Single Non-fasting OGTT Versus Fasting OGTT for Screening of Hyperglycaemia in Pregnancy (HIP)

October 15, 2019 updated by: Dr shabeen, Isra University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

225

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 74600
        • Isra University, Karachi Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

All pregnant women

Exclusion Criteria:

Known diabetic

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single
Biological: Glucose
Oral Intake of Glucose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral Glucose Tolerance
Time Frame: 2 hours
Measurement of Plasma Glucose after intake of 75 gram oral glucose
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Isra University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 15, 2019

Primary Completion (Anticipated)

January 15, 2020

Study Completion (Anticipated)

January 15, 2020

Study Registration Dates

First Submitted

October 15, 2019

First Submitted That Met QC Criteria

October 15, 2019

First Posted (Actual)

October 16, 2019

Study Record Updates

Last Update Posted (Actual)

October 16, 2019

Last Update Submitted That Met QC Criteria

October 15, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IsraU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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