CO-DEsigning Maternal Oral Health Educational Intervention Model to Improve Knowledge, Practice, and Dental Service Utilization Among Pregnant Women: (CODE-MOM) Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 34
- Primary Endpoint
- To assess change in oral health knowledge score,
Study Overview
Brief Summary
This research follows a mixed-method exploratory sequential design. It will take place at the Antenatal and Dental Outpatient Departments (OPD) of Dow University of Health Sciences (Ojha Campus) in Karachi. This site is ideal provides access to both obstetricians and dental professionals.
The study is divided into four distinct phases:
- Phase I (Qualitative Exploration): The researcher will conduct focus group discussions (FGDs) with pregnant women and In-depth Interviews (IDIs) with healthcare professionals (dentists and obstetricians) to identify specific barriers to dental care and understand stakeholder perspectives.
- Phase II (Co-Design): Using insights from Phase I, the researcher will develop a culturally sensitive educational intervention called CODE-MOM.
- Phase III (Baseline & Intervention): Pregnant women in their first trimester will be recruited. They will complete a questionnaire on their knowledge and practices, followed by a clinical oral examination to record their dental health status. Participants will then receive an educational intervention and biweekly booster messages via WhatsApp to reinforce healthy behaviors.
- Phase IV (Evaluation): Six weeks later, participants will undergo a follow-up. The questionnaire will be re-administered, and a follow up examination will take place to measure improvements. A feedback survey will assess how acceptable and feasible the program was for them.
The study expects to show a significant improvement in maternal oral health knowledge, practices, and the utilization of dental services. By integrating oral health education into routine pregnancy care, the project aims to reduce dental complications and lay a healthier foundation for both mothers and their children.
Detailed Description
Study Design:
The study will follow a mixed-method approach with an exploratory interventional sequential research design. Qualitative insights will enable the development of a more tailored, patient-centered health educational intervention. The subsequent quantitative phase will follow a quasi-experimental pretest-posttest design without randomization.
Study Setting:
Data collection will take place in the department of Obstetrics and Gynecology- Unit II, of DUHS and dental OPD, Dr. Ishrat-ul-Ebad Khan Institute of Oral Health Sciences (Ojha campus)
Data collection procedure:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •currently pregnant (first trimester, gestational age ≤12weeks)
- •aged 18 years or older
- •able to understand and read Urdu
- •receiving antenatal care at the study site and intends to deliver at the study site.
- •access to a smart phone
- •Self-reported dental pain/bleeding gums during pregnancy
Exclusion Criteria
- •currently enrolled in another oral health intervention
Arms & Interventions
single group study
all participants completed a pretest, participated in the educational intervention and then at follow up completed posttest.
Intervention: CODE-MOM (Behavioral)
Outcomes
Primary Outcomes
To assess change in oral health knowledge score,
Time Frame: baseline and 6 weeks post intervention
measured through a validated interviewer- administered questionnaire assessing knowledge of oral health during pregnancy, scored 0 - \[max\]; higher scores indicate greater knowledge
To assess change in oral health practice score,
Time Frame: baseline and 6 weeks post intervention
measured through a validated interviewer- administered questionnaire assessing oral health related practices during pregnancy, scored 0 - \[max\]; higher scores indicate better self-reported practices
To assess change in dental service utilization score,
Time Frame: baseline and 6 weeks post intervention
proportion of participants reporting utilization of dental services during pregnancy assessed via a validated interviewer- administered questionnaire, scored 0 - \[max\]; higher scores indicate better self-reported service utilization
Secondary Outcomes
- To assess the satisfaction level among pregnant women for an oral health education intervention in antenatal settings(6 weeks post intervention / at follow up)
- change in DMFT index(baseline and 6 weeks post intervention)
- change in gingival index (GI)(baseline and 6 weeks post intervention)
- change in community periodontal index (CPI)(baseline and 6 weeks post intervention)
Investigators
Hania Shahbaz
primary investigator
Dow University of Health Sciences