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| ID | Type | Description | Link |
|---|---|---|---|
| OG-3-08-2622-JA | Other Grant/Funding Number | Canadian Diabetes Association |
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| Name | Class |
|---|---|
| Canadian Diabetes Association | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant women 6-13 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 50 g oral glucose challenge test - 75 g oral glucose tolerance test | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 6-13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6-13 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Pregnant Women
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Luc Ardilouze, MD, PhD | Université de Sherbrooke | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de recherche clinique Étienne-Le Bel du CHUS | Sherbrooke | Quebec | J1H 5N4 | Canada |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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| ID | Term |
|---|---|
| D005951 | Glucose Tolerance Test |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008919 | Investigative Techniques |