NCT06808360

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
314

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 5, 2025

Completed
Last Updated

February 5, 2025

Status Verified

April 1, 2021

Enrollment Period

1.5 years

First QC Date

January 28, 2025

Last Update Submit

February 1, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

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

    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.

    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 (1)

  • Perception of service providers about feasibility of SDMC intervention

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

Study Arms (1)

Supportive and Dignified Maternity Care (SDMC)

EXPERIMENTAL

Maternity staff at six health facilities will be exposed to the intervention package. The intervention will be evaluated using a pre-post comparison design.

Behavioral: Supportive and Dignified Maternity Care

Interventions

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.

Supportive and Dignified Maternity Care (SDMC)

Eligibility Criteria

Age15 Years - 49 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Delivered in a study health facility during the data collection period.
  • Provided informed consent.

You may not qualify if:

  • Reside outside the demarcated catchment area.
  • Health Facility Staff
  • Employed at the study health facility.
  • Provided informed consent.
  • Recently appointed to the health facility (less than 6 months).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thatta Project Office

Thatta, Sindh, Pakistan

Location

MeSH Terms

Conditions

Health Behavior

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Bilal Iqbal Avan, PhD

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Instructor

Study Record Dates

First Submitted

January 28, 2025

First Posted

February 5, 2025

Study Start

October 1, 2019

Primary Completion

March 31, 2021

Study Completion

March 31, 2022

Last Updated

February 5, 2025

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

This is under discussion.

Locations