NCT04129190

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
225

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2019

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

October 15, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 16, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2020

Completed
Last Updated

October 16, 2019

Status Verified

October 1, 2019

Enrollment Period

3 months

First QC Date

October 15, 2019

Last Update Submit

October 15, 2019

Conditions

Diabetes in Pregnancy

Outcome Measures

Primary Outcomes (1)

  • Oral Glucose Tolerance

    Measurement of Plasma Glucose after intake of 75 gram oral glucose

    2 hours

Study Arms (1)

Single

EXPERIMENTAL
Biological: Glucose

Interventions

GlucoseBIOLOGICAL

Oral Intake of Glucose

Single

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All pregnant women

You may not qualify if:

  • Known diabetic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Isra University, Karachi Campus

Karachi, Sindh, 74600, Pakistan

Location

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Glucose

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydrates

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 15, 2019

First Posted

October 16, 2019

Study Start

October 15, 2019

Primary Completion

January 15, 2020

Study Completion

January 15, 2020

Last Updated

October 16, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)