Immediate Postpartum Glucose Tolerance Testing

Recruiting

• Conditions: Gestational Diabetes

• Registration Number: NCT04199676
• Lead Sponsor: MemorialCare Health System

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.

Study Timeline

• Study First Submitted: 2019-12-12
• Study First Submitted QC: 2019-12-12
• Study First Posted: 2019-12-16
• Study Start: 2020-09-01
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-27
• Last Update Posted: 2025-07-02
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accuracy of immediate glucose tolerance testing	6-12 weeks postpartum	Diagnostic accuracy between immediate postpartum glucose tolerance testing and gold standard testing

Secondary Outcome Measures

Name	Time	Method
Transition to primary care	12 weeks postpartum	Percentage of cohort that are appropriately referred to ongoing primary care
Compliance with standard glucose tolerance testing	12 weeks postpartum	Percentage of the cohort that comply with glucose tolerance testing at their postpartum visit

Trial Locations

Locations (1)

Long Beach Memorial Medical Center/Miller Children's and Women's Hospital; 🇺🇸 Long Beach, California, United States