Postpartum Screening of Type 2 Diabetes
This trial is active, not recruiting.
|Condition||type 2 diabetes|
|Treatment||oral glucose tolerance test 2 days post-partum|
|Sponsor||Université de Sherbrooke|
|Collaborator||The Lawson Foundation|
|Start date||April 2014|
|End date||December 2014|
|Trial size||145 participants|
|Trial identifier||NCT01869608, 13-005|
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.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
Oral glucose tolerance test 2 days post-partum
Diagnosis of abnormal glucose tolerance
time frame: 12 weeks postpartum
time frame: 12 weeks post-partum
Female participants from 18 years up to 45 years old.
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.).
|Official title||Can we Screen Type 2 Diabetes on the 2nd Day After Delivery in Women Who Had Gestational Diabetes Mellitus?|
|Principal investigator||Jean-Luc Ardilouze, MD, PhD|
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