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Estimate Rate of the Women Who Have Gestational Diabetes (ERD2-DIGERD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02852980
Recruitment Status : Completed
First Posted : August 2, 2016
Last Update Posted : July 29, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier René Dubos

Tracking Information
First Submitted Date July 29, 2016
First Posted Date August 2, 2016
Last Update Posted Date July 29, 2019
Study Start Date July 2015
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 1, 2016)
Glycemia realized after childbirth [ Time Frame: 3 months ]
The investigators want to know the number of women who realized a Glycemia analysis.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 1, 2016)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Estimate Rate of the Women Who Have Gestational Diabetes
Official Title 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
Brief Summary 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.
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
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Women who had childbirth in the Hospital center Rene Dubos and having gestational diabetes.
Condition Diabetes, Gestational
Intervention Other: gestational diabetes women
No intervention.
Study Groups/Cohorts gestational diabetes women
Women who had childbirth in the Hospital center Rene Dubos and who had gestational diabetes.
Intervention: Other: gestational diabetes women
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 9, 2017)
384
Original Estimated Enrollment
 (submitted: August 1, 2016)
500
Actual Study Completion Date January 2017
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02852980
Other Study ID Numbers CHRD1114
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Centre Hospitalier René Dubos
Study Sponsor Centre Hospitalier René Dubos
Collaborators Not Provided
Investigators
Principal Investigator: Catherine CAMPINOS, PH Rene Dubos Hospital
PRS Account Centre Hospitalier René Dubos
Verification Date July 2019