Diagnosis of Gestational Diabetes Based on a 50-gram Gluc... | NCT07643987

Studies
Diagnosis of Gestational Diabetes Based on a 50-gram Glucose Challenge

NCT07643987

Sponsor

Methodist Health System

Status

Completed

Last Update Posted

Jun 12, 2026Actual

Enrollment

351Actual

Phase

Not provided

Conditions

Abnormal Glucose Complicating Pregnancy

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 9, 2023Actual

Primary Completion Date

Mar 29, 2024Actual

Completion Date

Mar 29, 2024Actual

First Submitted Date

Jun 8, 2026

First Submission Date that Met QC Criteria

Jun 8, 2026

First Posted Date

Jun 12, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 8, 2026

Last Update Posted Date

Jun 12, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

351Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	through study completion, up to 18 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Singleton pregnancies in which a 3-hour, 100-gram glucose test was completed and failed after 24-weeks' gestation.

Exclusion Criteria:

Pregnancies with multiple gestations, glucose tests prior to 24 weeks', or those with incomplete 50-gram or 100-gram screening records.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Pregnancies with multiple gestations, glucose tests prior to 24 weeks', or those with incomplete 50-gram or 100-gram screening records.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Margaret Warren, DO, MFM	Physician	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Research Institute at Methodist Health System		Dallas	Texas	75203	United States