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NCT Number: NCT04199676

Immediate Postpartum Glucose Tolerance Testing

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

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

Long Beach, California, 90806, United States

Location status: Recruiting

Location contact

Alice Sherman-Brown, MD

CONTACT

[email protected]

562-997-8510

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glucose tolerance test

Diagnostic Test

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

Primary outcomes

  1. Accuracy of immediate glucose tolerance testing

    Time frame: 6-12 weeks postpartum

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

Secondary outcomes

  1. Compliance with standard glucose tolerance testing

    Time frame: 12 weeks postpartum

    Percentage of the cohort that comply with glucose tolerance testing at their postpartum visit

  2. Transition to primary care

    Time frame: 12 weeks postpartum

    Percentage of cohort that are appropriately referred to ongoing primary care

Study contacts

Contact information is provided by the study sponsor or research team.

Alice Sherman-Bron, MD

CONTACT

[email protected]

(562) 997-8510

Sponsors and collaborators

Lead sponsor

MemorialCare Health System

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Dec 16, 2019
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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