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Bohrenetal. Reprod Health (2021) 18:149
https://doi.org/10.1186/s12978-021-01162-3
STUDY PROTOCOL
Formative research todesign
animplementation strategy forapostpartum
hemorrhage initial response treatment bundle
(E-MOTIVE): study protocol
Meghan A. Bohren1*† , Fabiana Lorencatto2*† , Arri Coomarasamy3 , Fernando Althabe4 , Adam J. Devall3,
Cherrie Evans5, Olufemi T. Oladapo4 , David Lissauer6,7 , Shahinoor Akter1 , Gillian Forbes2 ,
Eleanor Thomas3, Hadiza Galadanci8, Zahida Qureshi9, Sue Fawcus10, G. Justus Hofmeyr11,12,13,
Fadhlun Alwy Al‑beity14 , Anuradhani Kasturiratne15 , Balachandran Kumarendran16 ,
Kristie‑Marie Mammoliti3, Joshua P. Vogel17 , Ioannis Gallos3 and Suellen Miller18
Abstract
Background: Postpartum hemorrhage (PPH) is the leading cause of maternal death worldwide. When PPH occurs,
early identification of bleeding and prompt management using evidence‑based guidelines, can avert most PPH‑
related severe morbidities and deaths. However, adherence to the World Health Organization recommended practices
remains a critical challenge. A potential solution to inefficient and inconsistent implementation of evidence‑based
practices is the application of a ‘clinical care bundle’ for PPH management. A clinical care bundle is a set of discrete,
evidence‑based interventions, administered concurrently, or in rapid succession, to every eligible person, along
with teamwork, communication, and cooperation. Once triggered, all bundle components must be delivered. The
E‑MOTIVE project aims to improve the detection and first response management of PPH through the implementa‑
tion of the “E‑MOTIVE” bundle, which consists of (1) Early PPH detection using a calibrated drape, (2) uterine Massage,
(3) Oxytocic drugs, (4) Tranexamic acid, (5) Intra Venous fluids, and (6) genital tract Examination and escalation when
necessary. The objective of this paper is to describe the protocol for the formative phase of the E‑MOTIVE project,
which aims to design an implementation strategy to support the uptake of this bundle into practice.
Methods: We will use behavior change and implementation science frameworks [e.g. capability, opportunity,
motivation and behavior (COM‑B) and theoretical domains framework (TDF)] to guide data collection and analysis, in
Kenya, Nigeria, South Africa, Sri Lanka, and Tanzania. There are four methodological components: qualitative inter‑
views; surveys; systematic reviews; and design workshops. We will triangulate findings across data sources, partici‑
pant groups, and countries to explore factors influencing current PPH detection and management, and potentially
influencing E‑MOTIVE bundle implementation. We will use these findings to develop potential strategies to improve
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Open Access
*Correspondence: meghan.bohren@unimelb.edu.au; f.lorencatto@ucl.ac.uk
†Meghan A. Bohren and Fabiana Lorencatto are joint first authors
1 Gender and Women’s Health Unit, Centre for Health Equity, University
of Melbourne School of Population and Global Health, 207 Bouverie St,
Carlton, VIC 3053, Australia
2 Centre for Behaviour Change, University College London, London, UK
Full list of author information is available at the end of the article
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Page 2 of 16
Bohrenetal. Reprod Health (2021) 18:149
Background
In low resource countries, every six minutes a woman in
the prime of her life, and often with small children, dies
from postpartum hemorrhage (PPH) [1]. PPH, defined as
a blood loss of 500mL or more following childbirth, is
the leading cause of maternal death worldwide, account-
ing for 27% of global maternal deaths and affecting 5% of
all live births [2, 3]. Women who survive PPH are also at
risk for severe maternal morbidities (organ dysfunctions)
and longer-term disabilities [4]. e most common cause
of PPH is uterine atony (inadequate contraction of the
uterus after birth), and PPH can also result from uterine
rupture, retained placental tissue, genital tract trauma
(vaginal or cervical lacerations), and maternal coagula-
tion disorders [5].
e World Health Organization (WHO) published
recommendations for the prevention and treatment of
PPH in 2012 to provide evidence-informed recommen-
dations for preventing and managing PPH [5]. When
PPH occurs, early identification of bleeding and prompt
management with evidence-based interventions can
avert most PPH-related severe morbidities and deaths
[5]. However, adherence to the WHO recommended
practices for PPH treatment remains a critical challenge
[6]. For example, data from several low- and middle-
income countries (LMICs) show that most women with
PPH do not receive life-saving treatment [7]. Analysis of
WHO ‘Carbetocin Hemorrhage Prevention’ (CHAM-
PION) trial data (29,645 women; 10 countries) shows
that only 26% (235/886) of women with a blood loss
between 500 and 600mL received a uterotonic drug for
PPH treatment [7]. Alarmingly, even with a blood loss of
1000–1100mL, only 70% (68/96) of women received a
uterotonic drug for the treatment of PPH [7]. Moreover,
data from over 100 hospitals in Nigeria, Tanzania, and
Kenya show that the real-world PPH detection rates are
low (Nigeria 2.2%, Tanzania 2.5%, and Kenya 1.8%) [8,
9]. ese facilities typically rely on visual estimation of
blood loss, widely recognized as inaccurate, and often
resulting in underestimation of volume of blood lost
[10] and thus detection of PPH.
implementation, which will be discussed and agreed with key stakeholders from each country in intervention design
workshops.
Discussion: This formative protocol outlines our strategy for the systematic development of the E‑MOTIVE imple‑
mentation strategy. This focus on implementation considers what it would take to support roll‑out and implementa‑
tion of the E‑MOTIVE bundle. Our approach therefore aims to maximize internal validity in the trial alongside future
scalability, and implementation of the E‑MOTIVE bundle in routine practice, if proven to be effective.
Trial registration: ClinicalTrials.gov: NCT04341662
Plain language summary
Excessive bleeding after birth is the leading cause of maternal death globally. The World Health Organization (WHO)
has recommended several treatment options for bleeding after birth. However, these treatments are not used regu‑
larly, or consistently for all women. A key underlying issue is that it is challenging for health workers to identify when
women are bleeding too much, because measuring the amount of blood loss is difficult.
Maternal health experts have proposed a new clinical ‘care bundle’ for caring for women with excessive bleeding
after birth. A care bundle is a way to group together multiple treatments (e.g. 3–5 treatments). These treatments are
then given to the woman at the same time, or one after another in quick succession, and supported by strategies to
improve teamwork, communication, and cooperation.
This is a research protocol for the preliminary phase of our study (“E‑MOTIVE”), which means that it is a description
of what we plan to do and how we plan to do it. The aim of our study is to develop a strategy for how we will test
whether the E‑MOTIVE bundle works through collaborative activities with midwives and doctors in five countries
(Kenya, Nigeria, South Africa, Sri Lanka, and Tanzania) to develop a strategy for how we will test whether the E‑MOTIVE
bundle works. We plan to do this by conducting interviews and surveys with midwives and doctors, and reviewing
other research conducted on PPH to understand what works in different settings. We will discuss our research find‑
ings in a workshop, with midwives and doctors in the study countries to co‑create a strategy that will work for them,
based on their needs and preferences.
