Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05146518 |
| Other study ID # |
ITCRZQ6511 |
| Secondary ID |
MR/T003375/1 |
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 15, 2020 |
| Est. completion date |
December 10, 2021 |
Study information
| Verified date |
December 2021 |
| Source |
London School of Hygiene and Tropical Medicine |
| Contact |
Bilal Iqbal Avan, PhD |
| Phone |
+44(0)2079272317 |
| Email |
bilal.avan[@]lshtm.ac.uk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Objectives:
Design a contextually-informed (or evidence-based) service-delivery model through a
participatory, consensus-driven process for inclusive, supportive and dignified maternity
care; and Implement and test the feasibility of the intervention model for its content and
operationalisation in public health facilities
Study phases:
Implementation phases:
The implementation of this study will be divided into two phases: (1) Development of
intervention: grounded in formative research around supportive and dignified care,
participatory approach will be used to co-create service-delivery intervention package; and
(2) Implementing and testing feasibility: a two-level feasibility assessment will be carried
out - health systems and staff assessment, and women's experiences around SDMC.
We will use the framework of human-centred design (HCD) to guide implementation of this study
(see figure 3). Human-centred design is an emerging concept and being used increasingly in
global health . The approach is classified in three phases: inspiration, ideation, and
implementation and testing.
Objective 1 - Design a contextually informed (or evidence-based) service-delivery model
through a participatory, consensus-driven process for inclusive, supportive and dignified
maternity care:
Phase 1: Inspiration:
The first step is 'empathise' - whereby, through a formative research we will understand
prevalent behaviours, challenges and opportunities around SDMC. It will be supplemented by
review of national and international guidelines, and best practices around the topic in
focus. We will begin with the participatory approach to engage with key stakeholders,
including practitioners, programme managers, policy makers, and community representatives to
ensure contribution and ownership of the project.
Formative research:
Focus Group Discussions (FGDs):
A total of five to eight FGDs will be conducted with postpartum women who have delivered in
public health facility during the last three months. These women will be identified from a
list frame to be obtained from the selected health facility. The FGDs will broadly explore:
(a) attitudes towards facility-based births; (b) motivations to give birth at the facility;
(c) expectations regarding maternity care; and (d) perceived quality of care with according
to the Hulton framework for quality of care in maternity services . The framework focuses on
both 'provision of care' and 'experience of care' (human and physical resources, cognitive
support, respect and dignity, equity, emotional support). A trained
sociologist/anthropologist will conduct FGDs who will be accompanied by note-taker. Informed
consent will be taken from participants of FGDs and all discussions will be audio-recorded.
The data generated from FGD will inform development of SDMC intervention package and
contextualised structured tools to assess experiences of SDMC at healthcare facilities.
Health facility assessment:
The assessment of health facility will comprise of: a) interviews with health system staff
(clinical and non-clinical service providers and administrators), b) review of management
information system, and c) observation of client-provider interactions.
• Indepth interviews (IDIs) with staff: IDIs will be conducted with clinical and non-clinical
maternity staff and administrators to broadly understand challenges and opportunities around
SDMC. The COM-B behavioural framework will guide the the development of interview guide and
data synthesis to understand individual and systemic factors around motivation, capabilities
and opportunities for supportive and dignified maternity care.
Observations:
• Review of management information system (MIS): We will review the kind of information
documented on inpatient records and assess mechanisms to use this data to make informed
decisions. Understanding MIS will enable the investigators to create or strenthen mechanism
for record keeping on incidents of any mistreatment as a measure of accountability.
Review of relevant national and international material:
We will conduct a thorough review of existing national and international material that is
pertinent to the supportive and dignified maternity care. This would broadly include:
existing national service delivery guidelines for maternity care during labour and
childbirth; WHO recommendations for intrapartum care; mhGAP material for neurological
disorders and substance abuse; existing training material on respectful maternity care.
Phase 2: Ideation:
In second phase, data synthesis will generate numerous issues and their possible solutions
around supportive and dignified maternity care. These solutions/ideas will then be discussed
with stakeholders to select the ones that are most relevant and applicable in the given
context, around which the prototype will be formally developed. The prototype will undergo
provisional testing through a collective review with stakeholders - who will reflect on its
relevance and operational feasibility in their routine practice.
Objective 2: Implement and test the feasibility of the intervention model for its content and
operationalisation in public health facilities
Phase 3: Implementation and testing:
The third phase of HCD fall within the scope of second study objective. In phase three, the
finalisation of prototype will be followed by pilot testing in real-life settings over a
period of three months. It is important to note that this implementation is will be
considered pilot as the field learnings will be fed back into design of intervention package.
Evaluation design:
A mixed-method, pre-post design will be used to test feasibility of the intervention
prototype.
Study settings:
The study will be implemented at six public health facilities - with three facilities in each
Thatta and Sujawal districts of southern Sindh province, Pakistan. These contagious districts
are located approximately 100 kilometres away from megacity, Karachi.
Study population:
The primary target-audiences will be women in childbirth and service providers (clinical and
non-clinical staff) of the labour room / maternity wards.
