Abnormal Glucose Complicating PregnancyNCT07643987
Diagnosis of Gestational Diabetes Based on a 50-gram Glucose Challenge
An observational study of Abnormal Glucose Complicating Pregnancy, run by Methodist Health System at 1 site in United States.
Trial summary
The aim of this study is to determine a 1-hour glucose tolerance test (GTT) value at which the diagnosis of gestational diabetes can be made without undergoing a 3-hour test. 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
- Abnormal Glucose Complicating Pregnancy
- How many people
- 351 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2023to 29 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Pregnancies with multiple gestations, glucose tests prior to 24 weeks', or those with incomplete 50-gram or 100-gram screening records.
Who may be able to join
- Singleton pregnancies in which a 3-hour, 100-gram glucose test was completed and failed after 24-weeks' gestation.
Who cannot join
- Pregnancies with multiple gestations, glucose tests prior to 24 weeks', or those with incomplete 50-gram or 100-gram screening records.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Research Institute at Methodist Health System
Dallas, Texas, 75203
About this study
The aim of this study is to determine a 1-hour glucose tolerance test (GTT) value at which the diagnosis of gestational diabetes can be made without undergoing a 3-hour test.
Read the detailed description
Retrospective chart review to ascertain the 50-gram glucose screen values in pregnant women at Methodist Dallas Medical Center from April 2020 to April 2023 who failed the 100-gram glucose load.
- Conditions
- Abnormal Glucose Complicating Pregnancy
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if there is glucose value after the 50-gram oral GTT that can be used to diagnose gestational diabetes
The primary outcome will be the 50-gram glucose results for patients that were diagnosed with gestational diabetes by a 100-gram glucose challenge.
Measured: through study completion, up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start9 May 2023
- Primary completion29 Mar 2024
- Study completion29 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abnormal Glucose Complicating PregnancyStudies 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
- Retrospective
- Enrolment
- 351 participants (actual)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Margaret Warren, DO, MFM, Principal investigator, Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07643987
- Sponsor's protocol ID
- 017.MFM.2023.D
- Status last verified
- Apr 2024
- First submitted
- 8 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Gestational Diabetes Based on a 50-gram Glucose Challenge
- ClinicalTrials.gov ID
- NCT07643987
- Acronym / sponsor ID
- 017.MFM.2023.D
- Conditions
- Abnormal Glucose Complicating Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 351 participants (actual)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 9 May 2023 (actual)
- Primary completion
- 29 Mar 2024 (actual)
- Study completion
- 29 Mar 2024 (actual)
- First posted
- 12 Jun 2026 (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 aim of this study is to determine a 1-hour glucose tolerance test (GTT) value at which the diagnosis of gestational diabetes can be made without undergoing a 3-hour test.
Detailed description
Retrospective chart review to ascertain the 50-gram glucose screen values in pregnant women at Methodist Dallas Medical Center from April 2020 to April 2023 who failed the 100-gram glucose load.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnancies with multiple gestations, glucose tests prior to 24 weeks', or those with incomplete 50-gram or 100-gram screening records.
Key inclusion criteria (1 listed)
- Singleton pregnancies in which a 3-hour, 100-gram glucose test was completed and failed after 24-weeks' gestation.
Key exclusion criteria (1 listed)
- Pregnancies with multiple gestations, glucose tests prior to 24 weeks', or those with incomplete 50-gram or 100-gram screening records.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determine if there is glucose value after the 50-gram oral GTT that can be used to diagnose gestational diabetes
Time frame: through study completion, up to 18 months
The primary outcome will be the 50-gram glucose results for patients that were diagnosed with gestational diabetes by a 100-gram glucose challenge.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
Related trials for Abnormal Glucose Complicating Pregnancy
RecruitingObservational study
Cardiometabolic Disease and Substrate Metabolism
Preeclampsia, Gestational Diabetes Mellitus (GDM)
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. This study is not recruiting at the moment.
Margaret Warren, DO, MFM principal investigator
Physician
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 Abnormal Glucose Complicating Pregnancy, run by Methodist 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 12 Jun 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine if there is glucose value after the 50-gram oral GTT that can be used to diagnose gestational diabetes (time frame: through study completion, up to 18 months). 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 12 Jun 2026.