Keywords: Maternal health, Postpartum hemorrhage, Obstetric hemorrhage, Care bundle, Formative research,
Maternal mortality, Behavior change, Implementation, Intervention development
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Bohrenetal. Reprod Health (2021) 18:149
is raises the question as to what factors are leading to
low adherence to PPH recommendations in clinical prac-
tice and how adherence could be increased to improve
evidence-based practices and quality of care. An impor-
tant shift in the current thinking is the development of
‘clinical care bundles’ for PPH management. Clinical care
bundles are sets of three to five discrete, evidence-based
interventions, which are to be administered concurrently
or in rapid succession to every person presenting with
a specific diagnosis, with the goal of standardizing and
expediting care [6]. Care bundles extend beyond deci-
sion-making algorithms or checklists, as care bundles
aim to improve clinical practice by integrating discrete
clinical interventions to be delivered together (concur-
rently or in rapid succession). Central to care bundles
are teamwork, communication, and cooperation, both
among healthcare workers and between healthcare work-
ers, women and their families [6, 11]. Bundle compliance
is considered achieved when all actions are completed
and recorded [6, 11].
In 2017, WHO facilitated a technical consultation
to develop two care bundles of clinical interventions
for PPH: the “first response to PPH bundle” and the
“response to refractory PPH bundle” [6]. e interven-
tions to be considered for inclusion had to have been
previously recommended by WHO in its PPH prevention
and management guidelines [5, 12]. e elements in the
first response to PPH bundle included uterotonics, intra-
venous fluids, tranexamic acid (TXA), and uterine mas-
sage. As with any clinical bundle, they are intended to be
introduced along with supportive elements of advocacy,
training, teamwork, communication, respectful care, and
use of best clinical practices [6].
ese supportive elements are critical components of
the bundle: an extensive body of implementation research
based in high income countries has identified that pas-
sive dissemination of new clinical guidelines, including
care bundles, alone is unlikely to result in improved qual-
ity of care [13]. Indeed, implementing a new guideline or
recommendations in practice will almost always require
someone to do something differently. is can involve
adopting an entirely new practice, replacing one prac-
tice with another, doing more or less of an existing prac-
tice, or discontinuing a practice altogether [14]. at is,
implementation almost always requires behavior change,
often in individual and collective behaviors of healthcare
providers, as well as at organization, service delivery, and
system levels [15]. Such behaviors are typically complex.
is is particularly true of implementing care bundles,
which typically involve multiple actors (e.g. healthcare
providers), working together to deliver and perform mul-
tiple clinical actions concurrently or in rapid succession
[16]. ese behaviors are likely to be influenced by an
equally complex set of interacting individual, socio-cul-
tural, and environmental influences. erefore, design-
ing interventions to change clinical practice and improve
implementation first requires understanding of the influ-
ences on current and desired behaviors in the context in
which they occur [15, 16].
Previous research exploring influences on implementa-
tion of care bundles identified barriers related to: staffing
levels, case acuity, lack of awareness, lack of self-efficacy,
inappropriate expectations, overloaded or inadequate
staff qualified to implement, lack of engagement of staff
or management, fear of added work of record keeping,
and fear of reprisals for not complying with bundle ele-
ments [17–19]. Conversely, factors supporting or ena-
bling implementation of bundles include: perceived
sustainability, positive, supportive leadership and cham-
pions of the bundle, resources, training, focus on quality
of care, teamwork, communication, and including bundle
compliance into routine record keeping [17, 18]. How-
ever, this evidence is primarily from high-income set-
tings and concerns implementation of care bundles for
other clinical areas (e.g. chronic obstructive pulmonary
disease, sepsis). ere is limited evidence regarding chal-
lenges to care bundle implementation in LMICs, particu-
larly in maternal health and emergency settings, which
could include factors such as lack of staff with appro-
priate competencies, lack of essential supplies including
medications and overburdened services.
The E‑MOTIVE study
e E-MOTIVE program of research aims to improve
the detection and first response management of PPH
through the implementation of a new care bundle called
“E-MOTIVE” (Fig. 1). e E-MOTIVE bundle consists
of (1) Early detection of postpartum hemorrhage using
an under-buttocks, calibrated blood collection drape,
(2) Massage of the woman’s uterus, (3) administration
of Oxytocic drugs, (4) administration of Tranexamic
acid, (5) administration of IntraVenous fluids, and (6)
Examination of the woman’s genital tract and escala-
tion when necessary. E-MOTIVE will take place in three
key phases: a formative phase, intervention phase, and
post-intervention phase (Fig.2). During the intervention
phase, a parallel cluster randomized trial with a baseline
control phase will take place, along with a mixed-meth-
ods process evaluation and cost effectiveness study. In
the post-intervention phase, if the E-MOTIVE bundle
is effective, clinical guidelines will be updated to reflect
new evidence. However, as noted previously, dissemina-
tion of the bundle alone is unlikely to result in change in
practice. erefore, alongside the bundle, the E-MOTIVE
program of research aims to develop, adapt, and evaluate
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Page 4 of 16
Bohrenetal. Reprod Health (2021) 18:149
an implementation strategy to support clinician behavior
change and uptake of the bundle in practice.
is is the focus of the formative phase (Phase 1) of
the E-MOTIVE program of research, and the focus of
this study protocol. E-MOTIVE Phase 1 intervention
development will use mixed-methods to understand
how PPH is currently managed in the study settings, and
the potential barriers and enablers to implementing the
E-MOTIVE bundle. is will provide a basis for design-
ing an implementation strategy with healthcare staff
at the study sites to support uptake and delivery of the
E-MOTIVE bundle during the trial and in wider prac-
tice. is will involve a series of workshops (described
below) between research staff and facility-based staff in
the countries.
We plan to use a mixed-methods approach in the form-
ative research (Fig.2). In line with best practice guidance
for designing and evaluating complex interventions [20],
the formative phase will incorporate theory-based inter-
vention development, followed by a small-scale pilot and
mixed-methods process evaluation to explore the fea-
sibility and acceptability of the intervention and imple-
mentation strategy and potential contextual modifiers.
is will enable iterative refinement of the implementa-
tion strategy ahead of the definitive trial in Phase 2. is
protocol focuses on describing the formative research. A
separate protocol will be published for the feasibility pilot
study, and the E-MOTIVE trial is registered at Clinical-
Trials.gov (NCT04341662).
Study conceptual frameworks
ere are many overlapping behavior change theories,
with limited guidance available for selecting amongst
potentially relevant theories [21]. us, there have been
efforts to synthesize behavior change theories into inte-
grated, overarching theoretical frameworks and mod-
els. One such model is the COM-B model [13] and the
associated eoretical Domains Framework (TDF) [22],
which posits that in order for a desired Behavior to occur
(i.e. clinical practice action), the individual must have the
Capability, Opportunity, and Motivation to do so (Fig.3)
[13]. Both frameworks synthesize numerous theories of
behavior change into a core set of domains (e.g. factors)
representing individual, socio-cultural and environmen-
tal influences on behavior. Capability involves factors
Fig. 1 The E‑MOTIVE care bundle
Fig. 2 Overview of the E‑MOTIVE research projects. The formative components of the project are outlined in this protocol. Subsequent publications
will outline the adaptive cycles, parallel cluster randomized trial, process evaluation and cost‑effectiveness. COM-B model of behavior change
referring to capability, opportunity, and motivation; IDIs in‑depth interviews, EtD evidence‑to‑decision frameworks, WHO World Health Organization
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Page 5 of 16
Bohrenetal. Reprod Health (2021) 18:149
such as knowledge, skills, decision making, attention, and
memory. Opportunity concerns how our environment
influences behavior, and includes environmental context
factors (e.g. time, access to necessary supplies, resources,
staffing, infrastructure) and social context (e.g. practice
norms, professional identity, team working, pressure,
support, role modelling). Motivation includes internal
processes that energize and direct behavior, and factors
such as priority, goals, perceived benefits, risk and conse-
quences, emotions, habit, incentives, and threat.
