Assessment of Patient Satisfaction Program "Gestational Diabetes"

Gestational Diabetes Clinical Trial

— SATISFYDG  

Official title:

Assessment of Patient Satisfaction Supported in the Patient Education Program "Gestational Diabetes" at the University Hospital of Caen

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02945540
• Other study ID #: 15-198
• Status: Recruiting
• Phase: N/A
• First received: August 25, 2016
• Last updated: October 24, 2016
• Start date: April 2016
• Est. completion date: April 2017

Study information

• Verified date: September 2016
• Source: University Hospital, Caen
• Contact: Lidwine TRONCY, MSc
• Phone: +33 2 31 06 30 23
• Email: troncy-l[@]chu-caen.fr
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Observational

Clinical 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 . 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

Locations

Country	Name	City	State
France	Caen University Hospital	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	36th week of gestation	No
Primary	Measuring patient satisfaction at childbirth by a questionnaire on satisfaction of hospital care	Assessment of satisfaction between the 36th week of gestation and childbirth.	baseline	No
Secondary	Blood glucose self-monitoring	control of diabetes by expected blood glucose targets	until birth (up to a maximum of 16 weeks)	No
Secondary	weight gain		during pregnancy until birth (up to a maximum of 16 weeks)	No
Secondary	type of birth	Mode of parturition : Cesarean section or vaginal birth	baseline	No
Secondary	Measure of abdominal diameter	Fetal Macrosomia suspected during fetal ultrasonography	before childbirth	No
Secondary	Measure of fetal weight	Fetal Macrosomia suspected during fetal ultrasonography	before childbirth	No
Secondary	Birth weight		at childbirth	No
Secondary	Apgar score		1 minute and 5 minutes after birthchild	No
Secondary	Neonatal blood glucose measurement	Number of neonatal hypoglycemia	during the first 48 hours after birth	No