Fructosamines and Gestational Diabetes (FRUCTO)

Pregnancy Clinical Trial

— FRUCTO  

Official title:

Fructosamines and Gestational Diabetes (FRUCTO)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02159378
• Other study ID #: CHD008-14
• Status: Completed
• Phase: N/A
• First received: June 6, 2014
• Last updated: September 27, 2016
• Start date: July 2014
• Est. completion date: March 2016

Study information

• Verified date: September 2016
• Source: Centre Hospitalier Departemental Vendee
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertés
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes
• Pregnancy

Intervention

Other:
• Fructosamines

Locations

Country	Name	City	State
France	Centre hospitalier départemental Vendée	La Roche sur Yon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Departemental Vendee

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum fructosamine rate		at baseline (when gestational diabetes is diagnosed: between 24 and 28 weeks of gestation or later)	No