Glycemic Objectives of Women With Gestational Diabetes Mellitus

Phase 3

Terminated

• Conditions: Gestational Diabetes Mellitus
• Interventions: Procedure: Low glycemic control; Procedure: Normal glycemic control

• Registration Number: NCT02478762
• Lead Sponsor: Université de Sherbrooke

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-06-16
• Study First Submitted QC: 2015-06-18
• Study First Posted: 2015-06-23
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-02
• Last Update Posted: 2018-05-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low glycemic control	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.
Normal glycemic control	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.

Primary Outcome Measures

Name	Time	Method
Foetal glycated hemoglobin	At delivery

Secondary Outcome Measures

Name	Time	Method
Treatment satisfaction	End of pregnancy	Evaluated by questionnaire

Trial Locations

Locations (1)

Centre de recherche du Centre hospitalier universitaire de Sherbrooke; 🇨🇦 Sherbrooke, Quebec, Canada