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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02478762
Other study ID # 14-160
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


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
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