Gestational DiabetesSATISFYDGNCT02945540
Assessment of Patient Satisfaction Program "Gestational Diabetes"
An observational study of Gestational Diabetes, run by University Hospital, Caen at 1 site in France.
Trial summary
This study seeks to evaluate patient satisfaction within the patient therapeutic education program "gestational diabetes" (multidisciplinary and multi-professional program) to see if they deem effective to limit the impact of gestational diabetes on pregnancy . Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes
- How many people
- 350 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2016to Apr 2017
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women with gestational diabetes and cared in therapeutic patient education
Who may be able to join
- pregnant women
- Gestational diabetes diagnosis based on OGTT glucose 75g, performed after 24 weeks of gestation
- Women aged 18 and over
- After 24th week of gestation
- Before 36th week of gestation
- initial management in therapeutic education at the University Hospital of Caen
Who cannot join
- Another form of diabetes (existing before pregnancy or diagnosed before 24 weeks of gestation)
- women under 18 years
- Initial management of gestational diabetes by health professionals outside the University Hospital of Caen
- Poor understanding of the French language
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Caen University Hospital
Caen, 14033
Lidwine TRONCY, MSc, +33 2 31 06 30 23, troncy-l@chu-caen.fr
About this study
Official title: Assessment of Patient Satisfaction Supported in the Patient Education Program "Gestational Diabetes" at the University Hospital of Caen
This study seeks to evaluate patient satisfaction within the patient therapeutic education program "gestational diabetes" (multidisciplinary and multi-professional program) to see if they deem effective to limit the impact of gestational diabetes on pregnancy . Patients are questioned on the skills acquired in everyday life, the effective support in personal development, development of self-determination capabilities and communication with health professionals.
This study must include all patients participating in the therapeutic education program for a year and meeting the inclusion criteria.
- Conditions
- Gestational Diabetes
- Keywords
- Gestational diabetes, Patient education, Patient Satisfaction
- Medical subject headings
- Diabetes, Gestational, Patient Satisfaction
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring patient satisfaction by a questionnaire on therapeutic education
Evaluation of satisfaction the entry into the program, after the diagnosis, until the 36th week of gestation.
Measured: 36th week of gestation
Measuring patient satisfaction at childbirth by a questionnaire on satisfaction of hospital care
Assessment of satisfaction between the 36th week of gestation and childbirth.
Measured: baseline
Secondary outcomes (8)
Blood glucose self-monitoring
control of diabetes by expected blood glucose targets
Measured: until birth (up to a maximum of 16 weeks)
weight gain
Measured: during pregnancy until birth (up to a maximum of 16 weeks)
type of birth
Mode of parturition : Cesarean section or vaginal birth
Measured: baseline
Measure of abdominal diameter
Fetal Macrosomia suspected during fetal ultrasonography
Measured: before childbirth
Measure of fetal weight
Fetal Macrosomia suspected during fetal ultrasonography
Measured: before childbirth
Birth weight
Measured: at childbirth
Apgar score
Measured: 1 minute and 5 minutes after birthchild
Neonatal blood glucose measurement
Number of neonatal hypoglycemia
Measured: during the first 48 hours after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2017 (estimated)
- Study completionApr 2017 (estimated)
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 University Hospital, CaenThe 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
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02945540
- Sponsor's protocol ID
- 15-198
- Acronym
- SATISFYDG
- Status last verified
- Sep 2016
- First submitted
- 25 Aug 2016
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Patient Satisfaction Supported in the Patient Education Program "Gestational Diabetes" at the University Hospital of Caen
- ClinicalTrials.gov ID
- NCT02945540
- Acronym / sponsor ID
- SATISFYDG / 15-198
- Conditions
- Gestational Diabetes
- Keywords
- Gestational diabetes, Patient education, Patient Satisfaction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 26 Oct 2016 (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.
This study seeks to evaluate patient satisfaction within the patient therapeutic education program "gestational diabetes" (multidisciplinary and multi-professional program) to see if they deem effective to limit the impact of gestational diabetes on pregnancy . Patients are questioned on the skills acquired in everyday life, the effective support in personal development, development of self-determination capabilities and communication with health professionals.
This study must include all patients participating in the therapeutic education program for a year and meeting the inclusion criteria.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women with gestational diabetes and cared in therapeutic patient education
Key inclusion criteria (6 listed)
- pregnant women
- Gestational diabetes diagnosis based on OGTT glucose 75g, performed after 24 weeks of gestation
- Women aged 18 and over
- After 24th week of gestation
- Before 36th week of gestation
Key exclusion criteria (4 listed)
- Another form of diabetes (existing before pregnancy or diagnosed before 24 weeks of gestation)
- women under 18 years
- Initial management of gestational diabetes by health professionals outside the University Hospital of Caen
- Poor understanding of the French language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measuring patient satisfaction by a questionnaire on therapeutic education
Time frame: 36th week of gestation
Evaluation of satisfaction the entry into the program, after the diagnosis, until the 36th week of gestation.
Measuring patient satisfaction at childbirth by a questionnaire on satisfaction of hospital care
Time frame: baseline
Assessment of satisfaction between the 36th week of gestation and childbirth.
8 secondary outcomes
Blood glucose self-monitoring
Time frame: until birth (up to a maximum of 16 weeks)
weight gain
Time frame: during pregnancy until birth (up to a maximum of 16 weeks)
type of birth
Time frame: baseline
Measure of abdominal diameter
Time frame: before childbirth
Measure of fetal weight
Time frame: before childbirth
Birth weight
Time frame: at childbirth
Apgar score
Time frame: 1 minute and 5 minutes after birthchild
Neonatal blood glucose measurement
Time frame: during the first 48 hours after birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
- Individual participant dataSharing planned: No
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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.
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 University Hospital, Caen at 1 site in France.
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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 26 Oct 2016. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lidwine TRONCY, MSc (+33 2 31 06 30 23, troncy-l@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring patient satisfaction by a questionnaire on therapeutic education (time frame: 36th week of gestation). The study lists 2 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 26 Oct 2016.