Both frameworks have been widely applied in imple-
mentation research to explore barriers and enablers
to changing clinical practice behaviors and improving
implementation across various clinical contexts (e.g.
improving implementation of sepsis care bundles and
blood transfusion practice) [15, 19, 23]. A benefit of
COM-B and the TDF is that they are mapped to two
associated behavioral science frameworks specify-
ing different types of intervention strategies. First, the
Behaviour Change Wheel [13] which specifies nine
broad intervention types (e.g. education, modelling,
incentivization, environmental restructuring). Second,
the Behaviour Change Technique Taxonomy, which
specifies 93 more granular techniques for changing
behavior (e.g. goal-setting, feedback, self-monitoring)
[24]. ere are published matrices pairing domains of
COM-B or TDF with interventions in the Behaviour
Change Wheel and taxonomy [25–27], thereby linking
influences on behavior to fit-for-purpose intervention
strategies that are likely to be relevant and effective in
addressing different types of barriers and enablers. is
provides a basis for guiding decision-making during
subsequent intervention design and supporting more
systematic, targeted and theory-based development of
implementation interventions.
In this study, we will therefore use COM-B and the
TDF as overarching frameworks to guide our data col-
lection and analysis when exploring influences on cur-
rent practice and implementation of the E-MOTIVE
bundle. Using the COM-B and the TDF, we have mapped
potential barriers to E-MOTIVE bundle implementation
based on the available literature on bundle implementa-
tion (Additional file1) [17–19], which we plan to iterate
throughout the formative research. We will also use the
domains from these frameworks to facilitate triangula-
tion and comparison of findings across data sources, par-
ticipants (i.e. healthcare professional roles), facilities, and
countries. We will consult the Behaviour Change Wheel
and taxonomy to identify potential implementation
strategies to address key barriers and enablers to chang-
ing PPH practice and improving implementation of the
E-MOTIVE bundle.
Fig. 3 Integrated study conceptual frameworks: COM‑B Model, Theoretical Domains Framework, Behavior Change Wheel [13]
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Bohrenetal. Reprod Health (2021) 18:149
Study objectives
e overall aim of the formative phase of the E-MOTIVE
project is to design an implementation strategy for the
E-MOTIVE bundle. is study protocol outlines the
formative research to support the development of the
E-MOTIVE implementation strategy. e specific objec-
tives of the formative phase are:
1. To understand the current clinical management of
PPH in the study facilities;
2. To explore PPH detection and management in
healthcare providers’ current practice, how detec-
tion and treatment may be improved, and poten-
tial barriers and enablers to implementation of the
E-MOTIVE intervention in their practice; and,
3. To identify and agree with stakeholders the imple-
mentation strategies to address identified influences
on practices for detecting and managing PPH, and
barriers and enablers to uptake of the E-MOTIVE
bundle.
Methods
Study design andsites
is study protocol outlines the mixed-methods forma-
tive phase research activities (Table1). Given that find-
ings from the formative phase will influence the design
and implementation of the E-MOTIVE trial, this study
protocol only describes the formative work. ere are
four methodological components of the formative phase:
1. Qualitative research (in-depth interviews (IDIs);
2. Quantitative survey;
3. Systematic reviews; and
4. Stakeholder consultation and design workshops.
e formative study will take place in five countries:
Kenya, Nigeria, South Africa, Sri Lanka and Tanza-
nia. Table2 presents an overview of the country’s bur-
den of PPH. In line with the Medical Research Council
Guidance for Process Evaluations [28], we will balance
in-depth qualitative data collection in a sub-sample of
three countries, with broader quantitative data collection
across all five countries.
Qualitative research methods
Study sites andparticipants
is qualitative IDI study will be conducted in a purpo-
sive sample of three health facilities per country across
three countries (Kenya, Nigeria, South Africa), for a total
of nine health facilities. ese health facilities have all
met the inclusion criteria for the E-MOTIVE trial, and
thus are representative of the types of health facilities
participating in the trial. e health facilities included as
formative research sites will be excluded from participa-
tion in the clinical trial, as they may have been primed or
biased as a result of taking part in the formative research.
e health facilities to be included as sites in the quali-
tative study will be selected using maximum variation
sampling to ensure variation in the size of the facility,
location, representativeness of facility characteristics eli-
gible for main trial, and other key variables.
Healthcare providers currently working on the mater-
nity wards will be included as participants. is includes
midwives, nurses, junior doctors, non-physician clini-
cians, medical officers, residents or trainees, and obstetri-
cians. Healthcare administrators and managers in charge
of the maternity wards or health facilities will be included
as participants. is may include the head of obstetrics,
matron-in-charge, or medical or clinical director. All par-
ticipants will be capable of responding to the interview
questions in English.
Participant sampling andrecruitment
In line with qualitative sample size guidelines based on
principles of thematic data saturation [29], we will aim
to recruit an initial sample of ten to fifteen participants
per country across the three countries (n = a total of 45
participants: n = 15 participants per country, n = 5 par-
ticipants per health facility). We will analyze data in par-
allel with data collection, monitoring for thematic data
saturation as we go, and adjust the sample size as neces-
sary (e.g. discontinuing further interviews if saturation is
deemed achieved, or conducting additional interviews as
needed until saturation is deemed achieved). Maximum
variation sampling will be used to achieve a stratified
sample without random selection and to ensure hetero-
geneity of research participants. is method uses pre-
specified variables to stratify the sample and encourages
the recruitment and sampling based on diversity. In each
of the selected health facilities, healthcare providers will
be sampled based on their cadre, such as nurse, midwife
or doctor. e country investigators and research teams
will facilitate contact with potentially eligible healthcare
providers and administrators at their place of work in the
study health facilities. Each individual will be provided
with an information sheet about the study, invited to par-
ticipate by the research team, and if they agree, asked to
provide consent.
Study instruments
We have designed interview topic guides and surveys
based on COM-B and the TDF to explore factors influ-
encing current detection and management of PPH, by
ensuring we have at least one question per domain of the
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Bohrenetal. Reprod Health (2021) 18:149
Table 1 Formative research methods and data sources
Method Research question Data generated Sites Participants and
sampling Analysis methods Forms required
Qualitative research (IDIs) How is primary PPH during
vaginal birth (a) currently
detected and managed;
and (b) to what extent
are the E‑MOTIVE bundle
components imple‑
mented?
What are the factors influ‑
encing (a) current PPH
detection and manage‑
ment; (b) implementa‑
tion of the E‑MOTIVE
bundle?
Audio recordings
Written transcriptions with
field notes
n = 9 facilities total
n = 3 per country:
Kenya
Nigeria
South Africa
n = 45 providers total
purposively sampled:
Per country (n = 15):
3 administrators
6 doctors
6 midwives/nurses
Framework analysis using
combined deductive
framework and inductive
thematic analysis
Information sheet
Consent form
In‑depth interview guide
Online Survey How is primary and
refractory PPH during
vaginal birth (a) currently
detected and managed;
and (b) to what extent
are the E‑MOTIVE bundle
components imple‑
mented?
What are the factors influ‑
encing (a) current PPH
detection and manage‑
ment; (b) implementa‑
tion of the E‑MOTIVE
bundle
Electronic survey data n = 80 health facilities total
Kenya
Nigeria
South Africa
Sri Lanka
Tanzania
n = 630–700 healthcare
providers total
Per facility (n = 9–10)
1–2 obstetricians
3 medical officers/ resi‑
dents/junior doctors
5 midwives/nurses
Descriptive statistics
Content analysis (open
ended questions)
Information sheet
Consent form
Survey questionnaire
Stakeholder consultation
and design workshops What are the common and
unique factors influenc‑
ing PPH detection and
management across (a)
data sources [qualita‑
tive and survey]; and (b)
countries/sites?
To what extent is the
proposed E‑MOTIVE
implementation strategy
feasible and acceptable
to key stakeholders?
How might the proposed
strategy be adapted to
the local context in each
country?
