Helicobacter Pylori Screening at Sohag University | NCT05835076

Studies
Helicobacter Pylori Screening at Sohag University

NCT05835076

Sponsor

Sohag University

Status

Unknown status

Last Update Posted

Apr 28, 2023Actual

Enrollment

80Estimated

Phase

Not provided

Conditions

In Early Pregnancy

Interventions

Stool antigen test

Countries

Not provided

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2023Estimated

Primary Completion Date

Apr 2024Estimated

Completion Date

Jun 2024Estimated

First Submitted Date

Apr 18, 2023

First Submission Date that Met QC Criteria

Apr 18, 2023

First Posted Date

Apr 28, 2023Actual

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

Apr 18, 2023

Last Update Posted Date

Apr 28, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Amr Ayman Hassan, Helicobacter pylori screening in hyperemesis gravidarum in early pregnancy, Sohag UniversityPrincipal Investigator

Lead Sponsor

Sohag UniversityOTHER

Collaborators

Not provided

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Screen of Helicobacter pylori in hyperemesis gravidarum in early pregnancy to detect the impact of the severity of the disease on pregnant women

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Stool antigen test	Diagnostic Test	Antigen test in the stool analysis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Positive	Positive for Helicobacter pylori	2 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

pregnant woman <16wk

Exclusion Criteria:

pregnant woman >16wks

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Pregnant women

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Cross sectional study to screen Helicobacter pylori in hyperemesis gravidarum

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Jul 11, 2024
Reset	Oct 10, 2024

Submission Tracking

Estimated Results First Submitted Date

Jul 11, 2024

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jul 11, 2024			Oct 10, 2024