- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02852980
Estimate Rate of the Women Who Have Gestational Diabetes (ERD2-DIGERD)
July 26, 2019 updated by: Centre Hospitalier René Dubos
Retrospective Study to Estimate Screening of the Type 2 Diabetes of Women Who Had Childbirth in the Hospital Center Rene Dubos and Having Gestational Diabetes
Retrospective study to estimate screening of the type 2 diabetes of women who had childbirth in the Hospital center Rene Dubos and having gestational diabetes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
It is recognized that pregnant women who had gestational diabetes (DG) multiplied by 7 subsequent risk of developing type 2 diabetes and this during 25 years.
There is at present no formal recommendation of the High Authority for Health (HAS) as an organization of a long term screening for those women.
However the recommendations of CNGOF (French Council of Gynaecologists and Obstetricians) and SFD (French society of diabetes) recommend screening for type 2 diabetes after a gestational diabetes in the postnatal consultation.
But today how many women views due to a gestational diabetes have realized their screening?
It is likely that the rate of occurrence of type 2 diabetes after gestational diabetes is underestimated today.
Otherwise it is possible that the occurrence of type 2 diabetes is associated with some risk factors such as high BMI, insulin therapy during pregnancy.
Another interrogation is the role of the doctor to reduce the number of women who do not realize their screening at 3 months postpartum.
Better awareness of the importance of long term monitoring would reduce the proportion of women who do not realize their screening.
Study Type
Observational
Enrollment (Actual)
384
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Val d'Oise
-
Pontoise, Val d'Oise, France, 95303
- Rene Dubos Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Women who had childbirth in the Hospital center Rene Dubos and having gestational diabetes.
Description
Inclusion Criteria:
- Participants aged over 18 years
- Participants who deliver between 01/01/2013 and 30/06/2015
- Participants who have had a gestational diabetes
- Participants who have been informed and have returned the questionary
Exclusion Criteria:
- Participants who do not wishing to participate in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
gestational diabetes women
Women who had childbirth in the Hospital center Rene Dubos and who had gestational diabetes.
|
No intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Glycemia realized after childbirth
Time Frame: 3 months
|
The investigators want to know the number of women who realized a Glycemia analysis.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of women who have pursued the dietary and hygiene rules
Time Frame: 3 months
|
Information about dietary and hygiene rules are collected on a questionnaire.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Catherine CAMPINOS, PH, Rene Dubos Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2015
Primary Completion (Actual)
January 1, 2017
Study Completion (Actual)
January 1, 2017
Study Registration Dates
First Submitted
July 29, 2016
First Submitted That Met QC Criteria
August 1, 2016
First Posted (Estimate)
August 2, 2016
Study Record Updates
Last Update Posted (Actual)
July 29, 2019
Last Update Submitted That Met QC Criteria
July 26, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHRD1114
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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