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Single 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
Isra University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diabetes in Pregnancy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

First Posted
October 15, 2019
Last Updated
October 15, 2019
Sponsor
Isra University
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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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