Audio recordings
Written transcriptions with
field notes
Quantitative ranking exer‑
cise about feasibility and
acceptability
Stakeholder consultation
and design workshops
will be facilitated for each
country
E‑MOTIVE international
research team, E‑MOTIVE
country teams, hospital
representatives (doctors,
midwives)
Thematic analysis &
descriptive statistics Information sheet
Consent form
Ranking scales
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Page 8 of 16
Bohrenetal. Reprod Health (2021) 18:149
frameworks. e study instrument will be a semi-struc-
tured discussion guide (Additional file 2). is will be
structured according to three broad sections:
1. How PPH is currently detected and managed for vag-
inal birth;
2. Factors influencing current practice for PPH man-
agement. ese questions will be structured around
the domains of the COM-B model (capability, oppor-
tunity, motivation) [13]; and
3. Factors potentially influencing the implementation
of the E-MOTIVE bundle, structured around the
domains of the COM-B model.
e discussion guide has been developed by a team of
social and behavioral scientists, obstetricians, and mid-
wives to ensure clinical relevance and use of behavior
change theory. e IDIs will be piloted prior to data col-
lection, as part of training the research teams, and revi-
sions made to improve clarity.
Study procedures andfollow‑up
All IDIs will be conducted face-to-face, or via Zoom or
telephone (currently, COVID-19 restrictions do not allow
for face-to-face data collection outside of data collectors’
home institution), in English, and take place in a pri-
vate setting in the health facility where social distancing
Table 2 Burden of postpartum hemorrhage and current management in the E‑MOTIVE study sites
Global estimates indicate that between the years 2000 and 2017 global maternal deaths reduced by 35%, from 451 000 to 295,000 maternal deaths in
2017 [40]. During this 17 year period the global maternal mortality dropped by 2.9% on average each year. The global lifetime risk of maternal mortal‑
ity in 2017 was estimated at 1 in 190 [40]
Nigeria
Nigerian women have a 1 in 21 lifetime risk of maternal death, much higher than the global average. In 2017, 23% of global maternal deaths occurred
in Nigeria alone, with 67,000 reported maternal deaths. Nigeria had the fourth highest maternal mortality ratio (MMR) globally in 2017, with 917
deaths per 100,000 live births (Uncertainty Interval (UI) 658 to 1320). With an average Annual Reduction Rate (ARR) point estimate of less than 1.6%
(UI ‑0.8 to 3.5) between 2000 and 2017, Nigeria’s annual rate of reduction in maternal deaths per 100,000 live births dropped at a lower rate than the
global average during the same time period [40]. Results from a retrospective study of medical deaths in a tertiary institution in Northern Nigeria
indicated that PPH accounted for 14.2% of 112 maternal deaths during a five year period [41]. Further secondary analysis research concluded that
PPH was a significant contributor to obstetric hemorrhage and severe maternal outcomes in Nigerian hospitals. PPH occurred in 2.2% of births over a
1 year period, and was the most frequent obstetric complication across all facilities [9]
Tanzania
The United Republic of Tanzania reported approximately 11,000 (UI 8,100 to 14,000) maternal deaths in 2017, this was the fifth highest number of
maternal deaths worldwide. Women in Tanzania are estimated to have a 1 in 36 risk of maternal death. Figures indicate that in 2017, Tanzania was esti‑
mated to have an MMR of 524 deaths per 100,000 live births (UI 399 to 712), as well as an ARR point estimate of 2.9% (UI 0.9 to 4.4) between 2000 and
2017, in line with the global average [40]. Retrospective research from 34 public hospitals in Tanzania found that of the 1,987 maternal deaths over a
ten year period (2006–2015), 34% were due to eclampsia, followed by 24.6% due to obstetric hemorrhage. During this ten year period, the number
of maternal deaths increased, with MMR increasing from 40.24 in 2006 to 57.94 per 100, 000 live births in 2015 [42]. Further descriptive retrospective
tertiary research between 2003 and 2012 at a single center in Northern Tanzania reported an MMR of 492.1 per 100,000 live deliveries, in line with
previously reported WHO mortality estimates. Postpartum hemorrhage was found to be the leading cause of maternal death during the study period,
accounting for 19.2% of maternal mortality [43]
South Africa
Women in South Africa have a lifetime risk of maternal death of 1 in 330; this risk is lower than the estimated global average. In 2017, the number of
maternal deaths in South Africa was estimated to be approximately 1,400. During this year South Africa was estimated to have an MMR point of 119
deaths per 100,000 live births (UI 96 to 153), and an ARR point estimate of 1.7% (UI 0.1 to 3), indicating that the annual rate of reduction fell at a lower
rate than the global average between the years 2000 and 2017 [40]
The most recent Saving Mothers triennial report, by the National Committee for Confidential Enquiry into Maternal Deaths (NCCEMD) in South Africa,
gave obstetric hemorrhage as the cause of 624 or 16.9% of the total deaths between the years 2014 and 2017, making obstetric hemorrhage the
third most common cause of maternal death during this period, with 89.5% assessed to have been preventable by better care [44]
Kenya
Kenyan women have a 1 in 76 risk of maternal death during their lifetime, higher than the global average risk. In the year 2017, it was estimated that
5,000 maternal deaths occurred in Kenya, with an MMR point of 342 deaths per 100,000 live births (UI 253 to 476) during this period. Between the
years 2000 and 2017 the WHO estimated that Kenya had an ARR point of 4.3% (UI 2.4 to 5.9), indicating a lower rate of reduction in maternal deaths
than the global average during the same time period [40]. In 2017, the Kenyan Ministry of Heath produced their first Saving Mothers Lives report,
an enquiry into maternal deaths in Kenyan country and national referral hospitals during the year 2014. Obstetric hemorrhage was found to be the
underlying cause of 192, or 40% of the 945 maternal deaths during this period [45]
Sri Lanka
Sri Lankan women have a lifetime risk of maternal death of 1 in 1,300, and are at lower risk of death than the global average. In 2017, 120 maternal
deaths were reported in Sri Lanka. Figures estimate that in 2017, Sri Lanka had an MMR of 36 deaths per 100,000 live births (UI 31 to 41), as well as an
ARR point estimate of 2.2% (UI 1.7 to 3.5) between 2000 and 2017 [40]. This indicates that the annual rate of reduction in Sri Lanka dropped at a lower
rate than the global average over this 17‑year period. Data from the most recent National Maternal Mortality Review from the Family Health Bureau,
Ministry of Health Care and Nutrition of Sri Lanka reported that, in 2016 obstetric hemorrhage was the cause of 13.4% of maternal deaths in Sri Lanka,
and was the leading cause of maternal death during this period. More specifically, PPH was reported as the cause of death in 8 out of 112 (7.1%)
maternal deaths reported in Sri Lanka during this year (46)
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Page 9 of 16
Bohrenetal. Reprod Health (2021) 18:149
and hygienic behaviors can be maintained (or at home if
via Zoom or telephone), which is typical and appropri-
ate in each of the study settings. All interviews will be
digitally recorded on an encrypted device, and the inter-
viewer will take handwritten field notes containing both
descriptive information (settings, actions, behaviors) and
reflective information (thoughts, ideas, questions, con-
cerns) about the interview. At the start of the IDIs, par-
ticipants will be asked to confirm that they have received
the information sheet and signed the consent form. IDIs
are expected to last approximately 45–60min and will be
conducted by a trained research midwife or local social
science researcher.
Once the IDIs are conducted, the study participants
will not be followed up. e exception is if the partici-
pants in the qualitative study also participate in either
the quantitative survey or stakeholder consultation and
design workshops (described below). However, partici-
pation in the qualitative study will not be contingent on
participating in any subsequent research activities, and
responses will not be linked by participant or any identi-
fying information.
