Behavior, HealthSDMCNCT06808360
Supportive and Dignified Maternity Care in Public Health Facilities
A study testing Supportive and Dignified Maternity Care in people with Behavior, Health, run by Aga Khan University at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 49 years
- Conditions the study is for
- Behavior, Health
- What is being tested?
- Supportive and Dignified Maternity Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2019to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Delivered in a study health facility during the data collection period.
- Provided informed consent.
- Employed at the study health facility.
- Provided informed consent.
Who cannot join
- Reside outside the demarcated catchment area.
- Health Facility Staff
- Recently appointed to the health facility (less than 6 months).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Supportive and Dignified Maternity Care (SDMC) - Development and Feasibility Assessment of an Intervention Package for Public Health Systems
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:
Read more
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.
Read the 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:
- 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.
- Conditions
- Behavior, Health
- Being tested
- Supportive and Dignified Maternity Care
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive and Dignified Maternity CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Supportive and Dignified Maternity Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: Endline assessment that will be done at the end of a six month intervention period. The assessment will be done in September-November 2021.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start1 Oct 2019
- Primary completion31 Mar 2021
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior, HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 314 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, University of Karachi
- Responsible party
- Principal investigator, Waqas Hameed, Aga Khan University
- Investigators
- Bilal Iqbal Avan, PhD, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06808360
- Sponsor's protocol ID
- Aku2020
- Acronym
- SDMC
- Status last verified
- Apr 2021
- First submitted
- 28 Jan 2025
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is under discussion.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supportive and Dignified Maternity Care (SDMC) - Development and Feasibility Assessment of an Intervention Package for Public Health Systems
- ClinicalTrials.gov ID
- NCT06808360
- Acronym / sponsor ID
- SDMC / Aku2020
- Conditions
- Behavior, Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, University of Karachi
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 5 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Supportive and Dignified Maternity Care (SDMC) | Experimental | Behavioral: Supportive and Dignified Maternity CareMaternity staff at six health facilities will be exposed to the intervention package. The intervention will be evaluated using a pre-post comparison design. |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Delivered in a study health facility during the data collection period.
- Provided informed consent.
- Employed at the study health facility.
- Provided informed consent.
Key exclusion criteria (3 listed)
- Reside outside the demarcated catchment area.
- Health Facility Staff
- Recently appointed to the health facility (less than 6 months).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supportive and Dignified Maternity CareSDMC 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. | Behavioural | Supportive and Dignified Maternity Care (SDMC) |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Individual participant dataSharing planned: No. This is under discussion.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bilal Iqbal Avan, PhD principal investigator
London School of Hygiene and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive and Dignified Maternity Care in people with Behavior, Health, run by Aga Khan University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.