Immediate Postpartum Glucose Tolerance Testing Among Gestational Diabetics: A Comparison to the Gold Standard
| Registry | NCT04199676 |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Enrollment | 300 (Estimated) |
| Sponsor | MemorialCare Health System (Other) |
| Conditions | Gestational Diabetes |
| Interventions | Glucose tolerance test (Diagnostic test) |
| Dates | start 2020-09-01, primary completion 2026-12-31 (estimated), completion 2026-12-31 (estimated), first posted 2019-12-16, last updated 2025-09-03 |
| Locations | 1 site in United States |
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All trials for Gestational Diabetes All trials of Glucose tolerance test
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Intervention | Diagnostic Test: Glucose tolerance test | 75g glucose tolerance test to be administered during postpartum hospitalization |
Sex: Female, ages: 18 Years to any, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| Long Beach Memorial Medical Center/Miller Children's and Women's Hospital | Long Beach, California | United States | Recruiting |