Knowledge, Attitude and Practice of Third Trimester Pregnant Mothers Towards Self-Medication in Assiut, Egypt (SM-PREG)

December 7, 2025 updated by: May Mohamed Abdelwahab Mohmoud, Assiut University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

420

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Structured Questionnaire on Self-Medication During Pregnancy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
from 28-40 weeks of gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 28, 2027

Study Registration Dates

First Submitted

November 19, 2025

First Submitted That Met QC Criteria

December 7, 2025

First Posted (Estimated)

December 9, 2025

Study Record Updates

Last Update Posted (Estimated)

December 9, 2025

Last Update Submitted That Met QC Criteria

December 7, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SM-PREG-ASSIUT-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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