NCT02528162

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 19, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2017

Enrollment Period

3.6 years

First QC Date

August 6, 2015

Last Update Submit

November 3, 2020

Conditions

Keywords

gestational diabeteseducation

Outcome Measures

Primary Outcomes (4)

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

    over a 2-4 week period

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

    over a 2-4 week period

  • Evaluation of satisfaction with education and Diabetes Treatment Satisfaction Questionnaire

    over a 2-4 week period

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

    over a 2-4 week period

Secondary Outcomes (5)

  • 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

Interventions

educationBEHAVIORAL

Evaluation of education for GDM

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women diagnosed with GDM based on the IADPSG criteria

You may qualify if:

  • Women ≥ 18 years diagnosed with GDM in the university hospital Leuven.

You may not qualify if:

  • Women who received bariatric surgery.
  • Women with pregestational diabetes or diagnosed with diabetes during early pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2015

First Posted

August 19, 2015

Study Start

October 1, 2015

Primary Completion

May 1, 2019

Study Completion

June 1, 2019

Last Updated

November 4, 2020

Record last verified: 2017-11

Locations