Data management andquality assurance
Prior to data collection, a multi-day training session will
be conducted for all the research teams, including coun-
try principal investigators, data collectors, and other
research team members. e training session will include
the study objectives, data collection procedures, practice
sessions with the tools, and ethical considerations. e
international research team and the principal investiga-
tors in each country, will train the research teams. is
training will take place via Zoom due to COVID-19 travel
restrictions. During the data collection period, the coun-
try principal investigators will be in consistent communi-
cation with the interviewers in the field to respond to any
issues that arise during data collection.
All digital recording will be transcribed verbatim into
English using a structured format. Transcription will be
done by either the data collector or a professional tran-
scription service that is General Data Protection Regu-
lation (GDPR) compliant. Verbatim transcription will
be performed close to the time of the completion of
the interviews to maintain the uniqueness of the inter-
view without loss of themes. Observations and assess-
ment during the interviews will be written up as field
notes and integrated into the transcripts. At the point
of transcription, data will be anonymized; no identifi-
able information about the participants will be included
in the written transcripts. Participants and sites will be
given identifying numbers for reference. Transcription
will occur in parallel to data collection and will be shared
on an on-going basis with the international research
team to ensure the quality of the data and to determine
if certain themes need to be further explored. e inter-
national research team will be responsible for reviewing
transcripts as they are shared in order to provide ongo-
ing feedback on topics that could be probed more deeply
during future interviews, identification of areas for
improvement, problem-solving, and facilitating dialogue
with the country teams regarding saturation of themes.
Data analysis plan
Anonymized transcripts will be analyzed using a com-
bined inductive thematic and deductive framework
analysis [30]. We plan to first use an inductive thematic
analysis approach [31] to allow themes to emerge natu-
rally from the data. en we will use a deductive frame-
work based on the study objectives and topic guide to
map the generated themes to key areas related to PPH
detection and management. Lastly, we plan to code the
emergent themes representing factors affecting imple-
mentation (barriers, facilitators, neutral responses) to the
domains of the underlying theoretical framework (COM-
B). We will deductively code the generated themes to
the relevant COM-B domain that they are judged to best
represent. For example, an instance of ‘lack of clear com-
munication and teamwork’ would be mapped to ‘social
Opportunity,’ ‘fear and stress managing PPH’ would be
mapped to ‘automatic Motivation’, and ‘lack of ready
access to oxytocin’ would be mapped to ‘physical Oppor-
tunity’. We expect that these themes will represent key
influences or factors affecting PPH detection and man-
agement, and the implementation of the E-MOTIVE trial
and design.
Quantitative survey design
Study sites andparticipants
is will be a cross-sectional, electronic survey con-
ducted in all E-MOTIVE study hospitals (n = 80) across
five countries: Kenya, Nigeria, South Africa, Sri Lanka,
and Tanzania. ese sites have been selected for partici-
pation in the E-MOTIVE trial, and will participate in the
survey, prior to the trial’s inception. We plan to engage a
variety of participants with the survey to gather a wide
range of opinions. All potential participants will cur-
rently work within the maternity wards of the study facil-
ities, including (but not limited to): midwives, nurses,
junior doctors, medical officers, residents, obstetricians,
and health managers. Potential participants must be
capable of reading and responding to the survey ques-
tions in English; there are no restrictions on other demo-
graphic characteristics of participants, including: age,
gender, race, ethnicity, or sexual orientation. Individuals
who are unable or unwilling to give informed consent
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Page 10 of 16
Bohrenetal. Reprod Health (2021) 18:149
to participate will not be able to take part, and patients
and family caregivers are not eligible to participate in this
survey.
Participant recruitment andsampling
e country principal investigators and facility research
coordinators will facilitate contact with the health care
providers and managers in each study facility. At each
health facility, the facility coordinator will obtain a list of
potential participants and their email addresses meeting
the eligibility criteria at their site. Individualized email
links to complete the survey will be sent to each eligible
participant, and reminders to complete the survey will
be sent weekly for two weeks. Participants will also be
invited to take part, if they have not already, at the study
sites, during site visits by the country principal investiga-
tors. We have chosen this method of recruitment in order
to be able to calculate response rates, understand the
denominator, and to facilitate monitoring of responses
and follow-up. Responses will not be able to be linked
back to an individual’s email address or name.
If participants are willing to take part, they will be
asked to provide written consent via the online survey
platform (SmartSurvey) before they begin. e first page
of the electronic survey will be the participant informa-
tion sheet. e second page of the electronic survey will
be the informed consent form, and a tick box to say ‘I
consent to all of the above statements’ or ‘I do not con-
sent to all of the above statements’ Participants will be
asked to complete the survey independently and in a set-
ting where they feel comfortable to give honest responses
without fear of repercussions.
Maximum variation sampling will be used to achieve a
stratified sample without random selection, and to ensure
heterogeneity of research participants. is method
uses pre-specified parameters to stratify the sample
and encourages the recruitment and sampling based on
diversity. In each of the 80 study facilities, healthcare
professionals will be sampled based on their cadre. We
expect the type or designation of health care profession-
als to vary by facility, but at the minimum would include
specialists, medical officers, and midwives/nurses. We
plan to sample nine to ten participants per study facility,
including five midwives or nurses, three medical officers
or junior doctors, and two obstetric specialists, for a total
of (n = 720–800) across all sites and countries.
Study instruments
e study instrument will be an online quantitative sur-
vey, hosted by SmartSurvey (Additional file3). e sur-
vey has been developed by a team of social and behavioral
scientists, obstetricians and midwives to ensure clinical
relevance and use of behavior change frameworks. e
survey will be piloted prior to data collection, as part
of training the research teams. e survey is expected
to take the participants approximately fifteen to twenty
minutes to complete. e overarching structure and con-
tent of the survey mirrors the qualitative interview guide
to facilitate triangulation between the two data collection
methods and data sources. e survey will cover the fol-
lowing domains:
1. Sociodemographic information (role, years of experi-
ence, country and place of employment);
2. How PPH is currently detected and managed for vag-
inal birth, including clinical vignettes or scenarios;
3. Factors influencing current practice for PPH man-
agement. ese questions will be structured around
the domains of the COM-B model (capability, oppor-
tunity, motivation) [13]; and
4. Potential barriers and enablers to implementing the
E-MOTIVE bundle, structured around the domains
of the COM-B model.
Response options will include a combination of dichot-
omous (yes/no or true/false), Likert scales, open-ended
short answer response, and multi-option format. e
survey will be made available in both a web and mobile
friendly format, to enable participants to take part on
their own devices with ease.
Study procedures andfollow‑up
Participants will be invited to take part in an electronic
survey study using a SmartSurvey web link. Participants
will be asked during the survey if they would like to hear
the results of the survey once they have been collated and
interpreted, and will be given the option to provide a con-
tact email if they so choose. If they choose to share their
contact email, their email address will be stored sepa-
rately from their survey responses to protect anonymity.
Once the surveys have been completed, study partici-
pants may have additional contact with the research team
through two potential avenues. First, if the participant
chooses to share their contact email, we will share the
study results with them. Second, if the participant is still
employed at the study site during the stakeholder con-
sultation and design workshops or the subsequent trial,
they may be involved in research workshops, developing
implementation strategies, etc. However, they will not
be identified as participants in the survey and their deci-
sion to participate or not in the survey will have no bear-
ing on their future involvement in the trial. When data
collection is complete, the data will be analyzed and the
results interpreted. ese findings will then be used to
inform the development of the E-MOTIVE implementa-
tion strategy.
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Bohrenetal. Reprod Health (2021) 18:149
Data management andquality assurance
All data collected through SmartSurvey is registered
under the General Data Protection Regulation 2018.
