Early Screening for Gestational Diabetes Mellitus

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Centre de recherche clinique Étienne-Le Bel du CHUS

Sherbrooke, Quebec, J1H 5N4, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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).

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Collaborators

Canadian Diabetes Association

Registry information

Acronym: DG2

Important dates

Study start: 2009
Primary completion: 2012
Study completion: 2013
First posted: Dec 4, 2009
Registry last updated: May 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed