Immediate Postpartum Glucose Tolerance Testing

Study Overview
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Brief Summary
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The objective of this study is to compare the accuracy of a 2hr glucose tolerance test administered during the postpartum hospitalization with the standard of care glucose tolerance testing (administered at 6 weeks postpartum). The primary hypothesis is that the glucose tolerance test administered in the postpartum period will be accurate and will improve compliance with postpartum testing for gestational diabetics.

Detailed Description
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Gestational diabetes affects approximately 5-10% of pregnancies and its prevalence continues to increase as rates of obesity and metabolic disease increase in reproductive age women. Women diagnosed with gestational diabetes carry an increased risk of developing type 2 diabetes later in life, even if their glucose tolerance initially normalizes following delivery. The gold standard assessment of glucose tolerance postpartum is a two hour glucose tolerance test (GTT) that is completed between six and twelve weeks' postpartum. Unfortunately, the compliance rate with this test is low, ranging from 30 - 50% by most reports. As a result, a large number of women with glucose intolerance are missed due to noncompliance with postpartum testing, thereby forfeiting the opportunity for diagnosis, treatment and prevention of longterm health consequences. The postpartum hospital stay provides a unique opportunity to increase compliance with glucose tolerance testing due to an increased rate of patient capture. However, it is unknown if administration of a glucose tolerance test in the immediate postpartum period would adequately identify women with persistent glucose intolerance. The current study aims to provide data towards the accuracy of an immediate postpartum GTT in a population of women with gestational diabetes and provide follow-up data on women with abnormal testing.

Official Title
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Immediate Postpartum Glucose Tolerance Testing Among Gestational Diabetics: A Comparison to the Gold Standard

Conditions
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Gestational Diabetes

Intervention / Treatment
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* Diagnostic Test: Glucose tolerance test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant or recently postpartum (postpartum day 0 or 1) ≥ 18 years of age Gestational age ≥34 weeks A1 or A2 gestational diabetes Exclusion Criteria: Medical exclusion from completing glucose tolerance testing Steroid administration within 10 days prior to enrollment Chronic steroid use

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intervention<br>75g glucose tolerance test to be administered during postpartum hospitalization | Diagnostic Test: Glucose tolerance test<br>* Oral administration of a 75g glucose tolerance test during the postpartum hospitalization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of immediate glucose tolerance testing | Diagnostic accuracy between immediate postpartum glucose tolerance testing and gold standard testing | 6-12 weeks postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance with standard glucose tolerance testing | Percentage of the cohort that comply with glucose tolerance testing at their postpartum visit | 12 weeks postpartum | 
| Transition to primary care | Percentage of cohort that are appropriately referred to ongoing primary care | 12 weeks postpartum |