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Fructosamines and Gestational Diabetes (FRUCTO) (FRUCTO)

Primary Purpose

Pregnancy, Gestational Diabetes

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Fructosamines
Sponsored by
Centre Hospitalier Departemental Vendee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pregnancy focused on measuring Gestational Diabetes, Fructosamines, Insulin treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥18 years
  • Ongoing pregnancy with a start date of pregnancy known and confirmed by an ultrasound of the 1st Quarter performed between 10 and 14 weeks with measurement of the crown-rump length
  • Hospitalization for a GD's discovery whatever the term of pregnancy (GD is defined with nationals recommendations of CNGOF)
  • Not opposed to participate in the study

Exclusion Criteria:

  • Pregnancy uncertain term (absence of early ultrasound)
  • Previous diabetes to the pregnancy (type 1 or 2)
  • Multiple Pregnancy
  • No affiliation to a social security scheme
  • Woman with a measure of legal protection

Sites / Locations

  • Centre hospitalier départemental Vendée

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

GD with Insulin treatment

GD without Insulin treatment

Arm Description

At the end of the study patients will be divided into two groups: "GD with Insulin treatment" versus "GD without Insulin treatment" In each group, the serum fructosamines rate will be estimated with a confidence interval of 95% and compared from a Student test.

At the end of the study patients will be divided into two groups: "GD with Insulin treatment" versus "GD without Insulin treatment" In each group, the serum fructosamines rate will be estimated with a confidence interval of 95% and compared from a Student test.

Outcomes

Primary Outcome Measures

Serum fructosamine rate

Secondary Outcome Measures

Full Information

First Posted
June 6, 2014
Last Updated
September 27, 2016
Sponsor
Centre Hospitalier Departemental Vendee
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1. Study Identification

Unique Protocol Identification Number
NCT02159378
Brief Title
Fructosamines and Gestational Diabetes (FRUCTO)
Acronym
FRUCTO
Official Title
Fructosamines and Gestational Diabetes (FRUCTO)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Departemental Vendee

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The prevalence of gestational diabetes is estimated at between 2 and 6%, but can be much higher in specific populations. The specific treatment of gestational diabetes (diet, control weight gain, self monitoring glucose , insulin therapy) reduces complications severe perinatal, fetal macrosomia, and preeclampsia compared with abstention therapy, without additional risk of caesarean section. Several early studies have shown that the determination of fructosamine is a very bad way of diagnosis for Gestational Diabetes. However, few studies have investigated the relationship between the determination of serum fructosamine and put under insulin in case of Gestational Diabetes. The purpose of this study is to determine if serum fructosamines rate can be a predictive marker of the starting insulin at the patients suffering from Gestational Diabetes

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Gestational Diabetes
Keywords
Gestational Diabetes, Fructosamines, Insulin treatment

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GD with Insulin treatment
Arm Type
Other
Arm Description
At the end of the study patients will be divided into two groups: "GD with Insulin treatment" versus "GD without Insulin treatment" In each group, the serum fructosamines rate will be estimated with a confidence interval of 95% and compared from a Student test.
Arm Title
GD without Insulin treatment
Arm Type
Other
Arm Description
At the end of the study patients will be divided into two groups: "GD with Insulin treatment" versus "GD without Insulin treatment" In each group, the serum fructosamines rate will be estimated with a confidence interval of 95% and compared from a Student test.
Intervention Type
Other
Intervention Name(s)
Fructosamines
Primary Outcome Measure Information:
Title
Serum fructosamine rate
Time Frame
at baseline (when gestational diabetes is diagnosed: between 24 and 28 weeks of gestation or later)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 years Ongoing pregnancy with a start date of pregnancy known and confirmed by an ultrasound of the 1st Quarter performed between 10 and 14 weeks with measurement of the crown-rump length Hospitalization for a GD's discovery whatever the term of pregnancy (GD is defined with nationals recommendations of CNGOF) Not opposed to participate in the study Exclusion Criteria: Pregnancy uncertain term (absence of early ultrasound) Previous diabetes to the pregnancy (type 1 or 2) Multiple Pregnancy No affiliation to a social security scheme Woman with a measure of legal protection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillaume DUCARME, PH
Organizational Affiliation
Centre Hospitalier Départemental Vendée
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre hospitalier départemental Vendée
City
La Roche sur Yon
ZIP/Postal Code
85925
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
30578686
Citation
Ducarme G, Desroys du Roure F, Grange J, Vital M, Le Thuaut A, Crespin-Delcourt I. Predictive factors of subsequent insulin requirement for glycemic control during pregnancy at diagnosis of gestational diabetes mellitus. Int J Gynaecol Obstet. 2019 Mar;144(3):265-270. doi: 10.1002/ijgo.12753. Epub 2019 Jan 11.
Results Reference
derived

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Fructosamines and Gestational Diabetes (FRUCTO)

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