Early Screening for Gestational Diabetes Mellitus (DG2)

May 2, 2018 updated by: Jean-Luc Ardilouze, Université de Sherbrooke

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1442

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Centre de recherche clinique Etienne-Le Bel du CHUS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant Women

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
6-13 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6-13 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Sherbrooke

Collaborators

Canadian Diabetes Association

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2009

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

May 1, 2013

Study Registration Dates

First Submitted

December 3, 2009

First Submitted That Met QC Criteria

December 3, 2009

First Posted (ESTIMATE)

December 4, 2009

Study Record Updates

Last Update Posted (ACTUAL)

May 3, 2018

Last Update Submitted That Met QC Criteria

May 2, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-027
  • OG-3-08-2622-JA (OTHER_GRANT: Canadian Diabetes Association)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gestational Diabetes Mellitus

Clinical Trials on 50 g oral glucose challenge test - 75 g oral glucose tolerance test

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cyprus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe