Early Screening for Gestational Diabetes Mellitus

Gestational Diabetes Mellitus Clinical Trial

— DG2  

Official title:

Early Screening for Gestational Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01026675
• Other study ID #: 07-027
• Secondary ID: OG-3-08-2622-JA
• Status: Completed
• Start date: April 2009
• Est. completion date: May 2013

Study information

• Verified date: May 2018
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1442
• Est. completion date: May 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
Canada	Centre de recherche clinique Étienne-Le Bel du CHUS	Sherbrooke	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Université de Sherbrooke	Canadian Diabetes Association

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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