NCT07844161

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:

  1. 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. 2.Phase II (Co-Design): Using insights from Phase I, the researcher will develop a culturally sensitive educational intervention called CODE-MOM.
  3. 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Sep 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Sep 2026Nov 2026

Study Start

First participant enrolled

September 1, 2026

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 28, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

September 28, 2026

Status Verified

September 1, 2026

Enrollment Period

2 months

First QC Date

September 12, 2026

Last Update Submit

September 21, 2026

Conditions

Keywords

pregnancymothermaternaloral health educational Interventionoral health Knowledgeoral health PracticeDental service utilization

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

    baseline and 6 weeks post intervention

  • 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

    baseline and 6 weeks post intervention

Secondary Outcomes (4)

  • 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

Study Arms (1)

single group study

EXPERIMENTAL

all participants completed a pretest, participated in the educational intervention and then at follow up completed posttest.

Behavioral: CODE-MOM

Interventions

CODE-MOMBEHAVIORAL

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.

single group study

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • currently enrolled in another oral health intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
primary investigator

Study Record Dates

First Submitted

September 12, 2026

First Posted

September 28, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

September 28, 2026

Record last verified: 2026-09