Feasibility of Introducing Midwifery-embodied Community Clinic Model
NCT Number: NCT06466512
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Maternal Death|Newborn Morbidity
Interventions: BEHAVIORAL: Midwifery-embodied care
Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborators: The Laerdal Foundation
Sex: FEMALE
Age: CHILD, ADULT
Enrollment: 70
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-08-01
Completion Date: 2026-01-31

Summary:
Background (brief):

1. Burden: Maternal and neonatal mortality continue to be a serious public health problem in Bangladesh. Facility-based healthcare services reduce the probability of preventable causes of maternal and neonatal death. Community clinics (CCs) are located closer to the community than other healthcare facilities are. However, only 2.8% of all CCs are ready to provide antenatal care (ANC) and 2.4% of these facilities are ready to provide delivery services. Despite the wide acceptance of midwifery care for ANC and delivery services, they are posted only up to the Upazila Health Complexes and at selected Union Health and Family Welfare Centers.
2. Knowledge gap: There is a dearth of evidence on whether the utilisation of ANC, normal vaginal delivery, and postnatal care (PNC) services can be increased if midwives are assigned to CCs to provide these services.
3. Relevance: Midwives were trained to provide antenatal and postnatal care, conduct normal deliveries, and manage CC-specific pregnancy-related complications. Midwives are posted up to union-level facilities, and the Government of Bangladesh has a strategic plan to enable selective community clinics for normal delivery services in addition to antenatal and postnatal care.

Hypothesis (if any): N/A

Objectives: This study aims to assess the feasibility, adoption, acceptability, appropriateness, fidelity, coverage, and possible barriers and enablers of introducing Midwifery-embodied Community Clinic (MCC) model in selected community clinics of Bangladesh.

Methods: We will implement a Midwifery-embodied Community Clinic (MCC) model in two CCs of the Baliakandi sub-district of Rajbari district. Trained midwives will provide ANC, select low-risk pregnant women, conduct their normal deliveries, and provide PNC services in CCs, while the CHCP will provide essential newborn care during NVD. High-risk mothers will be referred to the upper level of healthcare facilities for managment. In addition, counselling services will be provided to mothers by the Health Assistants and Family Welfare Assistants during their domiciliary visits. Transport services using the ambulances of the Upazila Health Complex will be integrated into the model to transport patients to the CCs and upper-level healthcare facilities in case of emergencies.

Outcome measures/variables: The outcome measures will be feasibility, adoption, acceptability, appropriateness, fidelity, coverage, and possible barriers and enablers of the MCC model.

Primary Outcome Measures: Fesibility of the midwifery-embodied community clinic model, We will measure feasibility using qualitative method of data collection. We will conduct in-depth interviews and key-informant interviews to understand the extent to which the midwifery-led care in the primary level of healthcare facility (community clinic) can be introduced, Immediately after the intervention
Secondary Outcome Measures: Acceptability of midwifery-embodied community clinic model, We will measure acceptability using qualitative method of data collection. We will conduct in-depth interviews and key informant interviews using semi-structured guidelinesto understand the perception among stakeholders that the model is agreeable, Immediately after the intervention|Appropriateness of midwifery-embodied community clinic model, We will measure appropriateness using qualitative method of data collection. We will conduct in-depth interviews and key informant interviews using semi-structured guidelines to understand the perceived fit or relevance of the model in the rural area, Immediately after the intervention|Fidelity of midwifery-embodied community clinic model, We will measure fidelity using qualitative method of data collection. We will observe the service provision using semi-structured check-list to determine the degree to which the model was implemented as it was designed, Immediately after the intervention|Barriers and enablers of midwifery-embodied community clinic model, We will conduct in-depth interviews and key informant interviews using semi-structured guidelines to understand the factors creating hindrance in or accelerating up the achievement of the goals of the model, Immediately after the intervention|Proportion of women and newborns with a history of birth in last one year received maternal and newborn healthcare, Denominator: Total number of women and newborn has a history of birth in the past one year.

The degree to which the population received benefits from the model. We will use structured questionnaire to conduct household survey, Immediately after the intervention