Immediate Postpartum Glucose Tolerance Testing

NCT04199676 | Recruiting

• 1 other identifier: 925-19
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes

Outcome Measures

Primary Outcomes (1)

• Accuracy of immediate glucose tolerance testing

  Diagnostic accuracy between immediate postpartum glucose tolerance testing and gold standard testing

  6-12 weeks postpartum

Secondary Outcomes (2)

• Compliance with standard glucose tolerance testing

  12 weeks postpartum

• Transition to primary care

  12 weeks postpartum

Study Arms (1)

Intervention

75g glucose tolerance test to be administered during postpartum hospitalization

Diagnostic Test: Glucose tolerance test

Interventions

Glucose tolerance test DIAGNOSTIC_TEST

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All individual diagnosed with gestational diabetes will be approached following admission to labor and delivery and invited to participate.

You may qualify if:

• Pregnant or recently postpartum (postpartum day 0 or 1)
• ≥ 18 years of age
• Gestational age ≥34 weeks
• A1 or A2 gestational diabetes

You may not qualify if:

• Steroid administration within 10 days prior to enrollment
• Chronic steroid use

Sponsors & Collaborators

• MemorialCare Health System: lead

Study Sites (1)

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

Long Beach, California, 90806, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood specimens will be obtained as part of the glucose tolerance testing

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques

Study Officials

• Alice Sherman-Brown, MD

  Magella Medical Group

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alice Sherman-Bron, MD

CONTACT

(562) 997-8510; alicebrown092@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: December 16, 2019
• Study Start: September 1, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-09

Locations

US (1)