NCT07643987

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
351

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 9, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2024

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

June 8, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 12, 2026

Completed
Last Updated

June 12, 2026

Status Verified

April 1, 2024

Enrollment Period

11 months

First QC Date

June 8, 2026

Last Update Submit

June 8, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Institute at Methodist Health System

Dallas, Texas, 75203, United States

Location

Study Officials

  • Margaret Warren, DO, MFM

    Physician

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2026

First Posted

June 12, 2026

Study Start

May 9, 2023

Primary Completion

March 29, 2024

Study Completion

March 29, 2024

Last Updated

June 12, 2026

Record last verified: 2024-04

Locations