Fructosamines and Gestational Diabetes (FRUCTO)

Centre Hospitalier Departemental Vendee

Status: Completed

Conditions: Gestational Diabetes; Pregnancy

Treatments: Other: Fructosamines

Study type: Interventional

Funder types: Other

Identifiers

NCT02159378

CHD008-14

Details and patient eligibility

About

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

Enrollment: 200 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

GD with Insulin treatment

Other group

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.

Treatment:

Other: Fructosamines

GD without Insulin treatment

Other group

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.

Treatment:

Other: Fructosamines