Third TrimeserSM-PREGNCT07273214
Knowledge, Attitude and Practice of Third Trimester Pregnant Mothers Towards Self-Medication in Assiut, Egypt
An observational study of Third Trimeser, run by Assiut University.
Trial summary
This study aims to assess the knowledge, attitude, and practice (KAP) of third-trimester pregnant women toward self-medication in Assiut, Egypt. Self-medication is a common behavior among pregnant women, often influenced by cultural habits, easy access to medications, and limited awareness of potential risks. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Third Trimeser
- What is being tested?
- Structured Questionnaire on Self-Medication During Pregnancy
- How many people
- 420 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 28 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult
Study population: The study population includes third-trimester pregnant women attending the antenatal care outpatient clinics at Assiut University Hospital and selected primary health care centers in Assiut Governorate, Egypt, during the study period.
Who may be able to join
- Pregnant women in the third trimester (≥28 weeks of gestation)
- Attending antenatal care at Assiut University Hospital or selected primary health centers during the study period
- Willing to participate and able to provide informed consent
Who cannot join
- Pregnant women with known psychiatric disorders or cognitive impairment that may affect questionnaire reliability.
- Women with severe obstetric complications requiring emergency management.
- Women unwilling to participate or unable to complete the interview.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Knowledge, Attitude and Practice of Third Trimester Pregnant Mothers Towards Self-Medication in Assiut, Egypt: A Cross-Sectional Observational Study
This study aims to assess the knowledge, attitude, and practice (KAP) of third-trimester pregnant women toward self-medication in Assiut, Egypt. Self-medication is a common behavior among pregnant women, often influenced by cultural habits, easy access to medications, and limited awareness of potential risks.
Through a structured, interviewer-administered questionnaire, this cross-sectional study will collect data on the prevalence and pattern of self-medication, types of medications used, reasons for use, and sources of information. Participants will be recruited from antenatal care (ANC) clinics at Assiut University Hospital and selected primary health care centers.
The findings of this research will help identify gaps in awareness and guide educational interventions to promote safe medication practices during pregnancy.
Read the detailed description
Self-medication during pregnancy is a significant public health concern, as inappropriate use of medications can lead to adverse maternal and fetal outcomes. In developing countries, including Egypt, the availability of over-the-counter drugs, social beliefs, and lack of regulatory control contribute to this problem. However, data describing the magnitude and determinants of self-medication among pregnant women in Upper Egypt are limited.
This prospective cross-sectional study will be conducted among third-trimester pregnant women attending antenatal clinics at Assiut University Hospital and selected primary health care centers in Assiut, Egypt. A structured, pretested questionnaire will be used to collect data through face-to-face interviews by trained researchers.
The questionnaire covers sociodemographic data, obstetric history, knowledge about medication use during pregnancy, attitudes toward self-medication, and actual self-medication practices. It also includes items about commonly used drug types, sources of information, and reasons for self-medication.
A total of approximately 420 participants will be recruited using convenience sampling. Data will be analyzed using IBM SPSS version 29. Descriptive and inferential statistics will be applied to identify significant associations between self-medication practices and participant characteristics.
The study aims to:
Determine the prevalence of self-medication among third-trimester pregnant women.
Assess knowledge and attitudes regarding medication safety during pregnancy.
Identify the common drugs used and reasons for self-medication.
Provide recommendations for awareness and health education programs targeting pregnant women.
Ethical approval has been obtained from the Faculty of Medicine, Assiut University. Written informed consent will be obtained from all participants before enrollment. No intervention or experimental drug will be administered, and participant confidentiality will be maintained throughout the study.
The results of this research will contribute to improving antenatal care and maternal health policies by emphasizing the need for education about rational medication use during pregnancy.
