Back to resultsSingle Non-fasting OGTT Versus Fasting OGTT for Screening of Hyperglycaemia in Pregnancy (HIP)
Primary Purpose
Diabetes in Pregnancy
Status
Unknown status
Phase
Phase 2
Locations
Pakistan
Study Type
Interventional
Intervention
Glucose
Sponsored by
About this trial
This is an interventional diagnostic trial for Diabetes in Pregnancy
Eligibility Criteria
Inclusion Criteria:
All pregnant women
Exclusion Criteria:
Known diabetic
Sites / Locations
- Isra University, Karachi Campus
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single
Arm Description
Outcomes
Primary Outcome Measures
Oral Glucose Tolerance
Measurement of Plasma Glucose after intake of 75 gram oral glucose
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04129190
Brief Title
Single Non-fasting OGTT Versus Fasting OGTT for Screening of Hyperglycaemia in Pregnancy (HIP)
Official Title
Single Non-fasting OGTT Versus Fasting OGTT for Screening of Hyperglycaemia in Pregnancy (HIP)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 15, 2019 (Anticipated)
Primary Completion Date
January 15, 2020 (Anticipated)
Study Completion Date
January 15, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isra University
4. Oversight
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
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes in Pregnancy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
225 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Glucose
Intervention Description
Oral Intake of Glucose
Primary Outcome Measure Information:
Title
Oral Glucose Tolerance
Description
Measurement of Plasma Glucose after intake of 75 gram oral glucose
Time Frame
2 hours
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All pregnant women
Exclusion Criteria:
Known diabetic
Facility Information:
Facility Name
Isra University, Karachi Campus
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74600
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Single Non-fasting OGTT Versus Fasting OGTT for Screening of Hyperglycaemia in Pregnancy (HIP)
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