Evaluating for Type-2 Diabetes in the Very Early Postpartum Period

Study Overview
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Brief Summary
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Pregnancy-associated diabetes, known as gestational diabetes mellitus (GDM), is associated with an increased lifetime risk of developing diabetes mellitus (DM) or pre-diabetes. Up to 30% of women with GDM will continue have abnormal blood glucose tests 6 or more weeks after delivery. Early diagnosis and treatment of continued impaired glucose metabolism or DM is essential because serious health problems can result. Current guidelines recommend a 75-gram, 2-hour glucose tolerance test (GTT) 6 or more weeks after delivery for women diagnosed with GDM in order to identify those with continued DM or impaired glucose metabolism. However, approximately half of these women do not get glucose testing after delivery. The ability to test women while they are still hospitalized after having a baby could greatly increase diagnosis, care and treatment of women with abnormal glucose metabolism. Our objective is to determine if a 75-gram, 2-hour GTT administered to women with GDM two to four days after delivery can identify those who will have an abnormal GTT at 6-12 weeks after delivery.

Detailed Description
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This will be a prospective cohort study conducted at Winthrop-University Hospital. Women 18 years old or older who delivered a child or fetus within the previous 4 days at either hospital who also were diagnosed with GDM during the pregnancy will be eligible for participation. Women will be excluded if they have issues that would interfere with administration of a GTT, are unable /unwilling to provide informed consent, or cannot follow up. Anticipated enrollment will be 250 women at each study site. While still hospitalized two to four days postpartum, subjects will undergo a 75-gram, 2-hour GTT and have blood tested for hemoglobin A1c and glucose levels. They will be reminded to do the recommended GTT 6-12 weeks after delivery. Maternal, neonatal, and obstetric characteristics will be collected, including the any GTT results. The results of the in-hospital GTT will be compared to the result of the GTT taken 6-12 weeks postpartum and tested for correlation.

Official Title
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Evaluating for Type-2 Diabetes in the Very Early Post-Partum Period

Conditions
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Diabetes Mellitus, Diabetes, Gestational, Prediabetic State, Glucose Metabolism Disorders

Intervention / Treatment
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* Other: Inpatient Postpartum GTT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women 18 years old or older Delivered a child or fetus within the previous 4 days Diagnosed with gestational diabetes during the pregnancy Exclusion Criteria: Unable or unwilling to provide informed consent for the study Unable to undergo or complete a 2-hour oral glucose tolerance test 2-4 days postpartum Unable or unwilling to have study follow up.

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Inpatient Postpartum GTT<br>Women with gestational diabetes will undergo a 75 gram, 2 hour, oral glucose tolerance test 2-4 days postpartum prior to hospital discharge, in addition to undergoing the standard of care, outpatient glucose tolerance test performed 6-12 weeks postpartum | Other: Inpatient Postpartum GTT<br>* Women with gestational diabetes will undergo a 75 gram, 2 hour, oral glucose tolerance test 2-4 days postpartum prior to hospital discharge, in addition to undergoing the standard of care, outpatient glucose tolerance test performed 6-12 weeks postpartum<br>* Other names: OGTT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Result of an early postpartum 75-gram oral glucose tolerance test (GTT) result | The GTT result obtained 2-4 days postpartum will be compared to the GTT result obtained 6-12 weeks postpartum using the McNemar test for paired proportions. | 2-4 days postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Result of a postpartum 75-gram oral glucose tolerance test (GTT) | The GTT result obtained 2-4 days postpartum will be compared to the GTT result obtained 6-12 weeks postpartum using the McNemar test for paired proportions. | 6 weeks-6 months postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gestational diabetes, Postpartum glucose testing, Impaired glucose metabolism, Diabetes mellitus