- Conditions
- Third Trimeser
- Being tested
- Structured Questionnaire on Self-Medication During Pregnancy
- Keywords
- anaemia, pregnancy, diabetis
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Questionnaire on Self-Medication During PregnancyOther
A structured, pretested interviewer-administered questionnaire designed to assess the knowledge, attitude, and practice (KAP) of pregnant women in their third trimester regarding self-medication during pregnancy. The tool includes sections on sociodemographic data, pregnancy history, knowledge of medication use, attitudes toward drug safety, and patterns of self-medication. It is used once during a single face-to-face interview. No drug, biological, or device is administered.
| Study group | Role | What they receive |
|---|---|---|
| Third-trimester pregnant women (Assiut ANC cohort) | A single observational cohort of pregnant women in their third trimester (≥ 28 weeks gestation) who attend antenatal care (ANC) clinics at Assiut University Hospital and selected primary health centers in Assiut, Egypt. Participants are interviewed once using a structured, pretested, interviewer-administered questionnaire to assess knowledge, attitude and practice (KAP) regarding self-medication during pregnancy, types of medicines used, reasons for use, and sources of information. Data collection is non-interventional and confidentiality is maintained. Receives: Other: Structured Questionnaire on Self-Medication During Pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of self-medication among third-trimester pregnant women
The primary outcome will be the proportion (%) of third-trimester pregnant women who report self-medicating with any pharmaceutical or herbal product during their current pregnancy. Data will be collected using a structured interviewer-administered questionnaire assessing medication type, reason for use, and source of information. Prevalence will be calculated as the number of women reporting self-medication divided by the total number of surveyed participants.
Measured: from 28-40 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start1 Dec 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Third TrimeserStudies of the same condition, open and under way.
- More trials run by Assiut 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
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, May Mohamed Abdelwahab Mohmoud, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07273214
- Sponsor's protocol ID
- SM-PREG-ASSIUT-2025
- Acronym
- SM-PREG
- Status last verified
- Dec 2025
- First submitted
- 19 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kashif MML, El-Tahty SE: An assessment of the factors influencing the use of over-the-counter medication during the second trimester of pregnancy, Egypt. Int J Nurs Sci. 2018, 12:99-107.
World Health Organization, (2000). Guidelines for the regulatory assessment of medicinal products for use in self-medication. https://apps.who.int/iris/handle/10665/ 66154
Hughes CM, McElnay JC, Fleming GF. Benefits and risks of self medication. Drug Saf. 2001;24(14):1027-37. doi: 10.2165/00002018-200124140-00002.
PubMed 11735659
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knowledge, Attitude and Practice of Third Trimester Pregnant Mothers Towards Self-Medication in Assiut, Egypt: A Cross-Sectional Observational Study
- ClinicalTrials.gov ID
- NCT07273214
- Acronym / sponsor ID
- SM-PREG / SM-PREG-ASSIUT-2025
- Conditions
- Third Trimeser
- Keywords
- anaemia, pregnancy, diabetis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 9 Dec 2025 (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 aims to assess the knowledge, attitude, and practice (KAP) of third-trimester pregnant women toward self-medication in Assiut, Egypt. Self-medication is a common behavior among pregnant women, often influenced by cultural habits, easy access to medications, and limited awareness of potential risks.
Through a structured, interviewer-administered questionnaire, this cross-sectional study will collect data on the prevalence and pattern of self-medication, types of medications used, reasons for use, and sources of information. Participants will be recruited from antenatal care (ANC) clinics at Assiut University Hospital and selected primary health care centers.
The findings of this research will help identify gaps in awareness and guide educational interventions to promote safe medication practices during pregnancy.
Detailed description
Self-medication during pregnancy is a significant public health concern, as inappropriate use of medications can lead to adverse maternal and fetal outcomes. In developing countries, including Egypt, the availability of over-the-counter drugs, social beliefs, and lack of regulatory control contribute to this problem. However, data describing the magnitude and determinants of self-medication among pregnant women in Upper Egypt are limited.
This prospective cross-sectional study will be conducted among third-trimester pregnant women attending antenatal clinics at Assiut University Hospital and selected primary health care centers in Assiut, Egypt. A structured, pretested questionnaire will be used to collect data through face-to-face interviews by trained researchers.
