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Assessment of Patient Satisfaction Program "Gestational Diabetes" (SATISFYDG)

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ClinicalTrials.gov Identifier: NCT02945540
Recruitment Status : Unknown
Verified September 2016 by University Hospital, Caen.
Recruitment status was:  Recruiting
First Posted : October 26, 2016
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

Brief 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 . 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.


Condition or disease
Gestational Diabetes

Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Patient Satisfaction Supported in the Patient Education Program "Gestational Diabetes" at the University Hospital of Caen
Study Start Date : April 2016
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Blood glucose self-monitoring [ Time Frame: until birth (up to a maximum of 16 weeks) ]
    control of diabetes by expected blood glucose targets

  2. weight gain [ Time Frame: during pregnancy until birth (up to a maximum of 16 weeks) ]
  3. type of birth [ Time Frame: baseline ]
    Mode of parturition : Cesarean section or vaginal birth

  4. Measure of abdominal diameter [ Time Frame: before childbirth ]
    Fetal Macrosomia suspected during fetal ultrasonography

  5. Measure of fetal weight [ Time Frame: before childbirth ]
    Fetal Macrosomia suspected during fetal ultrasonography

  6. Birth weight [ Time Frame: at childbirth ]
  7. Apgar score [ Time Frame: 1 minute and 5 minutes after birthchild ]
  8. Neonatal blood glucose measurement [ Time Frame: during the first 48 hours after birth ]
    Number of neonatal hypoglycemia



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women with gestational diabetes and cared in therapeutic patient education
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02945540


Contacts
Contact: Lidwine TRONCY, MSc +33 2 31 06 30 23 troncy-l@chu-caen.fr

Locations
France
Caen University Hospital Recruiting
Caen, France, 14033
Contact: Lidwine TRONCY, MSc    +33 2 31 06 30 23    troncy-l@chu-caen.fr   
Sponsors and Collaborators
University Hospital, Caen

Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT02945540     History of Changes
Other Study ID Numbers: 15-198
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital, Caen:
Gestational diabetes
Patient education
Patient Satisfaction

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications