Reevaluation of the Glycemic Objectives of Women With Gestational Diabetes Mellitus
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Université de Sherbrooke
- Enrollment
- 5
- Locations
- 2
- Primary Endpoint
- Foetal glycated hemoglobin
Study Overview
Brief Summary
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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Normal glycemic control
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.
Intervention: Normal glycemic control (Procedure)
Low glycemic control
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.
Intervention: Low glycemic control (Procedure)
Outcomes
Primary Outcomes
Foetal glycated hemoglobin
Time Frame: At delivery
Secondary Outcomes
- Treatment satisfaction(End of pregnancy)
Investigators
Jean-Luc Ardilouze
Endocrinologist
Université de Sherbrooke