Single Non-fasting OGTT Versus Fasting OGTT for Screening... | NCT04129190

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

NCT04129190

Sponsor

Isra University

Status

Unknown status

Last Update Posted

Oct 16, 2019Actual

Enrollment

225Actual

Phase

Phase 2

Conditions

Diabetes in Pregnancy

Interventions

Glucose

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 15, 2019Estimated

Primary Completion Date

Jan 15, 2020Estimated

Completion Date

Jan 15, 2020Estimated

First Submitted Date

Oct 15, 2019

First Submission Date that Met QC Criteria

Oct 15, 2019

First Posted Date

Oct 16, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 15, 2019

Last Update Posted Date

Oct 16, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

225Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single	Experimental		Biological: Glucose

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Glucose	Biological	Oral Intake of Glucose	Single

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All pregnant women

Exclusion Criteria:

Known diabetic

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Isra University, Karachi Campus		Karachi	Sindh	74600	Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016640	Diabetes, Gestational

Ancestor Terms

ID	Term
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D003920	Diabetes Mellitus

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005947	Glucose

Ancestor Terms

ID	Term
D006601	Hexoses
D009005	Monosaccharides
D000073893	Sugars
D002241	Carbohydrates

Browse Leaves

Not provided

Browse Branches

Not provided