Maternal Oral Health Educational Intervention to Improve Knowledge, Practice and Dental Service Utilization (CODE-MOM)

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:

Pregnant women will be recruited after they are screened for their eligibility. Simple screening questions about their current oral health will be asked. If two or more questions are answered "Yes" the participant will be considered eligible and enrolled for the study. Purpose of the study and its potential benefits will be clearly communicated to all the subjects. Participants will be assured of their confidentiality, voluntariness, and the right to withdraw at any point without any consequences to their standard care. Once a participant has been screened and has read the information sheet, they will be provided with 10 minutes to decide whether to provide consent. Those who agree will provide with written informed consent prior to enrollment. Data will be collected by the primary investigator herself, who is a qualified dentist by profession and holds prior experience in research, involving similar populations where she has participated in data collection through REDCap thus increasing the present study's reliability and consistency in data gathering. Data will be pseudo-anonymized and stored securely in password protected databases accessible only to authorized personnel.

Responses will be categorized after using a questionnaire developed by Hebbal et al. 2025 through REDCap. The questionnaire has a face validity of (86%) and a content validity ratio (CVR = 0.80).

Questions of the semi-structured guide are based on literature review which explored barriers and enablers to prenatal oral health care in pregnant women. Probes will be used to elicit full detail to a particular question and to encourage participants, thus providing in depth detail. Back translation is used to translate the tools in the target population's language (Urdu) that will be conceptually equivalent to the original instruments. Triangulation will be employed to enhance the rigor of the study. The quantitative component of the study will be guided by TREND (Transparent Reporting of Evaluations with Nonrandomized Designs) 22 item check list while the conduct and reporting of the qualitative component will follow the Consolidated Criteria for Reporting Qualitative studies (COREQ) 32-item checklist.

Participants will receive reminder messages through WhatsApp, the most widely used mobile messaging application globally, and a common communication tool among pregnant women, making it an effective platform for delivering health interventions.

Phase I (qualitative FGDs and IDIs) Focus group discussions (FGDs)

Study setting:

Department of Obstetrics and Gynecology- Unit II, of Dow University Hospital, Ojha campus

Study population:

Pregnant women

Sampling Technique:

Purposive sampling In-depth interviews (IDIs)

Study setting:

Department of Obstetrics and Gynecology- Unit II, of Dow University Hospital, Ojha campus (for obstetricians) Dr. Ishrat-ul-Ebad Khan Institute of Oral Health Sciences of Dow University Hospital, Ojha campus (for dentists)

Study population:

Healthcare professionals (Obstetricians and Dentists)

Sampling Technique:

Purposive sampling

Sample Size:

For qualitative component, the goal is thematic saturation (the point when no new information emerges). We will conduct two FGDs among pregnant women, however if new themes emerge from the data and we identify the need for additional perspectives, FGDs will be conducted until thematic saturation is achieved. For healthcare providers we aim to conduct ten IDIs in total to achieve data saturation.

Data Collection Procedure:

The first phase of the study will gather data through FGDs from pregnant women and IDIs among healthcare providers through a semi-structured guide with open ended responses developed to explore the existing knowledge and perceived barriers in assessing oral healthcare during pregnancy. All group discussions and interviews will be conducted in Urdu and audio recorded. Recordings will be transcribed verbatim. FGDs will be carried out until data sufficiency is achieved. The findings from the qualitative component are intended to inform the development of a co-designed, oral health education intervention to improve oral health as part of pregnancy care among expectant mothers.

Phase II (tool development, co-designing educational intervention) Responses from the qualitative phase (phase I) will help co-design the educational intervention to tailor it to the needs and beliefs of Pakistani pregnant women. Based on the perspectives of the healthcare professionals and pregnant women, educational content, and the mode of the delivery for intervention will be devised. While considering logistical constraints, operational feasibility, and available resources, we will adopt the most appropriate and effective mode of intervention.

Phase III (quantitative data collection (baseline), co-designed intervention delivered)

Study Setting:

Department of Obstetrics and Gynecology- Unit II, of Dow University Hospital, Ojha campus

Study Population:

Pregnant women Sampling Technique Purposive sampling Sample Size Open Epi sample size calculator is used for the estimation of sample size taking confidence interval 95%, margin of error 4%, and reported frequent utilization of dental services by pregnant women in a previous study 1.5% (Hebbal et al), the estimated sample size came out to be 36. After including a 20% drop-out rate, we will include 43 subjects in the study.

Data Collection Procedure Following informed consent, study data will be collected and managed using REDCap version 15.x, a secure web-based application designed for building and managing online surveys and databases hosted at Department of Obstetrics and Gynecology- Unit II, of Dow University Hospital, Ojha campus. The questionnaire will take around 10-15 minutes per individual. It will include 34 items in total that will collect information on demographic characteristics, oral health knowledge, practice and dental service utilization of pregnant women This will help us observe how expectant mothers maintain and assess dental care in antenatal period. Eventually, a clinical oral examination will be conducted by a dental professional to record oral health scores (DMFT, GI, CPI) at baseline. Based on the findings of FGDs and IDIs, the co-designed educational intervention will be delivered to enrolled participants. Booster messages will be sent through a designated WhatsApp group biweekly aimed to reinforce key educational behaviors among pregnant women for a sustained behavior change. Periodic reminder messages will be sent 24 hours after initial distribution to maximize response rates.

Phase IV: (quantitative data collection post intervention) Study Setting Department of Obstetrics and Gynecology- Unit II, of Dow University Hospital, Ojha campus Study Population Pregnant women Sample Size Same as mentioned in (phase III) Sampling Technique Purposive sampling Data Collection Procedure Six-weeks post-intervention, third and final phase of data collection will be conducted for reassessment. The same questionnaire that was used at baseline will be re-administered to evaluate changes in participants' knowledge, practice and oral health seeking behavior in managing oral health during pregnancy. Additionally, a follow-up clinical oral examination will be conducted (DMFT, GI, and CPI scores) to reassess the oral health status and validate our findings. A feedback form will also be led by interviewer to assess patient satisfaction. This will help us evaluate the acceptability and feasibility of the intervention and inquire if such an initiative will be logistically feasible and operational for scalability in future.