Early Screening for Gestational Diabetes Mellitus

NCT01026675 | Completed

• 2 other identifiers: 07-027OG-3-08-2622-JA
• Study Type: observational
• Target: 1,442
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• oral glucose challenge test plasma glucose cut-off value

  6-13 weeks

Study Arms (1)

Pregnant women 6-13 weeks

Procedure: 50 g oral glucose challenge test - 75 g oral glucose tolerance test

Interventions

50 g oral glucose challenge test - 75 g oral glucose tolerance test PROCEDURE

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.

Pregnant women 6-13 weeks

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant Women

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Canadian Diabetes Association: collaborator

Study Sites (1)

Centre de recherche clinique Étienne-Le Bel du CHUS

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques

Study Officials

• Jean-Luc Ardilouze, MD, PhD

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Endocrinologist, researcher

Study Record Dates

• First Submitted: December 3, 2009
• First Posted: December 4, 2009
• Study Start: April 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: May 1, 2013
• Last Updated: May 3, 2018

Record last verified: 2018-05

Locations

CA (1)