Gestational DiabetesNCT02528162
Evaluation of Education for Gestational Diabetes
An observational study of Gestational Diabetes, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2015to Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Women diagnosed with GDM based on the IADPSG criteria
Who may be able to join
- Women ≥ 18 years diagnosed with GDM in the university hospital Leuven.
Who cannot join
- Women who received bariatric surgery.
- Women with pregestational diabetes or diagnosed with diabetes during early pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Gestational Diabetes
- Being tested
- education
- Keywords
- gestational diabetes, education
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educationBehavioural
Evaluation of education for GDM
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the knowledge regarding GDM with a self-designed questionnaire
Measured: over a 2-4 week period
Scale (0 to 3) with questionnaire on depression (CES-D )
Measured: over a 2-4 week period
Evaluation of satisfaction with education and Diabetes Treatment Satisfaction Questionnaire
Measured: over a 2-4 week period
Scale (1-4) with questionnaire on anxiety (six-item short form STAI)
Measured: over a 2-4 week period
Secondary outcomes (5)
The prevalence of GDM based on the IADPSG criteria
Measured: at 24-28 weeks of pregnancy
Composite endpoint of glycaemic control, weight, gestational weight gain and pregnancy outcomes
Measured: over a period of 16 weeks
The frequency of insulin therapy for GDM
Measured: over a period of 16 weeks
The time between the glucose challenge test and oral glucose tolerance test
Measured: at 24-28 weeks of pregnancy
The frequency of an HbA1c ≥6.5%
Measured: at 24-28 weeks of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startOct 2015
- Primary completionMay 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02528162
- Sponsor's protocol ID
- the ELENA study
- Status last verified
- Nov 2017
- First submitted
- 6 Aug 2015
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Knowledge Regarding Gestational Diabetes and Evaluation of (Group) Education for Gestational Diabetes
- ClinicalTrials.gov ID
- NCT02528162
- Acronym / sponsor ID
- the ELENA study
- Conditions
- Gestational Diabetes
- Keywords
- gestational diabetes, education
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- May 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 19 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women diagnosed with GDM based on the IADPSG criteria
Key inclusion criteria (1 listed)
- Women ≥ 18 years diagnosed with GDM in the university hospital Leuven.
Key exclusion criteria (2 listed)
- Women who received bariatric surgery.
- Women with pregestational diabetes or diagnosed with diabetes during early pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| educationEvaluation of education for GDM | Behavioural | – |
Primary outcome
Evaluation of the knowledge regarding GDM with a self-designed questionnaire
Time frame: over a 2-4 week period
Scale (0 to 3) with questionnaire on depression (CES-D )
Time frame: over a 2-4 week period
Evaluation of satisfaction with education and Diabetes Treatment Satisfaction Questionnaire
Time frame: 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
5 secondary outcomes
The prevalence of GDM based on the IADPSG criteria
Time frame: 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
The frequency of insulin therapy for GDM
Time frame: 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
The frequency of an HbA1c ≥6.5%
Time frame: at 24-28 weeks of pregnancy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
Related trials for Gestational Diabetes
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Active, not recruitingPhase 2
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Weight Loss, Gestational Diabetes Mellitus in Pregnancy
Not yet recruiting
STRONG: SMART Trial
Gestational Diabetes Mellitus (GDM)
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the knowledge regarding GDM with a self-designed questionnaire (time frame: over a 2-4 week period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.