Early Screening for Gestational Diabetes Mellitus
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gestational Diabetes Mellitus
- Sponsor
- Université de Sherbrooke
- Enrollment
- 1442
- Locations
- 1
- Primary Endpoint
- oral glucose challenge test plasma glucose value
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The working hypothesis of this proposal is that screening for gestational diabetes mellitus as early as the 1st trimester is efficient for detecting the forthcoming presence or absence of gestational diabetes mellitus. The investigators long-term goal is the prevention of gestational diabetes mellitus onset i.e. the prevention of progression to gestational diabetes mellitus, in order to enable delivery of appropriate counselling, diagnostics and treatment for pregnant women, as well as to improve pregnancy outcomes. Therefore, robust 1st trimester screening criteria is needed.
The overall objective of this proposal is to determine an accurate and valid 1st trimester 1h post 50g oral glucose challenge test plasma glucose cut-off value that is predictive of gestational diabetes mellitus onset.
Investigators
Jean-Luc Ardilouze
Endocrinologist, researcher
Université de Sherbrooke
Eligibility Criteria
Inclusion Criteria
- •Age \> 18 yrs
- •Gestational age between 6 and 13 weeks from last menstrual period,
- •Alcohol \< 2 drinks/day
- •Not involved in regular high intensity physical activity
- •Singleton pregnancy
- •Otherwise good health status.
Exclusion Criteria
- •Type 1 or type 2 diabetes
- •Taking drugs interfering with glucose metabolism
Outcomes
Primary Outcomes
oral glucose challenge test plasma glucose value
Time Frame: 6-13 weeks
the sensitivity, specificity, positive and negative predictive values of oral glucose challenge test plasma glucose \>= 7.8 mmol/L during the 1st trimester (6-13 weeks of gestation), as compared with fasting 75g glucose oral glucose tolerance test performed between the 24th and 28th weeks of gestation (the Canadian Diabetes Association - CDA gold standard).
Secondary Outcomes
- oral glucose challenge test plasma glucose cut-off value(6-13 weeks)