[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657850":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":40,"studyPopulation":33,"armGroups":41,"interventions":48,"overallOfficials":33,"centralContacts":33,"locations":33,"responsibleParty":54,"collaborators":33,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":51,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":66,"minAge":67,"maxAge":33,"enrollmentInfo":68,"targetDuration":33,"studyType":71,"phases":72,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":84,"whyStopped":33,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":33},{"fullName":5,"class":6},"Dow University of Health Sciences","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":33},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"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","baseline and 6 weeks post intervention",{"measure":14,"description":15,"timeFrame":12},"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",{"measure":17,"description":18,"timeFrame":12},"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",[20,24,27,30],{"measure":21,"description":22,"timeFrame":23},"To assess the satisfaction level among pregnant women for an oral health education intervention in antenatal settings","assessed via an interviewer-administered feedback survey.","6 weeks post intervention \u002F at follow up",{"measure":25,"description":26,"timeFrame":12},"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.",{"measure":28,"description":29,"timeFrame":12},"change in gingival index (GI)","Loe and Silness gingival index, scored 0-3; higher score indicates worse gingival inflammation\u002Fcondition, assessed by oral examination",{"measure":31,"description":32,"timeFrame":12},"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",null,{"allocation":35,"interventionModel":36,"interventionModelDescription":33,"primaryPurpose":37,"observationalModel":33,"timePerspective":33,"maskingInfo":38},"NA","SINGLE_GROUP","PREVENTION",{"masking":39,"maskingDescription":33,"whoMasked":33},"NONE","Study Design:\n\nThe 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.\n\nStudy Setting:\n\nData 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)\n\nData collection procedure:\n\nPregnant 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.\n\nResponses 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).\n\nQuestions 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.\n\nParticipants 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.\n\nPhase I (qualitative FGDs and IDIs) Focus group discussions (FGDs)\n\nStudy setting:\n\nDepartment of Obstetrics and Gynecology- Unit II, of Dow University Hospital, Ojha campus\n\nStudy population:\n\nPregnant women\n\nSampling Technique:\n\nPurposive sampling In-depth interviews (IDIs)\n\nStudy setting:\n\nDepartment 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)\n\nStudy population:\n\nHealthcare professionals (Obstetricians and Dentists)\n\nSampling Technique:\n\nPurposive sampling\n\nSample Size:\n\nFor 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.\n\nData Collection Procedure:\n\nThe 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.\n\nPhase 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.\n\nPhase III (quantitative data collection (baseline), co-designed intervention delivered)\n\nStudy Setting:\n\nDepartment of Obstetrics and Gynecology- Unit II, of Dow University Hospital, Ojha campus\n\nStudy Population:\n\nPregnant 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.\n\nData 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.\n\nPhase 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.",[42],{"label":43,"type":44,"description":45,"interventionNames":46},"single group study","EXPERIMENTAL","all participants completed a pretest, participated in the educational intervention and then at follow up completed posttest.",[47],"Behavioral: CODE-MOM",[49],{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":33},"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.",[43],{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"PRINCIPAL_INVESTIGATOR","Hania Shahbaz","primary investigator","100657850","maternal-oral-health-educational-intervention-to-improve-knowledge-practice-and-dental-service-utilization-100657850",false,"NCT07844161","Maternal Oral Health Educational Intervention to Improve Knowledge, Practice and Dental Service Utilization","CO-DEsigning Maternal Oral Health Educational Intervention Model to Improve Knowledge, Practice, and Dental Service Utilization Among Pregnant Women: (CODE-MOM) Study","Inclusion Criteria:\n\n* currently pregnant (first trimester, gestational age ≤12weeks)\n* aged 18 years or older\n* able to understand and read Urdu\n* receiving antenatal care at the study site and intends to deliver at the study site.\n* access to a smart phone\n* Self-reported dental pain\u002Fbleeding gums during pregnancy\n\nExclusion Criteria:\n\n• currently enrolled in another oral health intervention",true,"FEMALE","18 Years",{"count":69,"type":70},34,"ESTIMATED","INTERVENTIONAL",[35],"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.\n\nThe study is divided into four distinct phases:\n\n1. 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.\n2. Phase II (Co-Design): Using insights from Phase I, the researcher will develop a culturally sensitive educational intervention called CODE-MOM.\n3. 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.\n4. 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.\n\nThe 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.",[75],"Oral Health",[77,78,79,80,81,82,83],"pregnancy","mother","maternal","oral health educational Intervention","oral health Knowledge","oral health Practice","Dental service utilization","NOT_YET_RECRUITING","2026-09-21",{"date":87,"type":88},"2026-09-28","ACTUAL",{"date":90,"type":70},"2026-09",{"date":92,"type":70},"2026-11",{"name":5,"class":6}]