Assessment of Patient Satisfaction Program "Gestational Diabetes"

• Conditions: Gestational Diabetes

• Registration Number: NCT02945540
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-08-25
• Status Verified: 2016-09
• Study First Submitted QC: 2016-10-24
• Last Update Submitted: 2016-10-24
• Study First Posted: 2016-10-26
• Last Update Posted: 2016-10-26
• Primary Completion: 2017-04
• Study Completion: 2017-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 350

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measuring patient satisfaction by a questionnaire on therapeutic education	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	baseline	Assessment of satisfaction between the 36th week of gestation and childbirth.

Secondary Outcome Measures

Name	Time	Method
Measure of fetal weight	before childbirth	Fetal Macrosomia suspected during fetal ultrasonography
Blood glucose self-monitoring	until birth (up to a maximum of 16 weeks)	control of diabetes by expected blood glucose targets
weight gain	during pregnancy until birth (up to a maximum of 16 weeks)
type of birth	baseline	Mode of parturition : Cesarean section or vaginal birth
Measure of abdominal diameter	before childbirth	Fetal Macrosomia suspected during fetal ultrasonography
Birth weight	at childbirth
Apgar score	1 minute and 5 minutes after birthchild
Neonatal blood glucose measurement	during the first 48 hours after birth	Number of neonatal hypoglycemia

Trial Locations

Locations (1)

Caen University Hospital; 🇫🇷 Caen, France