Early Screening for Gestational Diabetes Mellitus (DG2)
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|ClinicalTrials.gov Identifier: NCT01026675|
Recruitment Status : Completed
First Posted : December 4, 2009
Last Update Posted : December 23, 2016
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.
|Condition or disease||Intervention/treatment|
|Gestational Diabetes Mellitus||Procedure: 50 g oral glucose challenge test - 75 g oral glucose tolerance test|
|Study Type :||Observational|
|Actual Enrollment :||1442 participants|
|Official Title:||Early Screening for Gestational Diabetes Mellitus|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||May 2013|
|Pregnant women 6-13 weeks||
Procedure: 50 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.
- 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).
- oral glucose challenge test plasma glucose cut-off value [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01026675
|Centre de recherche clinique Étienne-Le Bel du CHUS|
|Sherbrooke, Quebec, Canada, J1H 5N4|
|Principal Investigator:||Jean-Luc Ardilouze, MD, PhD||Université de Sherbrooke|