Glycemic Objectives of Women With Gestational Diabetes Mellitus

Gestational Diabetes Mellitus Clinical Trial

Official title:

Reevaluation of the Glycemic Objectives of Women With Gestational Diabetes Mellitus

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02478762
• Other study ID #: 14-160
• Status: Terminated
• Phase: Phase 3
• Start date: March 2015
• Est. completion date: December 2016

Study information

• Verified date: May 2018
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus

Intervention

Procedure:
• Normal glycemic control
Use diet, physical exercise of insulins to reach normal glycemic control.
• Low glycemic control
Use diet, physical exercise of insulins to reach low glycemic control.

Locations

Country	Name	City	State
Canada	Centre de recherche du Centre hospitalier universitaire de Sherbrooke	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Foetal glycated hemoglobin		At delivery
Secondary	Treatment satisfaction	Evaluated by questionnaire	End of pregnancy