The questionnaire covers sociodemographic data, obstetric history, knowledge about medication use during pregnancy, attitudes toward self-medication, and actual self-medication practices. It also includes items about commonly used drug types, sources of information, and reasons for self-medication.
A total of approximately 420 participants will be recruited using convenience sampling. Data will be analyzed using IBM SPSS version 29. Descriptive and inferential statistics will be applied to identify significant associations between self-medication practices and participant characteristics.
The study aims to:
Determine the prevalence of self-medication among third-trimester pregnant women.
Assess knowledge and attitudes regarding medication safety during pregnancy.
Identify the common drugs used and reasons for self-medication.
Provide recommendations for awareness and health education programs targeting pregnant women.
Ethical approval has been obtained from the Faculty of Medicine, Assiut University. Written informed consent will be obtained from all participants before enrollment. No intervention or experimental drug will be administered, and participant confidentiality will be maintained throughout the study.
The results of this research will contribute to improving antenatal care and maternal health policies by emphasizing the need for education about rational medication use during pregnancy.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Third-trimester pregnant women (Assiut ANC cohort) | – | Other: Structured Questionnaire on Self-Medication During PregnancyA single observational cohort of pregnant women in their third trimester (≥ 28 weeks gestation) who attend antenatal care (ANC) clinics at Assiut University Hospital and selected primary health centers in Assiut, Egypt. Participants are interviewed once using a structured, pretested, interviewer-administered questionnaire to assess knowledge, attitude and practice (KAP) regarding self-medication during pregnancy, types of medicines used, reasons for use, and sources of information. Data collection is non-interventional and confidentiality is maintained. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population includes third-trimester pregnant women attending the antenatal care outpatient clinics at Assiut University Hospital and selected primary health care centers in Assiut Governorate, Egypt, during the study period.
Key inclusion criteria (3 listed)
- Pregnant women in the third trimester (≥28 weeks of gestation)
- Attending antenatal care at Assiut University Hospital or selected primary health centers during the study period
- Willing to participate and able to provide informed consent
Key exclusion criteria (3 listed)
- Pregnant women with known psychiatric disorders or cognitive impairment that may affect questionnaire reliability.
- Women with severe obstetric complications requiring emergency management.
- Women unwilling to participate or unable to complete the interview.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Questionnaire on Self-Medication During PregnancyA structured, pretested interviewer-administered questionnaire designed to assess the knowledge, attitude, and practice (KAP) of pregnant women in their third trimester regarding self-medication during pregnancy. The tool includes sections on sociodemographic data, pregnancy history, knowledge of medication use, attitudes toward drug safety, and patterns of self-medication. It is used once during a single face-to-face interview. No drug, biological, or device is administered. | Other | Third-trimester pregnant women (Assiut ANC cohort) |
Primary outcome
Prevalence of self-medication among third-trimester pregnant women
Time frame: from 28-40 weeks of gestation
The primary outcome will be the proportion (%) of third-trimester pregnant women who report self-medicating with any pharmaceutical or herbal product during their current pregnancy. Data will be collected using a structured interviewer-administered questionnaire assessing medication type, reason for use, and source of information. Prevalence will be calculated as the number of women reporting self-medication divided by the total number of surveyed participants.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Results publicationKashif MML, El-Tahty SE: An assessment of the factors influencing the use of over-the-counter medication during the second trimester of pregnancy, Egypt. Int J Nurs Sci. 2018, 12:99-107.
- Results publicationWorld Health Organization, (2000). Guidelines for the regulatory assessment of medicinal products for use in self-medication. https://apps.who.int/iris/handle/10665/ 66154
- Results publication: PubMed 11735659Hughes CM, McElnay JC, Fleming GF. Benefits and risks of self medication. Drug Saf. 2001;24(14):1027-37. doi: 10.2165/00002018-200124140-00002.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Third Trimeser, run by Assiut 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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 9 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact may mohammed abdelwahab, resident (01004231328, mai.15235467@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of self-medication among third-trimester pregnant women (time frame: from 28-40 weeks of gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07273214, which also lists 3 linked publications.
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 9 Dec 2025.