Immediate Postpartum Glucose Tolerance Testing

Gestational Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04199676
• Other study ID #: MHS 925-19
• Status: Recruiting
• Start date: September 1, 2020
• Est. completion date: July 1, 2025

Study information

• Verified date: April 2024
• Source: MemorialCare Health System
• Contact: Kenneth Chan, MD
• Phone: (562) 997-8510
• Email: kenneth_chan[@]mednax.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes

Intervention

Diagnostic Test:
• Glucose tolerance test
Oral administration of a 75g glucose tolerance test during the postpartum hospitalization

Locations

Country	Name	City	State
United States	Long Beach Memorial Medical Center/Miller Children's and Women's Hospital	Long Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
MemorialCare Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of immediate glucose tolerance testing	Diagnostic accuracy between immediate postpartum glucose tolerance testing and gold standard testing	6-12 weeks postpartum
Secondary	Compliance with standard glucose tolerance testing	Percentage of the cohort that comply with glucose tolerance testing at their postpartum visit	12 weeks postpartum
Secondary	Transition to primary care	Percentage of cohort that are appropriately referred to ongoing primary care	12 weeks postpartum