InfectionsantibioticNCT05810935
Safety of Antibiotic Intake During Pregnancy
An observational study of Infections, run by Al-Azhar University.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infections
- How many people
- 384 participants
- Where
- No sites listed yet
- Study dates
- May 2023to May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- 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.
Who may be able to join
- pregnant women at any gestational age
Who cannot join
- pregnant women who refused to participate
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Safety of Antibiotic Intake During Pregnancy: Results of Questionnaire of Pregnant Women in Two Arab Countries
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 .
Read the 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 .
- Conditions
- Infections
- Keywords
- antibiotics, infection
- Medical subject headings
- Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion ,an average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study startMay 2023 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionsStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Ibrahim Abd Elrehim, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05810935
- Sponsor's protocol ID
- DFM-IRB 00012367-23-03-004
- Acronym
- antibiotic
- Status last verified
- Apr 2023
- First submitted
- 29 Mar 2023
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Antibiotic Intake During Pregnancy: Results of Questionnaire of Pregnant Women in Two Arab Countries
- ClinicalTrials.gov ID
- NCT05810935
- Acronym / sponsor ID
- antibiotic / DFM-IRB 00012367-23-03-004
- Conditions
- Infections
- Keywords
- antibiotics, infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- May 2023 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 13 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- pregnant women at any gestational age
Key exclusion criteria (1 listed)
- pregnant women who refused to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with antibiotic-related side effects
Time frame: through study completion ,an average of one year
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Infections, run by Al-Azhar University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eman Ibrahim Abd Elrehim, Lecturer (02 01110985494 ext. egypt, ahmedea2003@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with antibiotic-related side effects (time frame: through study completion ,an average of one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.