Postpartum Screening of Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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Can we Screen Type 2 Diabetes on the 2nd Day After Delivery in Women Who Had Gestational Diabetes Mellitus?

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Procedure: oral glucose tolerance test 2 days post-partum


Participation Criteria
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Eligibility Criteria
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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.).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: postpartum screening<br>Oral glucose tolerance test 2 days post-partum | Procedure: oral glucose tolerance test 2 days post-partum<br>* Screening for type 2 diabetes after gestational diabetes mellitus.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of abnormal glucose tolerance | Oral glucose tolerance test | 12 weeks postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's satisfaction | Satisfaction questionnaire | 12 weeks post-partum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postpartum screening, type 2 diabetes