Immediate Postpartum Glucose Tolerance Testing

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

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.

Study Overview

• Status: Recruiting
• Conditions: Gestational Diabetes
• Intervention / Treatment: Diagnostic test: Glucose tolerance test

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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Kenneth Chan, MD; Phone Number: (562) 997-8510; Email: kenneth_chan@mednax.com
• Study Contact Backup: Name: Ashten Waks, MD; Phone Number: (949) 702-0704; Email: awaks@hs.uci.edu

Study Locations

• United States
  • California
    • Long Beach, California, United States, 90806
      • Recruiting
      • Long Beach Memorial Medical Center/Miller Children's and Women's Hospital
      • Contact: Kenneth Chan, MD; Email: KChan@memorialcare.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intervention; 75g glucose tolerance test to be administered during postpartum hospitalization	Diagnostic test: Glucose tolerance test; Oral administration of a 75g glucose tolerance test during the postpartum hospitalization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of immediate glucose tolerance testing	Diagnostic accuracy between immediate postpartum glucose tolerance testing and gold standard testing	6-12 weeks postpartum

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: MemorialCare Health System
• Investigators: Principal Investigator: Kenneth Chan, MD, Magella Medical Group

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: December 12, 2019
• First Submitted That Met QC Criteria: December 12, 2019
• First Posted (Actual): December 16, 2019

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 24, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Pregnancy Complications; Diabetes, Gestational
• Other Study ID Numbers: MHS 925-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No