Health system and staff assessments:
Quantitative methods:
Baseline assessment will follow the capacity-building of clinical and support staff of the
health facility in training modules. The maternity team will receive comprehensive 3-day
training on SDMC that is tailored to their contextual settings. Senior staff members will
become master trainers, responsible for providing supportive supervision to ensure adherence
to set standards. Feedback from staff will be sought during the training about the relevance
of content and its implementation feasibility.
The knowledge and attitude of training participants (clinical and non-clinical staff and
administrators) regarding SDMC will be assessed through pre-and post-training tests. The
tools will be developed in accordance with the intervention package, after it is finalised.
Qualitative methods:
During the intervention period quality audits (or supportive supervision visits) will be
routinely conducted on all selected health facilities to assess adoption of, and adherence
to, quality standards through observation of women-provider interactions, staff coordination,
and facility assessments. The maternity staff will be provided with customised feedback based
on the observation findings.
Post-intervention, in-depth interviews will be conducted with practioners and programme
managers to explore intervention fidelity, dose and coverage, penetration of SDMC practices
across cadre, and individual, interpersonal, and system-level facilitators and barriers that
were encountered during delivery of the intervention in routine practice. We will also gather
their suggestions for improvement in the SDMC intervention package.
Women's experiences:
Quantitative methods:
Pre-post intervention assessments will gather information on women's experiences of SDMC at
health facilities, and suffering of postpartum depression within 42 days of childbirth.
Unlike health system assessment, two independent group of women will be enrolled in baseline
and endline. Recently published structured questionnaire on mistreatment during childbirth
will be contextually adapted and used for these pre-post assessments . Postpartum depression
and anxiety will be assessed using Patient Health Questionnaire - 9 and Generalised Anxiety
Disorder - 7, respectively.
Sample size calculation:
A total of 308 postpartum women will be required to detect a statistical difference of
2.5-units decrease (or 10% reduction) in the mean score of mistreatment (from 25 to 22.5)
with standard deviation of 6 , 90% power, 5% level of significance, 2 design effect, and 10%
lost-to-follow-up (LTFU) and/or non-response. We decided to proceed with a sample of 308 as
it gives sufficient precision to perform range of additional analysis such as estimation of
prevalence of different types of mistreatment and the effect of intervention on each of these
types of mistreatment, while will not negatively affecting study timelines.
Sampling strategy:
A convenience sampling technique will be used for the selection of study participants. All
women giving births at the selected hospitals during the data collection period will be
invited to participate in the survey, until the desired sample is achieved. During the
consent process, participants will be informed and asked whether they would be interested in
participating in a follow-up interview in their homes at six weeks of postpartum. Women who
showed interest in home-based interview and gave consent will be recruited in the survey.
Participants who lived outside of the study district or even in hard-to-reach rural areas of
the district will be excluded from this sample due to logistical constraints.
Data collection and management:
Standardised and contextually-adapted tools will be used in this study. All data collection
tools will be translated in the relevant local language and pre-tested in similar settings
prior to being used. Data collectors with prior experience will be hired and trained for
baseline and endline assessments, and routine audits. Indepth interviews (IDIs) and focus
group discussions (FGDs) will be conducted by trained sociologist and/or anthropologist. All
data collectors will receive a comprehensive and standardised training on both theoretical
and practical aspect of study instruments.
Qualitative interviews will be audio-recorded for later transcription and translation. All
quantitative data will be collected electronically on tablets. The software application,
developed in Epicollect5, will have built-in validation checks to minimize data collection
and entry errors. All software applications will be tested prior to their use in the study.
Unique IDs will be given to each study participant which will be consistent (where
applicable) in across assessments for synchronisation.
Data analysis:
Descriptive statistics will be used to describe the characteristics of study participants
such as age, level of education, socio-economic status etc. In order observed change in
women's experiences of SDMC, advanced statistical techniques will be used to estimate changes
in outcome indicators (SDMC experience) by means of multivariable linear (continuous) and
logistic (binary) regression models, accounting for intra-class correlation within health
facilities. We will create a composite score for women's experiences of SDMC which will
treated as outcome for pre-post comparison using linear regression. Depending on distribution
of the variable, we will consider dichotomising it to see pre-post intervention changes in
prevalence of SDMC experiences using logistic regression. Paired t-test (for continuous) and
McNemars test (for binary) will be used to observe change in knowledge and attitudes of
health facility staff before and after training. Stata version 16.1 (StataCorp LP, Texas,
United States) will be used for all analyses, and p-values of 0.05 will be considered
statistically significant.
For the qualitative enquires of formative research, we will use bottle-neck analysis approach
to identify prevalent issues that impedes provision of SDMC in health facilities, and also
determine the opportunties that can be leverage to promote SDMC. These findings will inform
the development of intervention package. The qualitative data to be collected
post-intervention, will be analysed to understand feasibility and acceptability of SDMC
intervention, and related barriers and facilitators of implementation. We will also analyse
suggestions of study participants to make improvements in the intervention package.
