NCT04585204

Brief Summary

Both 50 gr OGTT-100 gr OGTT and 75 gr OGTT are used for detecting gestational diabetes mellitus. Two approaches are approved by obstetricians. With this study, we aim to compare the gestational diabetes mellitus detection rate of these different tests.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,282

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

October 1, 2020

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 14, 2020

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

August 15, 2024

Status Verified

July 1, 2024

Enrollment Period

4.2 years

First QC Date

October 9, 2020

Last Update Submit

August 14, 2024

Conditions

Gestational DiabetesGlucose Intolerance During Pregnancy

Outcome Measures

Primary Outcomes (1)

  • the difference of GDM detection rate of 50 gr- 100 gr OGTT and 75 gr OGTT

    to determine the ideal diagnostic test

    one year

Study Arms (2)

50 gr-100 gr OGTT

ACTIVE COMPARATOR

patients are tested firstly by 50 gr OGTT after that if necessary by 100 gr OGTT

Diagnostic Test: Oral glucose tolerance test

75 gr OGTT

ACTIVE COMPARATOR

patients are tested by 75 gr OGTT

Diagnostic Test: Oral glucose tolerance test

Interventions

Oral glucose tolerance testDIAGNOSTIC_TEST

Oral glucose tolerance test

50 gr-100 gr OGTT75 gr OGTT

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women

You may not qualify if:

  • Already diagnosed by diabetes mellitus
  • Multiple pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara City Hospital

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2020

First Posted

October 14, 2020

Study Start

October 1, 2020

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

August 15, 2024

Record last verified: 2024-07

Locations

TU(1)