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NCT04129190 Clinical Trial

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

Diabetes in Pregnancy Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04129190
Other study ID # IsraU
Secondary ID
Status Enrolling by invitation
Phase Phase 2
First received
Last updated
Start date October 15, 2019
Est. completion date January 15, 2020

Study information
Verified date October 2019
Source Isra University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 225
Est. completion date January 15, 2020
Est. primary completion date January 15, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

All pregnant women

Exclusion Criteria:

Known diabetic

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Glucose
Oral Intake of Glucose

Locations
Country Name City State
Pakistan Isra University, Karachi Campus Karachi Sindh

Sponsors (1)
Lead Sponsor Collaborator
Isra University

Country where clinical trial is conducted

Pakistan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Oral Glucose Tolerance Measurement of Plasma Glucose after intake of 75 gram oral glucose 2 hours
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