Viewing Study NCT06808360


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Study NCT ID: NCT06808360
Status: COMPLETED
Last Update Posted: 2025-02-05
First Post: 2025-01-28
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Supportive and Dignified Maternity Care in Public Health Facilities
Sponsor: Aga Khan University
Organization:

Study Overview

Official Title: Supportive and Dignified Maternity Care (SDMC) - Development and Feasibility Assessment of an Intervention Package for Public Health Systems
Status: COMPLETED
Status Verified Date: 2021-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: SDMC
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.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: