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Glycemic Objectives of Women With Gestational Diabetes Mellitus

Reevaluation of the Glycemic Objectives of Women With Gestational Diabetes Mellitus

Status
Terminated
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02478762
Enrollment
5
Registered
2015-06-23
Start date
2015-03-31
Completion date
2016-12-31
Last updated
2018-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes Mellitus

Keywords

Foetal glycated hemoglobin, Glycemic objectives treatment

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)

Interventions

PROCEDURENormal glycemic control

Use diet, physical exercise of insulins to reach normal glycemic control.

PROCEDURELow glycemic control

Use diet, physical exercise of insulins to reach low glycemic control.

Sponsors

Université de Sherbrooke
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frame
Foetal glycated hemoglobinAt delivery

Secondary

MeasureTime frameDescription
Treatment satisfactionEnd of pregnancyEvaluated by questionnaire

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026