Early Screening for Gestational Diabetes Mellitus

Completed

• Conditions: Gestational Diabetes Mellitus
• Interventions: Procedure: 50 g oral glucose challenge test - 75 g oral glucose tolerance test

• Registration Number: NCT01026675
• Lead Sponsor: Université de Sherbrooke

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-12-03
• Study First Submitted QC: 2009-12-03
• Study First Posted: 2009-12-04
• Primary Completion: 2012-12
• Study Completion: 2013-05
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-02
• Last Update Posted: 2018-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1442

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.

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Exclusion Criteria

• Type 1 or type 2 diabetes
• Taking drugs interfering with glucose metabolism

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant women 6-13 weeks	50 g oral glucose challenge test - 75 g oral glucose tolerance test	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Centre de recherche clinique Étienne-Le Bel du CHUS; 🇨🇦 Sherbrooke, Quebec, Canada