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Immediate Postpartum Glucose Tolerance Testing

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04199676
Enrollment
300
Registered
2019-12-16
Start date
2020-09-01
Completion date
2026-12-31
Last updated
2025-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes

Brief 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.

Interventions

DIAGNOSTIC_TESTGlucose tolerance test

Oral administration of a 75g glucose tolerance test during the postpartum hospitalization

Sponsors

MemorialCare Health System
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of immediate glucose tolerance testing6-12 weeks postpartumDiagnostic accuracy between immediate postpartum glucose tolerance testing and gold standard testing

Secondary

MeasureTime frameDescription
Compliance with standard glucose tolerance testing12 weeks postpartumPercentage of the cohort that comply with glucose tolerance testing at their postpartum visit
Transition to primary care12 weeks postpartumPercentage of cohort that are appropriately referred to ongoing primary care

Countries

United States

Contacts

Primary ContactAlice Sherman-Bron, MD
alicebrown092@gmail.com(562) 997-8510

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026