Inclusive, Supportive and Dignified Maternity Care in Public Health Systems

NCT05146518 | Unknown

• 2 other identifiers: ITCRZQ6511MR/T003375/1
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 1

Brief Summary

Mistreatment, discrimination, and poor psycho-social support during childbirth at health facilities are common in lower- and middle-income countries. Despite a policy directive from the World Health Organisation (WHO), no operational model exists that effectively demonstrates incorporation of these guidelines in routine facility-based maternity services. This early-phase implementation research aims to develop, implement, and test the feasibility of a service-delivery strategy to promote the culture of supportive and dignified maternity care (SDMC) at public health facilities. Guided by human-centred design approach, the implementation of this study will be divided into two phases: development of intervention, and implementing and testing feasibility. The service-delivery intervention will be co-created along with relevant stakeholders and informed by contextual evidence that is generated through formative research. It will include capacity-building of maternity teams, and the improvement of governance and accountability mechanisms within public health facilities. The technical content will be primarily based on WHO's intrapartum care guidelines and mental health Gap Action Programme (mhGAP) materials. A mixed-method, pre-post design will be used for feasibility assessment. The intervention will be implemented at six secondary-level healthcare facilities in two districts of southern Sindh, Pakistan. Data from multiple sources will be collected before, during and after the implementation of the intervention. We will assess the coverage of the intervention, understanding and attitude of maternity team, and implementation challenges faced. Additionally, we will also gather women's maternity experiences and psycho-social well-being that will also inform the success of the intervention. Evidence from this implementation research will enhance understanding of health systems challenges and opportunities around SDMC. A key output from this research will be the SDMC service-delivery package, comprising a comprehensive training package (on inclusive, supportive and dignified maternity care) and a field-tested strategy to ensure implementation of recommended practices in routine, facility-based maternity care. Adaptation, Implementation and evaluation of SDMC package in diverse setting will be way forward.

Conditions

Behavior; Respect

Keywords

health system; intrapartum care; respectful maternity care; mental health

Outcome Measures

Primary Outcomes (1)

• Women's experiences of supportive and dignified maternity care

  Women's experiences of SDMC will be assessed using a adapted standard tool on mistreatment. Information on this indicator will be collected twice (before and after the intervention). Women will be recruited at health facilities at the time of discharge and their experiences of SDMC will be gather at 42 day of postpartum. Similar, methodology will eb applied for post-intervention interviews.

  Before intervention, and after six months of intervention implementation

Secondary Outcomes (1)

• Perception of service providers about feasibility of SDMC intervention

  After six months of intervention implementation

Study Arms (1)

Single-arm, pre-post

EXPERIMENTAL

Maternity staff of health public health facilities will exposed to the intervention package (capacity building and systemic changes in the health facilities).

Behavioral: Supportive and Dignified Maternity Care

Interventions

Supportive and Dignified Maternity Care BEHAVIORAL

The core components of intervention would include: capacity-building of a typical maternity team comprising clinical staff (gynaecologists, doctors, nurses) and support staff (ward boys/porters and maids); collaborative care, a team-driven approach, led by gynaecologists (ward in-charge), attempts to integrate care and behaviour practices of staff according to the principles of measurement-guided care-plans, quality improvement and accountability, with a focus on meeting SDMC needs; staff and patient feedback: a complaints register will be maintained by designated staff; and brief exit interviews will elicit, and record, the degree to which care has been supportive and respectful; Accountability and governance (performance review): reports of non-respectful care will be discussed, and remedial actions decided, in periodic meetings. Note: Since it is a behavioural intervention being administered at health system level so LSHTM has exempted this study to have a sponsor.

Single-arm, pre-post

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Gave birth in study site (health facility) during data collection period
• Gave informed consent

You may not qualify if:

• Reside outside of the demarcated catchment area
• Health facility staff
• Clinical and non-clinical staff working in maternity section of selected health facility
• Gave informed consent
• Recently appointed at the health facility (\< than 6 months)

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• Aga Khan University: collaborator
• University of Karachi: collaborator

Study Sites (1)

Aga Khan University

Karachi, Sindh, Pakistan

RECRUITING

Related Publications (1)

• Avan BI, Hameed W, Khan B, Asim M, Saleem S, Siddiqi S. Inclusive, supportive and dignified maternity care (SDMC)-Development and feasibility assessment of an intervention package for public health systems: A study protocol. PLoS One. 2022 Feb 9;17(2):e0263635. doi: 10.1371/journal.pone.0263635. eCollection 2022.

  PMID: 35139119 DERIVED

Related Links

• Overview of the project

MeSH Terms

Conditions

Behavior; Psychological Well-Being

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Personal Satisfaction

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Bilal Iqbal Avan, PhD

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

• Waqas Hameed, M.Phil.

  Aga Khan University

  STUDY DIRECTOR

Central Study Contacts

Bilal Iqbal Avan, PhD

CONTACT

+44(0)2079272317; bilal.avan@lshtm.ac.uk

Waqas Hameed, M.Phil.

CONTACT

+92 21 3486 4919; waqas.hameed@aku.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: It will be 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.

Study Record Dates

• First Submitted: November 18, 2021
• First Posted: December 6, 2021
• Study Start: February 15, 2020
• Primary Completion: December 10, 2021
• Study Completion: December 10, 2021
• Last Updated: December 6, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Two years after the completion of study.
• Access Criteria: To protect participant confidentiality, the de-identified datasets are made available through a controlled access approach. Researchers wishing to access datasets will be asked to apply for access via the repository's data request form, providing information on the variables they wish to access and details of their analysis plan. The request will be sent to the study team (that performed the research and have greatest understanding of the data) and the LSHTM Research Data Manager (who acts as an independent advisor). If the data analysis can be performed in compliance with the study's ethical and legal requirements, the study team will produce a derived dataset that contains the requested variables and work with the applicant to help them to understand the data. If there remains a recognisable risk that the derived dataset contains potentially identifiable information, the applicant will be asked to sign a Data Sharing Agreement before being provided with the dataset.

Locations

PA (1)