Early Screening for Gestational Diabetes Mellitus

Université de Sherbrooke1,442 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,442

Conditions

Gestational Diabetes Mellitus

Interventions

50 g oral glucose challenge test - 75 g oral glucose tolerance testPROCEDURE

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

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).

Time frame: 6-13 weeks

Secondary Outcomes

oral glucose challenge test plasma glucose cut-off value

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.