Comparison of the Detection Rates of 50 Gr-100 gr OGTT and 75 gr OGTT That Require Medical Treatment of GDM
Sponsor
Ankara City Hospital Bilkent (Other)
Overall Status
Recruiting
CT.gov ID
NCT04585204
Collaborator
(none)
2,282
1
2
19
120.4
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
2282 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Comparison of the Detection Rates of 50 Gr-100 gr OGTT and 75 gr OGTT That Require Medical Treatment of GDM
Actual Study Start Date
:
Oct 1, 2020
Anticipated Primary Completion Date
:
Apr 1, 2022
Anticipated Study Completion Date
:
May 1, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 50 gr-100 gr OGTT patients are tested firstly by 50 gr OGTT after that if necessary by 100 gr OGTT |
Diagnostic Test: Oral glucose tolerance test
Oral glucose tolerance test
|
| Active Comparator: 75 gr OGTT patients are tested by 75 gr OGTT |
Diagnostic Test: Oral glucose tolerance test
Oral glucose tolerance test
|
Outcome Measures
Primary Outcome Measures
- the difference of GDM detection rate of 50 gr- 100 gr OGTT and 75 gr OGTT [one year]
to determine the ideal diagnostic test
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- Pregnant women
Exclusion Criteria:
-
Already diagnosed by diabetes mellitus
-
Multiple pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ankara City Hospital | Ankara | Turkey |
Sponsors and Collaborators
- Ankara City Hospital Bilkent
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Ankara City Hospital Bilkent
ClinicalTrials.gov Identifier:
NCT04585204
Other Study ID Numbers:
- E1-20-800
First Posted:
Oct 14, 2020
Last Update Posted:
Feb 21, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: