Early Screening for Gestational Diabetes Mellitus (DG2)

This study has been completed.
Sponsor:
Collaborator:
Canadian Diabetes Association
Information provided by (Responsible Party):
Jean-Luc Ardilouze, Universitaire de Sherbrooke
ClinicalTrials.gov Identifier:
NCT01026675
First received: December 3, 2009
Last updated: May 10, 2013
Last verified: May 2013
  Purpose

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 Intervention
Gestational Diabetes Mellitus
Procedure: 50 g oral glucose challenge test - 75 g oral glucose tolerance test

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Screening for Gestational Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Université de Sherbrooke:

Primary Outcome Measures:
  • oral glucose challenge test plasma glucose value [ Time Frame: 6-13 weeks ] [ Designated as safety issue: No ]
    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:
  • oral glucose challenge test plasma glucose cut-off value [ Time Frame: 6-13 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 1442
Study Start Date: April 2009
Study Completion Date: May 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Pregnant Women

Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01026675

Locations
Canada, Quebec
Centre de recherche clinique Étienne-Le Bel du CHUS
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Université de Sherbrooke
Canadian Diabetes Association
Investigators
Principal Investigator: Jean-Luc Ardilouze, MD, PhD Université de Sherbrooke
  More Information

No publications provided

Responsible Party: Jean-Luc Ardilouze, Endocrinologist, researcher, Universitaire de Sherbrooke
ClinicalTrials.gov Identifier: NCT01026675     History of Changes
Other Study ID Numbers: 07-027, OG-3-08-2622-JA
Study First Received: December 3, 2009
Last Updated: May 10, 2013
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications

ClinicalTrials.gov processed this record on July 31, 2014