Secure Sockets Layer encryption will be added to any
survey, which enables an encrypted link between a web
server and a browser to be established. This ensures
that all data passed between the web servers and
the browsers remain private and integral. All data is
stored and backed up on United Kingdom-based serv-
ers, and will not be accessed nor shared without prior
permission.
Country PIs will be in frequent communication with
the E-MOTIVE formative research team in order to
respond to any issues that arise during data collec-
tion. Halfway through data collection in each country,
the E-MOTIVE formative study team will review all
data collected up to that point to ensure data quality.
Completion rates will be monitored, non-respondents
will receive a maximum of two reminder emails asking
them to complete the survey. Country principal investi-
gators will also follow up with study sites to maximize
response to the survey.
Data analysis plan
Once data collection is complete and results have been
exported from SmartSurvey, data will be cleaned and
prepared for analysis in Stata (StataCorp. 2019. Stata
Statistical Software: Release 16. College Station, TX:
StataCorp LLC). Any missing data or responses of ‘not
sure or other’ will be coded to allow this data to be
excluded from the analysis where appropriate. Quanti-
tative survey data will be summarized using descriptive
statistics as appropriate. Cross-tabulation will be used
to describe practices for PPH detection and manage-
ment, and perceptions of the E-MOTIVE intervention
for PPH management. Results will be cross-tabulated
and filtered to allow comparison of results by demo-
graphic subgroup, including job role, facility type or
level, and country. is data will help to establish a
benchmark or baseline of practices for PPH manage-
ment and perceptions of the E-MOTIVE intervention
and implementation strategy, to allow comparison
of practices and perceptions over the course of the
E-MOTIVE trial, and post-trial. For the theory-based
items exploring factors influencing PPH detection and
management, there will be at least two to three items
per domain of the COM-B model. To create a sub-scale
score for each domain of COM-B, we will calculate an
average response score across items corresponding to
that domain [32]. Open-ended or short answer ques-
tions will be analyzed using quantitative content analy-
sis [33].
Systematic reviews
In addition to the primary research outlined above, we
plan to conduct several systematic reviews during the
formative phase to inform the development of the imple-
mentation strategy. First, we plan to conduct a Cochrane
qualitative evidence synthesis (systematic review of
qualitative evidence) to describe and explore the percep-
tions and experiences of women, community members,
lay health workers, and skilled healthcare providers who
have experience with PPH, or with preventing, identify-
ing and managing PPH, in both community and health
facility settings [34]. is qualitative evidence synthe-
sis will supplement our primary qualitative research by
including the perspectives of women and communities,
and understanding the complexities of PPH detection
and management further upstream (e.g. for women giv-
ing birth at home, in the community, or in primary health
facilities). e Cochrane review protocol is published
elsewhere [34].
Stakeholder consultation anddesign workshops
Design of the E-MOTIVE bundle implementation strat-
egy based on the findings of the formative research will
involve two stages: (1) triangulation of findings across
data sources by the research team, and (2) stakeholder
consultation workshops to refine and adapt the strategy
to each country’s local context. e methods for each are
described below.
Research data triangulation
We are using multiple methods to collect data on factors
influencing PPH detection and management across coun-
tries, and from the perspective of different healthcare
professionals. It is therefore important to compare and
contrast the findings across these data sources and par-
ticipant groups using standardized triangulation meth-
ods [35, 36]. is will involve the E-MOTIVE research
team tabulating findings across data sources and looking
for areas of agreement, disagreement, and silence [35].
We will compare findings at three levels: (1) across data
sources (interviews vs. surveys vs. systematic review); (2)
across countries; (3) across healthcare professional roles
(e.g. nurses, midwives, doctors). is will help identify
areas for further discussion and clarification in the work-
shops (see Section: Stakeholder consultation and design
workshops below).
It will also inform decisions around components of
the implementation strategy that can be standardized/
shared across countries, versus those that need to be
tailored to each country and/or participant group. Find-
ings from the triangulation exercise will highlight key
influences on current practice and barriers and enablers
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Page 12 of 16
Bohrenetal. Reprod Health (2021) 18:149
to implementation, which represent potential targets for
implementation strategies. To generate potential recom-
mendations for strategies, we will consult the aforemen-
tioned tools that pair the COM-B and TDF frameworks
as part of the Behaviour Change Wheel to identify poten-
tial types of strategies that are likely to be relevant and
effective in addressing identified influences, and barriers
and enablers. We will generate descriptions of potential
strategies, to be presented and discussed at stakeholder
consultation workshops (see 5.3.2. below). Where pos-
sible, we will build upon existing strategies, such as the
Jhpiego “Bleeding after Birth” training package for PPH
management.
Stakeholder consultation anddesign workshops
We will then host country specific stakeholder consul-
tation and design workshops that bring together the
E-MOTIVE international research team and local col-
laborators. We have already identified a preliminary
implementation strategy based on the available evidence
on barriers and enablers to bundle implementation in the
broader literature (summarized and mapped to COM-B
in Additional file1). During the workshops, we will refine
the implementation strategy based on formative findings
specific to the study country and PPH contexts.
We anticipate that there will be a standardized set of
components (Fig.1). However, how these are delivered
and operationalized may be tailored and refined to each
country’s setting and specific influences on PPH detec-
tion and management. For example, all countries may
receive an element of standardized training, with tailor-
ing in terms of how the training is scheduled, which cadre
of healthcare workers attend the training, and how the
training is delivered. e workshops will be attended by
the E-MOTIVE international research team, E-MOTIVE
country teams, and hospital representatives (doctors,
midwives). Each participant will be given a study infor-
mation sheet and asked to sign a consent form prior to
participating in the stakeholder consultation and design
workshops. At present, it is planned that these workshops
will be held virtually, using platforms such as Zoom due
to COVID-19 restrictions. However, if safe and appropri-
ate, these may be held face-to-face in each country, or
using a hybrid model of Zoom and face-to-face.
e workshop will begin with the E-MOTIVE research
team presenting a summary of why PPH is a priority
issue to address, an overview of the broader EMOTIVE
program of research, and the proposed EMOTIVE bun-
dle. We will then briefly summarize the methods for the
formative research and the proposed implementation
strategies generated in the previous step. Each strategy
will be discussed in turn. For each strategy, we will first
outline what the proposed strategy entails, the evidence
from the broader literature supporting the strategy, and
relevant evidence from the formative research—spe-
cifically, what identified challenges (i.e. barriers and ena-
blers) the strategy aims to address. We will ask a series
of open and closed questions to participating stakehold-
ers to explore how acceptable and feasible the proposed
strategy is, as well as how the implementation strategy
could best be delivered, tailored, or adapted to their local
contexts. We will audio-record discussions for subse-
quent analysis. en the final agreed upon implementa-
tion strategy will be summarized using the “template for
intervention description and replication” (TIDieR) tem-
plate, a guideline for describing and reporting complex
interventions (e.g. TIDieR checklists; [37]).
Data generated from the workshops will include audio-
recordings, transcriptions, and field notes of the discus-
sions. Transcripts and field notes will be analyzed using
inductive thematic synthesis. ese findings will be used
to: (a) systematically and transparently report the inter-
vention development process; and (b) to finalize the
manual of operations for the trial, intervention materials
and protocols, including training.
Ethical considerations
We have received ethics approvals for this study (see
Declarations: Ethics approval and consent to participate
for list of approvals). e study will employ broad partici-
pation criteria to be as inclusive as possible of all cadres
of healthcare providers. erefore, specific sub-groups
of healthcare providers are not disadvantaged through
being unable to participate in the study. All potential par-
ticipants in both the qualitative and survey components
will receive information about the study in plain English,
conforming to ethical requirements for research involv-
ing human subjects. e language will be easy to under-
stand and free of technical jargons. Participants will be
given sufficient time to reflect on the information and ask
questions. ose who consent to participate in the study
will be requested to sign the informed consent form and
it will be made clear that they are free to withdraw from
the study at any stage without risk of any negative conse-
quences. All participants will be free to refuse to partici-
pate or stop participating at any time, confidentially, and
without prejudice. ere will be no form of deception in
this study.
