Postpartum Screening of Type 2 Diabetes (Tot ou tard)
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|ClinicalTrials.gov Identifier: NCT01869608|
Recruitment Status : Active, not recruiting
First Posted : June 5, 2013
Last Update Posted : May 3, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Procedure: oral glucose tolerance test 2 days post-partum||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||145 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Can we Screen Type 2 Diabetes on the 2nd Day After Delivery in Women Who Had Gestational Diabetes Mellitus?|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||December 2018|
Experimental: postpartum screening
Oral glucose tolerance test 2 days post-partum
Procedure: oral glucose tolerance test 2 days post-partum
Screening for type 2 diabetes after gestational diabetes mellitus.
- Diagnosis of abnormal glucose tolerance [ Time Frame: 12 weeks postpartum ]Oral glucose tolerance test
- Patient's satisfaction [ Time Frame: 12 weeks post-partum ]Satisfaction questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01869608
|Clinical Research Center Étienne-Le Bel of the Sherbrooke University Hospital|
|Sherbrooke, Quebec, Canada, J1H 5N4|
|Principal Investigator:||Jean-Luc Ardilouze, MD, PhD||Clinical Research Center Étienne-Le Bel of the Sherbrooke University Hospital|