Fructosamines and Gestational Diabetes (FRUCTO)

Study Overview
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Brief Summary
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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

Official Title
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Fructosamines and Gestational Diabetes (FRUCTO)

Conditions
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Pregnancy, Gestational Diabetes

Intervention / Treatment
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* Other: Fructosamines


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: GD with Insulin treatment<br>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. | Other: Fructosamines<br> <br> |
| Other: GD without Insulin treatment<br>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. | Other: Fructosamines<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum fructosamine rate |  | at baseline (when gestational diabetes is diagnosed: between 24 and 28 weeks of gestation or later) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gestational Diabetes, Fructosamines, Insulin treatment