NCT02945540

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 26, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

October 26, 2016

Status Verified

September 1, 2016

Enrollment Period

1 year

First QC Date

August 25, 2016

Last Update Submit

October 24, 2016

Conditions

Gestational Diabetes

Keywords

Gestational diabetesPatient educationPatient Satisfaction

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (8)

  • Blood glucose self-monitoring

    until birth (up to a maximum of 16 weeks)

  • weight gain

    during pregnancy until birth (up to a maximum of 16 weeks)

  • type of birth

    baseline

  • Measure of abdominal diameter

    before childbirth

  • Measure of fetal weight

    before childbirth

  • +3 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women with gestational diabetes and cared in therapeutic patient education

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caen University Hospital

Caen, 14033, France

RECRUITING

MeSH Terms

Conditions

Diabetes, GestationalPatient Satisfaction

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesTreatment Adherence and ComplianceHealth BehaviorBehavior

Central Study Contacts

Lidwine TRONCY, MSc

CONTACT

+33 2 31 06 30 23troncy-l@chu-caen.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2016

First Posted

October 26, 2016

Study Start

April 1, 2016

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

October 26, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)