1. BACKGROUND

Rationale: WHO Global Strategy on Oral Health (2023–2030) and the NOHP emphasize on integrating oral health into maternal care, pregnant women and new mothers, yet it remains underserved due to systemic gaps and lack of cost-effective delivery models. Novelty: Attempt to co-develop a scalable, cost-effective oral healthcare delivery model for pregnant women, new mothers and children, integrated into RMNCAH+N via frontline workers in India. The proposal focuses on five socio-geographically diverse districts, aiming to create a high-coverage, high-quality delivery model integrated into existing antenatal and postnatal packages and national health programs.

1.1. Objectives

i)  Co-develop a facility- and community-based antenatal and postnatal oral healthcare intervention model based on mixed-method formative research and its optimization through iterative cycles.

ii) Evaluate optimized model for implementation outcomes and maternal and child health outcomes, compared to usual care.

iii) Evaluate financial and economic costs, cost-effectiveness, and budget-impact implementing the integrated oral healthcare model versus usual care.

2. METHODS

2.1. Study Design

A multi-site, mixed-method, type-II hybrid stepped-wedge cluster randomized effectiveness-implementation research design will be used.

Study setting and population: All eligible pregnant women enrolled at AAM-SCs in the selected geographic study area will be subjected to the full-scale implementation.  Anticipating 4,320 mother-child dyads per site over 2 years of implementation. Anticipated on approximately 25,000 mother-child dyads (in total from all sites) through approx 2,000 health workers/professionals (in total from all sites) in a study duration of 39 months. Only a sample population (560 mother–child pairs/site) from the cluster would be evaluated at six evaluation time points cross-sectionally from the target population. Intervention will be delivered both at the facility level (AAM-SC and the related catchment areas) and at the community level (home visits and community meetings).

2.2. Intervention package

This package would be built upon the Operational Guidelines for Oral Health Care at Health and Wellness Centres, part of comprehensive primary health care. It will include the following components:

i)      Oral health educational and behavioral intervention (OHE)

ii)  Oral disease screening and management: Trained ANMs, CHOs, ASHAs, and AWWs will conduct oral disease screenings during routine antenatal and postnatal home visits, as well as during community meetings, for both mothers and newborns/infants, as per RMNCAH+N.

iii)   Appropriate referral for clinical interventions

iv)    Follow-up for continuity of care where applicable.

2.3. Outcome measures

2.3.1.      Implementation outcome measures:

Include Acceptability, Adoption, Coverage, and Fidelity.

2.3.2.      Effectiveness outcome measures:

1.  Primary effectiveness outcome: Dental caries status of pregnant women/ new mothers

2.  Periodontal health status and Oral hygiene of pregnant women/ new mothers

3.  Knowledge, attitude and practice (KAP) of pregnant women/ new mothers, ANMs, CHOs, ASHAs, and AWWs.

4.  Birth weight and adverse pregnancy outcomes such as stillbirth, etc.

5.  ECC of infants will be determined at one year of age only at baseline and endline survey.

2.3.3.      Economic Evaluation

Costing over 30 randomly selected AAM-SCs to estimate the Total cost and cost per beneficiary; Incremental cost-effectiveness ratios; Budget impact over 5 years; Analysis adjusts for inflation, discounting, and socio-demographic heterogeneity.

Data collection includes Qualitative interviews, focus groups for formative research; Process and outcome documentation (KAP assessments, pilot and full-scale monitoring).

2.4. Study implementation phases

The study will span 39 months and is divided into four phases. Phase I, the preparatory and formative phase, will use a mixed-methods approach focused on preparatory activities and formative data collection to assess current antenatal and postnatal oral healthcare practices, and to identify barriers and facilitators influencing oral healthcare delivery for pregnant women, new mothers, and key stakeholders. Phase II is the pilot phase, where the model will be pilot tested and optimized. Phase III involves full-scale implementation through a stepped-wedge cluster randomized trial, supporting ongoing refinement and adjustment, followed by a maintenance period. The intervention arm includes a facility- and community-based antenatal and postnatal oral health care package offering oral health education, screening, referrals, and follow-up, while the comparison arm will receive usual care with no additional interventions. Cross-sectional surveys will be conducted at baseline and every six months, reaching 25,000 mother-child pairs across five sites. Implementation will be refined at 6-, 12-, 18-, and 24-months using Plan-Do-Study-Act cycles, and informed consent will be obtained from all survey participants. Phase IV is the exit phase, consisting of capacity-building workshops, toolkit development, and dissemination efforts to support wider adoption of the model.