Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00295659
Status:
COMPLETED
Last Update Posted:
2006-10-18
First Post:
2006-02-22
Brief Title:
An RCT to Evaluate Incidence Cost and Clinical Outcomes Using 75 vs 100g Screening Methods for Gestational Diabetes
Sponsor:
Canadian Diabetes Association
Organization:
Canadian Diabetes Association
Study Overview
Official Title:
What is the Optimal Method for Screening and Diagnosis of Gestational Diabetes An RCT to Evaluate Incidence Cost-Effectiveness and Clinical Outcomes Using Three Methods
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Diabetes in pregnancy or gestational diabetes GDM is a condition that if left untreated may lead to complications for the mother and her baby It is still not known which is the best method to diagnosis GDM The goal of this study is to compare three well-accepted methods for diagnosis of GDM using either 75 g or 100 g in the glucose tolerance test and determine which method is the easiest and least expensive to use in relation to the reference method used over the last 20 years The goal is to see if they can equally predict the healthy outcome of the pregnant mother and her newborn
Detailed Description:
Title What is the optimal method for screening and diagnosis of gestational diabetes A randomised clinical trial to evaluate incidence of GDM cost-effectiveness and clinical outcomes using three methods
Objectives 1 To evaluate the incidence and cost-effectiveness of screening and diagnosis of GDM by comparing three different methods 2 To evaluate the following by each method population characteristics gestational age at screening diagnosis and initiation of treatment and maternal and neonatal outcomes
Rationale There is no consensus on the best method to identify cases of GDM numerous screening and diagnostic procedures are employed worldwide Recently the Canadian Guidelines recommended a new set of values based on normative data yet these data have not been validated against a large population and compared with diagnostic rates and outcomes head to head against the long accepted values of OSullivan and Mahan In addition the question of cost in a Canadian healthcare setting has never been addressed yet it is a significant societal concern The results of this study would help clarify these issues using evidence-based methodology
Outline Pregnant women referred as outpatients for glucose testing for GDM will be given a study information sheet by obstetrics staff At the time of booking the test they will be reminded of the study and to arrive fasting On the day of glucose testing the research assistant will invite patients to participate obtain consent and perform randomisation into one three groups
1 50g screen 100g 3h GTT 2 50g screen 75g 2h GTT or 3 75g 2h GTT During the glucose test study participants will also be asked information on health and costs incurred for the process of glucose testing If the screen or GTT needs to be repeated at some time during the pregnancy patients will remain in the same study arm as originally assigned Interpretation of results by patients caregivers and referral to the diabetes clinic as needed will continue as usual Data will be analysed using appropriate bivariate and multivariate methods for GDM incidence direct and indirect costs of glucose testing and maternal and infant outcomes
Significance to DM This study will evaluate the diagnostic efficacy cost-effectiveness and clinical outcomes of three methods A one-step procedure may be better tolerated compared to a two-step approach with respect to number of visits amount of drink and length of testing Furthermore diagnosis by a single test may avoid unnecessary delay in initiation of therapy and still identify those patients at risk for type 2 DM
Objectives 1 To evaluate the incidence and cost-effectiveness of screening and diagnosis of GDM by comparing three different methods 2 To evaluate the following by each method population characteristics gestational age at screening diagnosis and initiation of treatment and maternal and neonatal outcomes
Rationale There is no consensus on the best method to identify cases of GDM numerous screening and diagnostic procedures are employed worldwide Recently the Canadian Guidelines recommended a new set of values based on normative data yet these data have not been validated against a large population and compared with diagnostic rates and outcomes head to head against the long accepted values of OSullivan and Mahan In addition the question of cost in a Canadian healthcare setting has never been addressed yet it is a significant societal concern The results of this study would help clarify these issues using evidence-based methodology
Outline Pregnant women referred as outpatients for glucose testing for GDM will be given a study information sheet by obstetrics staff At the time of booking the test they will be reminded of the study and to arrive fasting On the day of glucose testing the research assistant will invite patients to participate obtain consent and perform randomisation into one three groups
1 50g screen 100g 3h GTT 2 50g screen 75g 2h GTT or 3 75g 2h GTT During the glucose test study participants will also be asked information on health and costs incurred for the process of glucose testing If the screen or GTT needs to be repeated at some time during the pregnancy patients will remain in the same study arm as originally assigned Interpretation of results by patients caregivers and referral to the diabetes clinic as needed will continue as usual Data will be analysed using appropriate bivariate and multivariate methods for GDM incidence direct and indirect costs of glucose testing and maternal and infant outcomes
Significance to DM This study will evaluate the diagnostic efficacy cost-effectiveness and clinical outcomes of three methods A one-step procedure may be better tolerated compared to a two-step approach with respect to number of visits amount of drink and length of testing Furthermore diagnosis by a single test may avoid unnecessary delay in initiation of therapy and still identify those patients at risk for type 2 DM
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None