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Completed

NCT Number: NCT06808360

Supportive and Dignified Maternity Care in Public Health Facilities

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.

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Key information

Conditions

Behavior, Health Behavior Health Behavior

Age range

15 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thatta Project Office

Thatta, Sindh, Pakistan

About this study

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:

  • The capacity of service providers, and
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Supportive and Dignified Maternity Care

Behavioral

SDMC is a theory-driven, inclusive service-delivery package which will be developed using the principles of the human-centred design approach. The model will include capacity-building of maternity teams, and the improvement of governance and accountability mechanisms within public health facilities to ensure that all women are treated with compassion and dignity, while also catering for their diverse needs, including disabilities and common mental health conditions. The integration of psychosocial support in routine maternity care will be a unique feature of the intervention package, a principal aim of which is to address the psychological needs of birthing women and their companions.

Primary outcomes

  1. Mean score of women's experiences of supportive and dignified maternity care

    Time frame: 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.

    The Women's experiences of SDMC will be assessed using a Mistreatment standard tool that will be adapted in the Pakistani context. The score range will be 0-100 where a higher score will indicate higher level of mistreatment whereas lower score will reflect better care.

Secondary outcomes

  1. Perception of service providers about feasibility of SDMC intervention

    Time frame: Endline assessment that will be done at the end of a six month intervention period. The assessment will be done in September-November 2021.

    Service providers will be qualitative enquired about their experiences of training and how feasible they found to implement the intervention. They will be asked about challenges and suggestions for improvements

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Collaborators

  • London School of Hygiene and Tropical Medicine
  • University of Karachi

Registry information

Official study title

Supportive and Dignified Maternity Care (SDMC) - Development and Feasibility Assessment of an Intervention Package for Public Health Systems

Acronym: SDMC

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Feb 5, 2025
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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