About this trial
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:
1. 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. 2. Phase II (Co-Design): Using insights from Phase I, the researcher will develop a culturally sensitive educational intervention called CODE-MOM. 3. 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. 4. 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Single group
Treatments tested in this trial
CODE-MOM
BehavioralPregnant women will be assessed at baseline for oral health knowledge, practice and dental service utilization followed by a clinical oral examination using 3 standard indices (DMFT, GI, CPI). At baseline patients will be counselled in one-to-one interaction with a practicing dentist on their current oral health status and oral health challenges they might face in pregnancy, later a WhatsApp group will be created with the pregnant women and educational messages will be sent to reinforce oral health behaviours and also for women to ask about any issue they might face regarding oral health in pregnancy. The intervention will include biweekly messages for a duration of 6 weeks and at post intervention women will be assessed for their knowledge, practice and dental service utilization with the same questionnaire followed by standard indices (DMFT, GI, CPI) and a feedback survey to assess patient satisfaction level about the oral health educational intervention delivered.
Treatment groups
Trial outcomes
Primary outcomes
To assess change in oral health knowledge score,
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,
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,
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
assessed via an interviewer-administered feedback survey.
change in DMFT index
number of decayed, missing, filled teeth per participant assessed by clinical oral examination using WHO DMFT index scored 0-28; 0 indicating caries-free status and higher scores will reflect greater lifetime caries experience.
change in gingival index (GI)
Loe and Silness gingival index, scored 0-3; higher score indicates worse gingival inflammation/condition, assessed by oral examination
change in community periodontal index (CPI)
WHO community periodontal index score, assessed by clinical oral examination score 0-4; higher scores are indicative of worse periodontal conditions and pocketing
Locations
Sponsors and contacts
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