Single Non-fasting OGTT Versus Fasting OGTT for Screening of Hyperglycaemia in Pregnancy (HIP)
Sponsor
Isra University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04129190
Collaborator
(none)
225
1
1
3
74.4
Study Details
Study Description
Brief Summary
With the increasing prevalence of diabetes in pregnancy it is necessary to design a simple, sensitive, cost effective method for screening of hyperglycaemia in pregnancy specially in resource constrained settings.
There is no universally agreed screening and diagnostic criteria to detect hyperglycemia in pregnancy. In present study, DIPSI (non-fasting OGTT) is compared with fasting oral glucose tolerance test (OGTT) to evaluate sensitivity and specificity of both methods in our population.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
225 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Single Non-fasting OGTT Versus Fasting OGTT for Screening of Hyperglycaemia in Pregnancy (HIP)
Anticipated Study Start Date
:
Oct 15, 2019
Anticipated Primary Completion Date
:
Jan 15, 2020
Anticipated Study Completion Date
:
Jan 15, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Single
|
Biological: Glucose
Oral Intake of Glucose
|
Outcome Measures
Primary Outcome Measures
- Oral Glucose Tolerance [2 hours]
Measurement of Plasma Glucose after intake of 75 gram oral glucose
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
All pregnant women
Exclusion Criteria:
Known diabetic
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Isra University, Karachi Campus | Karachi | Sindh | Pakistan | 74600 |
Sponsors and Collaborators
- Isra University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Dr shabeen,
Professor,
Isra University
ClinicalTrials.gov Identifier:
NCT04129190
Other Study ID Numbers:
- IsraU
First Posted:
Oct 16, 2019
Last Update Posted:
Oct 16, 2019
Last Verified:
Oct 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms: