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RecruitingNCT04199676

Immediate Postpartum Glucose Tolerance Testing

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

Status
Recruiting
Phase
Study type
Observational
Enrollment
300 (estimated)
Sponsor
MemorialCare Health System · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Accepted

Summary

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

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTGlucose tolerance testOral administration of a 75g glucose tolerance test during the postpartum hospitalization

Timeline

Start date
2020-09-01
Primary completion
2026-12-31
Completion
2026-12-31
First posted
2019-12-16
Last updated
2025-09-03

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04199676. Inclusion in this directory is not an endorsement.