week period
Primary	Scale (1-4) with questionnaire on anxiety (six-item short form STAI)		over a 2-4 week period
Secondary	The prevalence of GDM based on the IADPSG criteria		at 24-28 weeks of pregnancy
Secondary	Composite endpoint of glycaemic control, weight, gestational weight gain and pregnancy outcomes		over a period of 16 weeks
Secondary	The frequency of insulin therapy for GDM		over a period of 16 weeks
Secondary	The time between the glucose challenge test and oral glucose tolerance test		at 24-28 weeks of pregnancy
Secondary	The frequency of an HbA1c =6.5%		at 24-28 weeks of pregnancy