Gestational DiabetesNCT04199676
Immediate Postpartum Glucose Tolerance Testing
An observational study of Gestational Diabetes, run by MemorialCare Health System at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Glucose tolerance test
- Type of treatment
- Pill or oral medicine
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: All individual diagnosed with gestational diabetes will be approached following admission to labor and delivery and invited to participate.
Who may be able to join
- Pregnant or recently postpartum (postpartum day 0 or 1)
- ≥ 18 years of age
- Gestational age ≥34 weeks
- A1 or A2 gestational diabetes
Who cannot join
- Medical exclusion from completing glucose tolerance testing
- Steroid administration within 10 days prior to enrollment
- Chronic steroid use
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Long Beach Memorial Medical Center/Miller Children's and Women's Hospital
Long Beach, California, 90806
Alice Sherman-Brown, MD, 562-997-8510, alicebrown092@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Gestational Diabetes
- Being tested
- Glucose tolerance test
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose tolerance testDiagnostic test
Oral administration of a 75g glucose tolerance test during the postpartum hospitalization
| Study group | Role | What they receive |
|---|---|---|
| Intervention | 75g glucose tolerance test to be administered during postpartum hospitalization Receives: Diagnostic Test: Glucose tolerance test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of immediate glucose tolerance testing
Diagnostic accuracy between immediate postpartum glucose tolerance testing and gold standard testing
Measured: 6-12 weeks postpartum
Secondary outcomes (2)
Compliance with standard glucose tolerance testing
Percentage of the cohort that comply with glucose tolerance testing at their postpartum visit
Measured: 12 weeks postpartum
Transition to primary care
Percentage of cohort that are appropriately referred to ongoing primary care
Measured: 12 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start1 Sep 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MemorialCare Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alice Sherman-Brown, MD, Principal investigator, Magella Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04199676
- Sponsor's protocol ID
- 925-19
- Status last verified
- Sep 2025
- First submitted
- 12 Dec 2019
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Postpartum Glucose Tolerance Testing Among Gestational Diabetics: A Comparison to the Gold Standard
- ClinicalTrials.gov ID
- NCT04199676
- Acronym / sponsor ID
- 925-19
- Conditions
- Gestational Diabetes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- MemorialCare Health SystemUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Diagnostic Test: Glucose tolerance test75g glucose tolerance test to be administered during postpartum hospitalization |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All individual diagnosed with gestational diabetes will be approached following admission to labor and delivery and invited to participate.
Key inclusion criteria (4 listed)
- Pregnant or recently postpartum (postpartum day 0 or 1)
- ≥ 18 years of age
- Gestational age ≥34 weeks
- A1 or A2 gestational diabetes
Key exclusion criteria (3 listed)
- Medical exclusion from completing glucose tolerance testing
- Steroid administration within 10 days prior to enrollment
- Chronic steroid use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucose tolerance testOral administration of a 75g glucose tolerance test during the postpartum hospitalization | Diagnostic test | Intervention |
Primary outcome
Accuracy of immediate glucose tolerance testing
Time frame: 6-12 weeks postpartum
Diagnostic accuracy between immediate postpartum glucose tolerance testing and gold standard testing
2 secondary outcomes
Compliance with standard glucose tolerance testing
Time frame: 12 weeks postpartum
Transition to primary care
Time frame: 12 weeks postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alice Sherman-Brown, MD principal investigator
Magella Medical Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes, run by MemorialCare Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alice Sherman-Bron, MD ((562) 997-8510, alicebrown092@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of immediate glucose tolerance testing (time frame: 6-12 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025; AzTrials last refreshed its copy on 2 Nov 2026.