In the qualitative interviews, the data collector
(research midwife and/or in-country social scientists)
will facilitate the informed consent process and the paper
(hard copy) signed consent forms will be maintained. In
the online survey, consent will be obtained via the online
platform. e contact details of the local investigators
including email address or telephone numbers will be
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Page 13 of 16
Bohrenetal. Reprod Health (2021) 18:149
made available to the participants in both the qualita-
tive and survey components, should they require further
information and assistance.
Study participants will not receive any compensation
for their participation. We expect that the qualitative
interviews will take place during their shift at work or
from home (if by telephone or Zoom), and they may be
provided with light refreshment (such as a cold bever-
age). Survey participants will not receive any remunera-
tion for their time.
Discussion
is formative study aims to collect information to
inform the design and implementation of a cluster ran-
domized controlled trial and process evaluation on PPH
early detection and primary response management,
which ultimately has the potential to reduce maternal
mortality and severe morbidity in some of the countries
with the highest PPH burden globally. Understanding
current clinical practice of detection and management of
postpartum hemorrhage will provide critical information
to ensure that the trial is not only feasible in the study
settings, but could be successfully implemented. Under-
standing potential barriers and enablers and involving the
facility health care professionals will help tailor and con-
textualize the Emotive Bundle implementation strategy.
Expected study outcomes
In this formative research, we aim to develop an imple-
mentation strategy for the E-MOTIVE bundle. e form-
ative research will provide deep understanding of current
clinical management practices of PPH, how detection
and management can be improved, and how implement-
ing the E-MOTIVE bundle can lead to improved practice.
Given the complexities of changing behaviors in order to
implement new guidelines and care bundles, using the
COM-B and TDF as guiding theoretical frameworks will
help us consider the broad range of potential influences
on implementation and identify the types of implemen-
tation strategies that are likely to be most relevant and
effective to target the key influences of appropriate PPH
detection and management and implementation of the
E-MOTIVE bundle. Moreover, by considering potential
barriers and enablers to implementation from the start of
the E-MOTIVE project, we expect to maximize the like-
lihood of a successful intervention, including real-world
applicability and effectiveness.
Strengthening international collaborations
e E-MOTIVE Research Group brings together a
diverse team of clinicians, multi-disciplinary researchers,
and implementation partners from the University of Bir-
mingham, WHO, University of California San Francisco,
University College London, University of Melbourne,
Jhpiego, Concept Foundation, Ammalife Charity, Uni-
versity of Liverpool, University of Nairobi, University
of Cape Town, University of the Witwatersrand, Bay-
ero University Kano, Nigeria, Muhimbili University of
Health and Allied Sciences and University of Kelaniya
and University of Jaffna. Each partner brings their own
unique expertise and perspectives to the E-MOTIVE
Research Group, and this expertise is diffused to the
other partners.
Main problems anticipated andproposed solutions
It is possible that healthcare providers and management
may not initially support the implementation of the
E-MOTIVE bundle in their workplace, and may there-
fore be reluctant to take part in research as they may
feel unable to express their concerns. However, the study
team will remind participants that their names will not
be linked to any responses and encourage the study par-
ticipants to uphold the confidentiality among their peers.
We will also remind participants that their decision
regarding whether or not to take part in the formative
research will not be shared with their peers or line man-
agers. Also, management teams (local champions) will
be established in each facility to ensure that top manage-
ment is aware and supportive of the research. e study
team will rely on the country partners and facility staff to
identify potential participants.
e E-MOTIVE formative study will be implemented
during COVID-19 times, meaning that additional pre-
cautions will need to be in place for both the research
team and participants. Depending on local conditions
and current restrictions, IDIs may take place over Zoom
or telephone instead of face-to-face. Where possible, the
local research team will minimize face-to-face contact
with each other and research participants.
Next steps followingformative phase
Following the stakeholder consultation and design work-
shops, we plan to field-test the feasibility of the provi-
sional E-MOTIVE implementation strategy, bundle, and
tools in two health facilities in each of the five countries
(ten health facilities total), over up to two adaptive cycles.
Each adaptive cycle will last approximately three months.
During the adaptive cycle, we will conduct a small-scale
mixed-methods process evaluation to explore two key
implementation outcomes [38] relevant to feasibility and
pilot studies, which need to be optimized before pro-
gressing to the full trial: fidelity (i.e. extent to which the
intervention is delivered and engaged with as intended)
and acceptability. Following the adaptive cycle, we will
convene a meeting with the multi-disciplinary research
team members and local clinical collaborators to agree
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Page 14 of 16
Bohrenetal. Reprod Health (2021) 18:149
which issues identified need to be addressed, and how
best to refine or add to the existing implementation
materials. If needed, we may progress to a second adap-
tive cycle to test the adapted implementation strategy,
and further discuss and adapt the intervention as needed.
e design of the implementation strategy, adaptive cycle
methodology, and results of the mini-process evaluation
will be described in subsequent publications.
Applicability anddissemination ofresults
e results of this formative research will inform the
design and implementation of the E-MOTIVE trial and
the process evaluation to be conducted in similar set-
tings. e qualitative and survey components will pro-
vide the initial interaction with providers similar to those
working in the study sites to better understand current
practice around detection and management of postpar-
tum hemorrhage. is evidence will then ensure that the
trial implementation plan is feasible, appropriate, and
applicable to the context.
We describe our systematic approach to formative
research, which considers potential barriers to imple-
mentation prior to the start of the E-MOTIVE trial. is
systematic approach enables us to design strategies to
improve implementation during the trial and beyond.
During the trial, this means we are maximizing the likeli-
hood of the interventions being delivered with fidelity If
healthcare providers do not use the bundle or if the bun-
dle is not implemented as intended, we have little or no
chance of testing the impact of the bundle on reducing
PPH-associated mortality and complications [39]. ere-
fore, a key implication of the formative phase is the oppor-
tunity to improve the internal validity of the E-MOTIVE
randomized clinical trial, noting its complexity (> 300,000
women across 80 health facilities in five countries).
Moreover, and in line with MRC guidance for devel-
oping and evaluating complex interventions [20], this
formative protocol outlines our strategy of consider-
ing implementation from the start of the E-MOTIVE
research program. is includes consideration of what
it would take to support roll-out and implementation of
the E-MOTIVE bundle in practice, rather than first eval-
uating the bundle in a trial context then thinking about
implementation afterwards. Our approach outlined in
this protocol therefore aims to maximize scalability and
implementation of the E-MOTIVE bundle in the future.
Findings from this formative study will be disseminated
to key stakeholders through a variety of outputs includ-
ing journal articles, presentations, and evidence briefs
as appropriate. Follow the E-MOTIVE study on Twitter
@EmotiveTrial.
Abbreviations
COM‑B: Model of behavior referring to capability, opportunity, and motivation;
GDPR: General Data Protection Regulation; IDI: In‑depth interview; LMIC: Low‑
and middle‑income countries; TIDieR: Template for intervention description
and replication; TDF: Theoretical domains framework ; TXA: Tranexamic acid;
PPH: Postpartum hemorrhage; WHO: World Health Organization.
Supplementary Information
The online version contains supplementary material available at https:// doi.
org/ 10. 1186/ s12978‑ 021‑ 01162‑3.
Additional le1. Mapping initial barriers to E‑MOTIVE bundle implemen‑
tation using COM‑B.
Additional le2. In‑depth interview guide: healthcare providers.
