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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||310 participants|
|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|
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.
- 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.
- 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.
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
|Contact: Bilal Iqbal Avan, PhD||+44(0)email@example.com|
|Contact: Waqas Hameed, M.Phil.||+92 21 3486 4919 ext firstname.lastname@example.org|
|Aga Khan University||Recruiting|
|Karachi, Sindh, Pakistan|
|Contact: Zahid Soomro, MSc +923072221033 email@example.com|
|Principal Investigator:||Bilal Iqbal Avan, PhD||London School of Hygiene and Tropical Medicine|
|Study Director:||Waqas Hameed, M.Phil.||Aga Khan University|