Safety of Antibiotic Intake During Pregnancy | NCT05810935

Studies
Safety of Antibiotic Intake During Pregnancy

NCT05810935

Sponsor

Al-Azhar University

Status

Unknown status

Last Update Posted

Apr 13, 2023Actual

Enrollment

384Estimated

Phase

Not provided

Conditions

Infections

Interventions

Not provided

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

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

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

May 2023Estimated

Primary Completion Date

Jan 2024Estimated

Completion Date

May 2024Estimated

First Submitted Date

Mar 29, 2023

First Submission Date that Met QC Criteria

Apr 11, 2023

First Posted Date

Apr 13, 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 11, 2023

Last Update Posted Date

Apr 13, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Eman Ibrahim Abd Elrehim, Lecturer in Department of obstetrics and gynecology, Damietta Faculty of Medicine, Al-Azhar University, Al-Azhar UniversityPrincipal Investigator

Lead Sponsor

Al-Azhar UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

this study will be conducted to assess the knowledge of the pregnant females regarding safety of antibiotic intake ,also their attitude toward any prescribed antibiotics during their pregnancy .

Detailed Description

this study will be conducted on pregnant females from two Arab countries to assess their knowledge and attitude toward any prescribed antibiotics while they are pregnant .Also to assess any malpractice while their intake for any antibiotics . this study is a cross sectional study that will involve a questionnaire including the three mentioned domains .

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

384Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with antibiotic-related side effects	using a questionnaire to measure the knowledge and attitude of pregnant women toward antibiotics that were taken during pregnancy and any malpractice during its intake	through study completion ,an average of one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

pregnant women at any gestational age

Exclusion Criteria:

pregnant women who refused to participate

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

this study is an observational cross sectional study that will be conducted on pregnant female above the age of 18 years old iwith exclusion of any female with any psychological disability.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eman Ibrahim Abd Elrehim, Lecturer	Contact	02 01110985494	egypt	ahmedea2003@gmail.com

Overall Officials

Not provided

Locations

Not provided

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
D007239	Infections

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided