Postpartum Screening of Type 2 Diabetes (Tot ou tard)
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
oral glucose tolerance test 2 days post-partum
Sponsored by
About this trial
This is an interventional diagnostic trial for Type 2 Diabetes focused on measuring postpartum screening, type 2 diabetes
Eligibility Criteria
Inclusion Criteria:
- Women aged between 18 and 45 years;
- Having a positive diagnosis of gestational diabetes mellitus (IADPSG criteria);
- Treated with diet or insulin;
- Have given birth to a child at term; gestational age > 37 weeks;
- Have been followed during her pregnancy by a physician who delivers in CHUS;
- Have signed the consent form.
Exclusion Criteria:
- History of glucose intolerance or diabetes before the pregnancy;
Have presented another obstetrical pathology during the pregnancy;
- Severe gestational high blood pressure with proteinuria;
- Delayed intrauterine development syndrome;
- Pregnancy with more than a foetus;
- Drug addiction;
- Had complications during the delivery such as:
- Moderate to severe postpartum bleeding;
- Surgery in postpartum (curettage, hysterectomy, etc.).
Sites / Locations
- Clinical Research Center Étienne-Le Bel of the Sherbrooke University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
postpartum screening
Arm Description
Oral glucose tolerance test 2 days post-partum
Outcomes
Primary Outcome Measures
Diagnosis of abnormal glucose tolerance
Oral glucose tolerance test
Secondary Outcome Measures
Patient's satisfaction
Satisfaction questionnaire
Full Information
NCT ID
NCT01869608
First Posted
May 15, 2013
Last Updated
April 29, 2019
Sponsor
Université de Sherbrooke
Collaborators
The Lawson Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01869608
Brief Title
Postpartum Screening of Type 2 Diabetes
Acronym
Tot ou tard
Official Title
Can we Screen Type 2 Diabetes on the 2nd Day After Delivery in Women Who Had Gestational Diabetes Mellitus?
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
April 2014 (Actual)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Sherbrooke
Collaborators
The Lawson Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Gestational diabetes mellitus (GDM) complicates 5 to 30 % of pregnancies. GDM is defined as hyperglycemia with onset or first recognition during pregnancy. Because it is a forerunner of type 2 diabetes mellitus (T2DM), professional associations recommend T2DM postpartum screening (T2DM-pPS) at 6 weeks/6 months post delivery, using a 75g oral glucose tolerance test (OGTT).
However, less than a quarter of these women are screened. This recommendation has failed for multiple reasons; the most important being that busy new mothers must deal with the major inconveniences of returning to a sampling center for a 2h testing session, bringing baby along or paying for a sitter, transportation, parking… A mother-friendly solution is direly needed.
The investigators hypothesize that, in these women, results of an OGTT performed after delivery on the last day of their hospital stay (OGTT-1) will predict results of the recommended OGTT (OGTT-2) at 6 weeks/6 months postpartum.
The main aim of our project is to determine the optimal cut-off value for the 2h glucose result during OGTT-1 in order to predict abnormal glucose tolerance status at OGTT-2 (the gold standard), in the same woman.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
postpartum screening, type 2 diabetes
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
121 (Actual)
8. Arms, Groups, and Interventions
Arm Title
postpartum screening
Arm Type
Experimental
Arm Description
Oral glucose tolerance test 2 days post-partum
Intervention Type
Procedure
Intervention Name(s)
oral glucose tolerance test 2 days post-partum
Intervention Description
Screening for type 2 diabetes after gestational diabetes mellitus.
Primary Outcome Measure Information:
Title
Diagnosis of abnormal glucose tolerance
Description
Oral glucose tolerance test
Time Frame
12 weeks postpartum
Secondary Outcome Measure Information:
Title
Patient's satisfaction
Description
Satisfaction questionnaire
Time Frame
12 weeks post-partum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women aged between 18 and 45 years;
Having a positive diagnosis of gestational diabetes mellitus (IADPSG criteria);
Treated with diet or insulin;
Have given birth to a child at term; gestational age > 37 weeks;
Have been followed during her pregnancy by a physician who delivers in CHUS;
Have signed the consent form.
Exclusion Criteria:
History of glucose intolerance or diabetes before the pregnancy;
Have presented another obstetrical pathology during the pregnancy;
Severe gestational high blood pressure with proteinuria;
Delayed intrauterine development syndrome;
Pregnancy with more than a foetus;
Drug addiction;
Had complications during the delivery such as:
Moderate to severe postpartum bleeding;
Surgery in postpartum (curettage, hysterectomy, etc.).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Luc Ardilouze, MD, PhD
Organizational Affiliation
Clinical Research Center Étienne-Le Bel of the Sherbrooke University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Research Center Étienne-Le Bel of the Sherbrooke University Hospital
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Postpartum Screening of Type 2 Diabetes
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