Clinical trial NCT04199676: Immediate Postpartum Glucose Tolerance Testing
Official title: Immediate Postpartum Glucose Tolerance Testing Among Gestational Diabetics: A Comparison to the Gold Standard
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gestational Diabetes
Lead sponsor: MemorialCare Health System
Sponsor class: OTHER
First posted: 2019-12-16
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Accuracy of immediate glucose tolerance testing
timeFrame: 6-12 weeks postpartum
Secondary outcomes:
measure: Compliance with standard glucose tolerance testing
timeFrame: 12 weeks postpartum
measure: Transition to primary care
timeFrame: 12 weeks postpartum
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Long Beach Memorial Medical Center/Miller Children's and Women's Hospital
state: California
Study officials:
affiliation: Magella Medical Group
name: Kenneth Chan, MD
role: PRINCIPAL_INVESTIGATOR
References: