Immediate Postpartum Glucose Tolerance Testing
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Glucose tolerance test.
- Who it may be relevant to
- Registry conditions: Gestational Diabetes. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Immediate Postpartum Glucose Tolerance Testing Among Gestational Diabetics: A Comparison to the Gold Standard
Overview
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.
Interventions
- Diagnostic test Glucose tolerance test
Oral administration of a 75g glucose tolerance test during the postpartum hospitalization
Primary outcome measures
- Accuracy of immediate glucose tolerance testing [Time frame: 6-12 weeks postpartum]
Secondary outcome measures (2)
- Compliance with standard glucose tolerance testing [Time frame: 12 weeks postpartum]
- Transition to primary care [Time frame: 12 weeks postpartum]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Long Beach Memorial Medical Center/Miller Children's and Women's Hospital — Long Beach
Identifiers
NCT: NCT04199676 · 925-19