Immediate Postpartum Glucose Tolerance Testing

NCT04199676 — Recruiting, 300 participants, MemorialCare Health System

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

RegistryNCT04199676
StatusRecruiting
Study typeObservational
Enrollment300 (Estimated)
SponsorMemorialCare Health System (Other)
ConditionsGestational Diabetes
InterventionsGlucose tolerance test (Diagnostic test)
Datesstart 2020-09-01, primary completion 2026-12-31 (estimated), completion 2026-12-31 (estimated), first posted 2019-12-16, last updated 2025-09-03
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Gestational Diabetes All trials of Glucose tolerance test

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
InterventionDiagnostic Test: Glucose tolerance test75g glucose tolerance test to be administered during postpartum hospitalization
  • Glucose tolerance test (Diagnostic test): Oral administration of a 75g glucose tolerance test during the postpartum hospitalization

+Outcome measures

Primary outcomes

  • Accuracy of immediate glucose tolerance testing [6-12 weeks postpartum]: Diagnostic accuracy between immediate postpartum glucose tolerance testing and gold standard testing

Secondary outcomes

  • Compliance with standard glucose tolerance testing [12 weeks postpartum]: Percentage of the cohort that comply with glucose tolerance testing at their postpartum visit
  • Transition to primary care [12 weeks postpartum]: Percentage of cohort that are appropriately referred to ongoing primary care

+Eligibility

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

+Locations (1)

FacilityCityCountryStatus
Long Beach Memorial Medical Center/Miller Children's and Women's HospitalLong Beach, CaliforniaUnited StatesRecruiting

+Investigators