Immediate Postpartum Glucose Tolerance Testing

NCT ID: NCT04199676

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2026-12-31

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.

Conditions

Gestational Diabetes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Intervention

75g glucose tolerance test to be administered during postpartum hospitalization

Glucose tolerance test

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Glucose tolerance test

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

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

MemorialCare Health System

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alice Sherman-Brown, MD

Role: PRINCIPAL_INVESTIGATOR

Magella Medical Group

Locations

Long Beach Memorial Medical Center/Miller Children's and Women's Hospital

Long Beach, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Alice Sherman-Bron, MD

Role: CONTACT

alicebrown092@gmail.com

(562) 997-8510

Facility Contacts

Alice Sherman-Brown, MD

Role: primary

alicebrown092@gmail.com

562-997-8510

Other Identifiers

925-19

Identifier Type: -

Identifier Source: org_study_id