Glycemic Objectives of Women With Gestational Diabetes Mellitus

Study Overview
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Brief Summary
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In a previous study, the investigators established the dosage of foetal glycated hemoglobin (FGH). It represents the mean of blood sugar 4-6 before the delivery. The investigators also compared the FGH of newborn of women with and without gestational diabetes mellitus (GDM) and determined that newborn of women with GDM had significantly higher FGH that newborn of women without GDM. In this study, the investigators want to compare the FGH of newborn of GDM women randomized to a group reaching the Canadian Diabetes Association recommended blood glucose objectives treatment (fasting: 5.3 mmol/L and 2-hour after meals: 6.7 mmol/L) to a group reaching lower blood glucose objectives (fasting: 4.8 mmol/L and 2-hour after meals: 5.9 mmol/L)

Official Title
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Reevaluation of the Glycemic Objectives of Women With Gestational Diabetes Mellitus

Conditions
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Gestational Diabetes Mellitus

Intervention / Treatment
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* Procedure: Normal glycemic control
* Procedure: Low glycemic control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: gestational age between 15 and 32 weeks since last menstrual date, received education on gestational diabetes mellitus, able to read and understand French. Exclusion Criteria: known type 1 or type 2 diabetes, treatment interfering woth glucose metabolism, deficit may hinder the understanding of the study.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Normal glycemic control<br>GDM women in this group will reach glycemic objectives recommended by the Canadian Diabetes Association: fasting: 5.3 mmol/L and 2-hour after meals: 6.7 mmol/L. | Procedure: Normal glycemic control<br>* Use diet, physical exercise of insulins to reach normal glycemic control.<br>|
| Experimental: Low glycemic control<br>GDM women in this group will reach lower glycemic objectives than those recommended by the Canadian Diabetes Association: fasting: 4.8 mmol/L and 2-hour after meals: 5.9 mmol/L. | Procedure: Low glycemic control<br>* Use diet, physical exercise of insulins to reach low glycemic control.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Foetal glycated hemoglobin |  | At delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment satisfaction | Evaluated by questionnaire | End of pregnancy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glycemic objectives treatment, Foetal glycated hemoglobin