Additional le3. E‑MOTIVE formative survey.
Acknowledgements
The E‑MOTIVE Research Group includes: A. Metin Gülmezoglu (Concept Foun‑
dation, Geneva, Switzerland). Kristie‑Marie Mammoliti, Leanne Beeson, Becky
Timms (University of Birmingham, Birmingham, United Kingdom). Nigeria:
Faisal Saleh Dankishiya, Taiwo Amole, Aminu Ado Wakili, Muhammed Shittu,
Musa Baba (Africa Center of Excellence for Population Health and Policy,
Bayero University, Kano State, Nigeria). Kenya: Alfred Osoti, George Gwako
(Department of Obstetrics and Gynaecology, School of Medicine, University
of Nairobi, Nairobi, Kenya) Violet Nyambura Kimani (School of Public Health,
University of Nairobi, Nairobi, Kenya). South Africa: Mandisa Singata‑Madliki,
Joanne Batting (Effective Care Research Unit, University of the Witwatersrand/
Fort Hare, Eastern Cape Department of Health, East London, South Africa) Neil
Moran (Kwazulu‑Natal Department of Health, Durban, South Africa). Tanzania:
Beatrice Mwilike (School of Nursing, Muhimbili University of Health and Allied
Sciences), Emmy Metta (School of Public Health Sciences, Muhimbili University
of Health and Allied Sciences), Juma Makungu (Meatu District Hospital).
Authors’ contributions
Conceptualized and designed the study: AC, IG, FA, AD, OTO, DL, SM, FL, CE,
MAB, JPV; Drafted the formative research protocol: MAB, FL, SM, CE, SA, GF, and
ET, with input from all authors; Supporting study conduct and delivery: HG,
ZQ, SF, JH, FAA, AK, BK; Drafted this manuscript: MAB, FL, and SM, with input
from all authors. The manuscript represents the views of the named authors
only. All authors read, commented on and approved the final manuscript.
Funding
This work was supported, in whole or in part, by the Bill & Melinda Gates
Foundation [Grant Number: INV‑001393]. Under the grant conditions of the
Foundation, a Creative Commons Attribution 4.0 Generic License has already
been assigned to the Author Accepted Manuscript version that might arise
from this submission. The funders had no role in the study design, data collec‑
tion and analysis, decision to publish, or preparation of the manuscript.
Availability of data and materials
Not applicable.
Declarations
Ethics approval and consent to participate
This study has received or sought ethics approval from the following entities:
United Kingdom: University of Birmingham STEM committee (Reference
number: ERN_19‑1557). Australia: University of Melbourne Medicine and
Dentistry Human Ethics Sub‑Committee (1956004). World Health Organiza‑
tion: Review Panel on Research Project Review Panel s (RP2), WHO Ethical
Review Research Ethics Review Committee (WHO ERC; reference number:
ERC.0003486). Nigeria: National Health Research Ethics Committee of Nigeria
(NHREC) (Reference number: NHREC/01/01/2007)‑07/04/2020). Kenya: Uni‑
versity of Nairobi: KNH‑UON ERC (P25/01/2020); Pharmacy and Poisons Board
PPB/ECCT/20/06/06/2020(116), National Commission for Science, Technology
and Innovation Nacosti P/21/8437. South Africa: Eastern Cape Department
Content courtesy of Springer Nature, terms of use apply. Rights reserved.
Page 15 of 16
Bohrenetal. Reprod Health (2021) 18:149
of Health (EC_202007_015); University of Cape Town Human Research
Ethics Committee (HREC; reference number: 091/2020), Health Province of
KwaZulu‑Natal (NHRD reference number: KZ_202008_036), University of the
Witwatersrand Human Research Ethics Committee‑Medical (reference num‑
ber: M200241). Tanzania: Muhimbili University of Health and Allied Sciences
(MUHAS) (reference number: DA.282./298/01.C/); National Institute for Medical
Research (NIMR) (Reference number: NIMR/HQ/R.8a/Vol IX/3501). Sri Lanka:
Ethics Review Committee of Faculty of Medicine, University of Kelaniya.
Consent for publication.
Not applicable.
Competing interests
Professor Suellen Miller’s University (University of California San Francisco)
holds the license for the Trademark name “LifeWrap.” The LifeWrap is the name
of one first‑aid device used in refractory postpartum hemorrhage, the Non‑
pneumatic Anti‑Shock Garment (NASG). The manufacturer of the LifeWrap
NASG pays the University of California a royalty for the use of the name. Profes‑
sor Justus Hofmeyr has conceived a re‑usable device for postpartum blood
loss monitoring, the ‘Safe Birth Tray’, which is under development by Equalize
Health, a non‑profit global health organization who hold the intellectual prop‑
erty. JH may in future benefit from sales of the device. The remaining authors
declare that they have no competing interests.
Author details
1 Gender and Women’s Health Unit, Centre for Health Equity, University of Mel‑
bourne School of Population and Global Health, 207 Bouverie St, Carlton, VIC
3053, Australia. 2 Centre for Behaviour Change, University College London,
London, UK. 3 Tommy’s National Centre for Miscarriage Research, Institute
of Metabolism and Systems Research (IMSR), WHO Collaborating Centre
for Global Women’s Health Research, University of Birmingham, Mindelsohn
Way, Edgbaston, Birmingham B15 2TG, UK. 4 Department of Sexual and Repro‑
ductive Health and Research, UNDP/UNFPA/UNICEF/WHO/World Bank Special
Programme of Research, Development and Research Training in Human
Reproduction (HRP), World Health Organization, Avenue Appia 20, Geneva,
Switzerland. 5 Maternal & Newborn Health Unit, Technical Leadership Office,
Jhpiego, Johns Hopkins University, 1615 Thames Street, Baltimore, MD 21231,
USA. 6 Malawi‑Liverpool‑Wellcome Trust Research Institute, Queen Elizabeth
Central Hospital, College of Medicine, Blantyre, Malawi. 7 Institute of Life Course
and Medical Sciences, William Henry Duncan Building, University of Liverpool,
Liverpool, UK. 8 Africa Center of Excellence for Population Health and Policy,
Bayero University, Kano, Kano, Nigeria. 9 Department of Obstetrics and Gynae‑
cology, School of Medicine, University of Nairobi, Kenyatta National Hospital
Campus, Old Mbagathi Road, Nairobi, Kenya. 10 Department of Obstetrics
and Gynaecology, Grooteschuur Hospital, University of Cape Town, Floor H Old
Main Building, Anzio Road, Observatory, Cape Town, South Africa. 11 Depart‑
ment of Obstetrics and Gynaecology, University of Botswana, Notwane Rd,
Gaborone, Botswana. 12 University of the Witwatersrand, Amalinda Drive,
East London, South Africa. 13 Walter Sisulu University, Amalinda Drive, East
London, South Africa. 14 Depar tment of Obstetrics and Gynecology, Muhimbili
University of Health and Allied Sciences, United Nation Road, Upanga, Dar es
Salaam, Tanzania. 15 Department of Public Health, Faculty of Medicine, Univer‑
sity of Kelaniya, 6, Thalagolla Road, Ragama 11010, Sri Lanka. 16 Department
of Community and Family Medicine, Faculty of Medicine, University of Jaffna,
Adiyapatham Road, Kokkuvil, Sri Lanka. 17 Maternal, Child and Adolescent
Health Program, Burnet Institute, 85 Commercial Rd, Melbourne, VIC 3004,
Australia. 18 Depar tment of Obstetrics, Gynecology and Reproductive Sciences,
School of Medicine, Bixby Center, Safe Motherhood Program, University
of California, San Francisco, 550 16th Street, San Francisco, CA 94158, USA.
Received: 8 April 2021 Accepted: 17 May 2021
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