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

September 21, 2026 updated by: Hania Shahbaz, Dow University of Health Sciences

CO-DEsigning Maternal Oral Health Educational Intervention Model to Improve Knowledge, Practice, and Dental Service Utilization Among Pregnant Women: (CODE-MOM) Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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:

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

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

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: single group study

all participants completed a pretest, participated in the educational intervention and then at follow up completed posttest.
Behavioral: CODE-MOM

Pregnant 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
baseline and 6 weeks post intervention
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
baseline and 6 weeks post intervention
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
baseline and 6 weeks post intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To assess the satisfaction level among pregnant women for an oral health education intervention in antenatal settings
Time Frame: 6 weeks post intervention / at follow up

assessed via an interviewer-administered feedback survey.
6 weeks post intervention / at follow up
change in DMFT index
Time Frame: baseline and 6 weeks post intervention

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.
baseline and 6 weeks post intervention
change in gingival index (GI)
Time Frame: baseline and 6 weeks post intervention

Loe and Silness gingival index, scored 0-3; higher score indicates worse gingival inflammation/condition, assessed by oral examination
baseline and 6 weeks post intervention
change in community periodontal index (CPI)
Time Frame: baseline and 6 weeks post intervention

WHO community periodontal index score, assessed by clinical oral examination score 0-4; higher scores are indicative of worse periodontal conditions and pocketing
baseline and 6 weeks post intervention

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dow University of Health Sciences

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 12, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 28, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 4645

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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