Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2026-03-12 @ 12:54 AM
Study NCT ID:
NCT06808360
Status:
COMPLETED
Last Update Posted:
2025-02-05
First Post:
2025-01-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Supportive and Dignified Maternity Care in Public Health Facilities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015438', 'term': 'Health Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010166', 'term': 'Palliative Care'}], 'ancestors': [{'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 314}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-01', 'studyFirstSubmitDate': '2025-01-28', 'studyFirstSubmitQcDate': '2025-02-01', 'lastUpdatePostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Mean score of women's experiences of supportive and dignified maternity care", 'timeFrame': '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.', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Perception of service providers about feasibility of SDMC intervention', 'timeFrame': 'Endline assessment that will be done at the end of a six month intervention period. The assessment will be done in September-November 2021.', 'description': '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'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Behavior, Health']}, 'descriptionModule': {'briefSummary': "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.\n\nThis 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:\n\nParticipatory and co-created service-delivery intervention;\n\nCapacity-building of maternity teams (clinical and support staff) through a partnership approach;\n\nCollaborative Care Model;\n\nPatient orientation in the processes of care and their SDMC rights;\n\nInformation system (e.g., complaints register);\n\nAccountability mechanisms (e.g., exit interviews); and\n\nEmbedding performance reviews.\n\nUsing 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.\n\nEvidence 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.", 'detailedDescription': "Background:\n\nRespectful 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.\n\nGoal and Objectives:\n\nTo support inclusive Supportive and Dignified Maternity Care (SDMC) within health systems, particularly from the perspective of:\n\n1. The capacity of service providers, and\n2. Accountability and governance.\n\nThe specific objectives are to:\n\nASSESS: Health system challenges and opportunities for inclusive, supportive, and dignified intrapartum care.\n\nDESIGN: A service-delivery model through a participatory, consensus-driven process.\n\nTEST: The feasibility of the model for content and operationalization in health facilities.\n\nIntervention:\n\nThe components of the SDMC model include:\n\nCo-created implementation strategy;\n\nCapacity-building of maternity teams (clinical and support staff);\n\nCollaborative care;\n\nStaff and patient feedback; and\n\nAccountability and governance (performance review).\n\nMethods:\n\nThe 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.\n\nExpected Outcomes:\n\nA handbook for capacity-building of health facility staff to provide inclusive and dignified maternity care.\n\nAn adapted mhGAP manual for labor room staff to provide birthing women with psychosocial support.\n\nAn implementation strategy for embedding inclusive SDMC principles within public health systems.\n\nContextually adapted measurement tools for inclusive, supportive, and dignified care."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '49 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Postnatal Women\n\nInclusion Criteria:\n\nDelivered in a study health facility during the data collection period.\n\nProvided informed consent.\n\nExclusion Criteria:\n\nReside outside the demarcated catchment area.\n\nHealth Facility Staff\n\nInclusion Criteria:\n\nEmployed at the study health facility.\n\nProvided informed consent.\n\nExclusion Criteria:\n\nRecently appointed to the health facility (less than 6 months).'}, 'identificationModule': {'nctId': 'NCT06808360', 'acronym': 'SDMC', 'briefTitle': 'Supportive and Dignified Maternity Care in Public Health Facilities', 'organization': {'class': 'OTHER', 'fullName': 'Aga Khan University'}, 'officialTitle': 'Supportive and Dignified Maternity Care (SDMC) - Development and Feasibility Assessment of an Intervention Package for Public Health Systems', 'orgStudyIdInfo': {'id': 'Aku2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supportive and Dignified Maternity Care (SDMC)', 'description': 'Maternity staff at six health facilities will be exposed to the intervention package. The intervention will be evaluated using a pre-post comparison design.', 'interventionNames': ['Behavioral: Supportive and Dignified Maternity Care']}], 'interventions': [{'name': 'Supportive and Dignified Maternity Care', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Supportive and Dignified Maternity Care (SDMC)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Thatta', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'Thatta Project Office', 'geoPoint': {'lat': 24.74745, 'lon': 67.92353}}], 'overallOfficials': [{'name': 'Bilal Iqbal Avan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'London School of Hygiene and Tropical Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This is under discussion.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aga Khan University', 'class': 'OTHER'}, 'collaborators': [{'name': 'London School of Hygiene and Tropical Medicine', 'class': 'OTHER'}, {'name': 'University of Karachi', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Instructor', 'investigatorFullName': 'Waqas Hameed', 'investigatorAffiliation': 'Aga Khan University'}}}}