Clinical trial NCT06808360: Supportive and Dignified Maternity Care in Public Health Facilities
Official title: Supportive and Dignified Maternity Care (SDMC) - Development and Feasibility Assessment of an Intervention Package for Public Health Systems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior, Health
Lead sponsor: Aga Khan University
Sponsor class: OTHER
Collaborators: name: London School of Hygiene and Tropical Medicine
name: University of Karachi
First posted: 2025-02-05
Enrollment: 314
Sex: ALL
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: SDMC is a theory-driven, inclusive service-delivery package developed using the principles of the human-centered design approach. The model will focus on capacity-building for maternity teams and improving governance and accountability mechanisms within public health facilities. This ensures that all women are treated with compassion and dignity, while also addressing their diverse needs, including disabilities and common mental health conditions. A unique feature of the intervention package is the integration of psychosocial support into routine maternity care, with a principal aim of addressing the psychological needs of birthing women and their companions.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Brief Summary Poor psychosocial support and demeaning care during childbirth in health facilities are common worldwide, particularly in low- and middle-income countries. Despite a policy directive from the World Health Organization (WHO), there is no operational model that effectively demonstrates the incorporation of these guidelines into routine facility-based maternity services. Recent evidence from Pakistan highlights a high rate of reported disrespect and abuse during childbirth, with several health system factors contributing to this compromised care.

This early-phase research aims to develop, implement, and test the feasibility of a Supportive and Dignified Maternity Care (SDMC) service-delivery model. Based on WHO's guiding principles and framework, the model promotes respectful and supportive intrapartum care in public health facilities. The components of the SDMC model include:

Participatory and co-created service-delivery intervention;

Capacity-building of maternity teams (clinical and support staff) through a partnership approach;

Collaborative Care Model;

Patient orientation in the processes of care and their SDMC rights;

Information system (e.g., complaints register);

Accountability mechanisms (e.g., exit interviews); and

Embedding performance reviews.

Using a mixed-method design and extensive data collection before, during, and after the implementation of the intervention, we will assess the coverage of the intervention and its fidelity-the extent to which SDMC guidelines are being adhered to. Challenges faced, changes in maternity teams' understanding and attitudes, and improvements in women's maternity experiences and psychosocial well-being will also inform the success of the intervention.

Evidence from this research will guide further refinements to the SDMC model package. It will provide insights into behavior change among maternity staff and birthing women, as well as estimate the potential effect size to design a larger evaluation and scalability research in diverse health system contexts.

Detailed description: Background:

Respectful and dignified healthcare is a fundamental right for every woman. However, in health facilities, particularly in low- and middle-income countries, women's experiences of maternity care are often characterized by discrimination, poor psychosocial support, and patronizing attitudes from service providers. Such distressing encounters during obstetric care are likely to have adverse effects on both women and newborns. Women with disabilities and mental health needs are especially vulnerable to poor care and the suffering it causes.

Goal and Objectives:

To support inclusive Supportive and Dignified Maternity Care (SDMC) within health systems, particularly from the perspective of:

1. The capacity of service providers, and
2. Accountability and governance.

The specific objectives are to:

ASSESS: Health system challenges and opportunities for inclusive, supportive, and dignified intrapartum care.

DESIGN: A service-delivery model through a participatory, consensus-driven process.

TEST: The feasibility of the model for content and operationalization in health facilities.

Intervention:

The components of the SDMC model include:

Co-created implementation strategy;

Capacity-building of maternity teams (clinical and support staff);

Collaborative care;

Staff and patient feedback; and

Accountability and governance (performance review).

Methods:

The project will span a period of twenty-four months. Using a mixed-method design, data will be collected at different time intervals to assess the feasibility of the intervention. Challenges faced during implementation, changes in maternity teams' understanding and attitudes, and improvements in women's maternity experiences will also inform the success of the intervention.

Expected Outcomes:

A handbook for capacity-building of health facility staff to provide inclusive and dignified maternity care.

An adapted mhGAP manual for labor room staff to provide birthing women with psychosocial support.

An implementation strategy for embedding inclusive SDMC principles within public health systems.

Contextually adapted measurement tools for inclusive, supportive, and dignified care.

Eligibility criteria: Postnatal Women

Inclusion Criteria:

Delivered in a study health facility during the data collection period.

Provided informed consent.

Exclusion Criteria:

Reside outside the demarcated catchment area.

Health Facility Staff

Inclusion Criteria:

Employed at the study health facility.

Provided informed consent.

Exclusion Criteria:

Recently appointed to the health facility (less than 6 months).

Primary outcomes:
measure: Mean score of women's experiences of supportive and dignified maternity care
timeFrame: Women will be interviewed at baseline. It will follow a six month intervention period. At the end of intervention endline survey will be conducted somewhere Sep - Dec 2021.
Secondary outcomes:
measure: Perception of service providers about feasibility of SDMC intervention
timeFrame: Endline assessment that will be done at the end of a six month intervention period. The assessment will be done in September-November 2021.
Other outcomes:
Locations:
city: Thatta
country: Pakistan
facility: Thatta Project Office
state: Sindh
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Bilal Iqbal Avan, PhD
role: PRINCIPAL_INVESTIGATOR
References: