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Inclusive, Supportive and Dignified Maternity Care in Public Health Systems (SDMC)

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ClinicalTrials.gov Identifier: NCT05146518
Recruitment Status : Recruiting
First Posted : December 6, 2021
Last Update Posted : December 6, 2021
Aga Khan University
University of Karachi
Information provided by (Responsible Party):
Bilal Iqbal Avan, London School of Hygiene and Tropical Medicine

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.

Condition or disease Intervention/treatment Phase
Behavior Respect Behavioral: Supportive and Dignified Maternity Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 310 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Inclusive, Supportive and Dignified Maternity Care (SDMC) - Development and Feasibility Assessment of an Intervention Package for Public Health Systems
Actual Study Start Date : February 15, 2020
Estimated Primary Completion Date : December 10, 2021
Estimated Study Completion Date : December 10, 2021

Arm Intervention/treatment
Experimental: Single-arm, pre-post
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

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.

Primary Outcome Measures :
  1. Women's experiences of supportive and dignified maternity care [ Time Frame: Before intervention, and after six months of intervention implementation ]
    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.

Secondary Outcome Measures :
  1. Perception of service providers about feasibility of SDMC intervention [ Time Frame: After six months of intervention implementation ]
    Service providers will be interviewed (in-depth) about their experiences of training and implementation experiences. These interviews will be conducted after intervention.

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Postnatal women

Inclusion Criteria:

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

Exclusion Criteria:

  • Reside outside of the demarcated catchment area

Health facility staff

Inclusion Criteria:

  • Clinical and non-clinical staff working in maternity section of selected health facility
  • Gave informed consent

Exclusion Criteria:

  • Recently appointed at the health facility (< than 6 months)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05146518

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Contact: Bilal Iqbal Avan, PhD +44(0)2079272317 bilal.avan@lshtm.ac.uk
Contact: Waqas Hameed, M.Phil. +92 21 3486 4919 ext 4919 waqas.hameed@aku.edu

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Aga Khan University Recruiting
Karachi, Sindh, Pakistan
Contact: Zahid Soomro, MSc    +923072221033    zahid.soomro@aku.edu   
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Aga Khan University
University of Karachi
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Principal Investigator: Bilal Iqbal Avan, PhD London School of Hygiene and Tropical Medicine
Study Director: Waqas Hameed, M.Phil. Aga Khan University
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bilal Iqbal Avan, Associate Professor, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT05146518    
Other Study ID Numbers: ITCRZQ6511
MR/T003375/1 ( Other Grant/Funding Number: Medical Research Council, United Kingdom )
First Posted: December 6, 2021    Key Record Dates
Last Update Posted: December 6, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Study datasets for the Supportive and Dignified Maternity Care will be made available on LSHTM Data Compass, a research data repository operated by the London School of Hygiene and Tropical Medicine.
Supporting Materials: 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.
URL: https://datacompass.lshtm.ac.uk/id/eprint/1979/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bilal Iqbal Avan, London School of Hygiene and Tropical Medicine:
health system
intrapartum care
respectful maternity care
mental health