Gestational Diabetes Mellitus
Conditions
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.
Interventions
PROCEDURE50 g oral glucose challenge test - 75 g oral glucose tolerance test
50 g oral glucose challenge test at 6-13 weeks of gestation and 75 g oral glucose tolerance test at 24-28 weeks of gestation.
Sponsors
Canadian Diabetes Association
Université de Sherbrooke
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| oral glucose challenge test plasma glucose value | 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
| Measure | Time frame | Description |
|---|---|---|
| oral glucose challenge test plasma glucose cut-off value | 6-13 weeks | 1st trimester 1h post 50g oral glucose challenge test plasma glucose cut-off value that offers optimal sensibility and specificity compared to the 75g oral glucose tolerance test performed between the 24th and 28th weeks of gestation, based on the ROC curve and the maximal likelihood ratio for a positive test. |
Countries
Canada
Outcome results
None listed