STRENGTHS AND LIMITATIONS OF THIS STUDY

This study was the first large-scale implementation research trial to examine the Ellavi uterine balloon tamponade (Ellavi) as a novel, free-flow, preassembled system for refractory postpartum haemorrhage (PPH) care.

Results from the implementation research showed that the training package and time saving, innovative design of the Ellavi facilitated its adoption, acceptability and feasibility.

A longer study duration would have fostered greater use-case observations as refractory PPH is a rare outcome and practitioners became more comfortable with the device over time; busy practitioners also requested shorter questionnaires.

Our article highlights the need for other studies to examine fidelity to training content during use and enable team simulations and individual practice prior to PPH events to increase user confidence.

The Ellavi is appropriate and feasible for use among obstetric staff working at different facility levels of care and can be successfully integrated into the Kenyan and Ghanaian maternal healthcare package.

Introduction

Postpartum haemorrhage (PPH) is defined by the WHO as a cumulative blood loss of at least 500 mL following vaginal birth, or 1000 mL following caesarean section, within 24 hours after birth.1 2 The most common cause of PPH is uterine atony, or failure of the uterus to contract after placenta delivery. Globally, PPH affects 5% of all deliveries, remains the leading cause of maternal mortality and morbidity, and is responsible for nearly 25% of all maternal pregnancy-related deaths.2 3 In Ghana, PPH is responsible for 22% of the direct obstetric deaths with a cause-specific case fatality rate of 1.3%.4 In Kenya, 49% of the maternal deaths are due to obstetric haemorrhage and half (49%) of those obstetric haemorrhage deaths are due to uterine atony.5 6

To treat PPH, WHO recommends a first-response bundle of interventions that includes administering uterotonics, isotonic crystalloids (intravenous fluids), tranexamic acid and uterine massage.7 Between 10% and 20% of PPH cases are refractory8 and are not responsive to these first-line interventions,9 and the patients continue to bleed. One-third to half of such refractory PPH cases are caused by uterine atony. Second-line bundles recommended for refractory PPH include a care package of interventions including aortic compression or bimanual uterine compression, uterine balloon tamponades (UBTs) and non-pneumatic anti-shock garments. Finally, invasive surgical procedures can be used, considering first those that preserve the uterus.7 10 11

UBTs for the management of refractory PPH have triggered much interest and debate over the past few years. Various commercially available UBT options exist, including volume-controlled UBTs such as the Bakri balloon, the ESM-UBT and the Ebb balloon, and pressure-controlled UBTs such as the Ellavi UBT. Multiple observational and prospective case series have documented and highlighted the effectiveness of UBTs in managing severe PPH.12–16 UBT success rates, ranging from 84% to 97%, have been reported with the different types of UBTs11 17–23 including volume-controlled UBTs such as the Bakri balloon and the ESM-UBT, and the pressure-controlled Ellavi UBT. Evidence suggests that UBT use is associated with a significant reduction in the rate of PPH-related invasive procedures such as artery ligation, uterine compression sutures, hysterectomy and arterial embolisation.24–26 The evidence on UBT efficacy and effectiveness from randomised studies in low-income and middle-income countries is conflicting. Results from a randomised controlled trial using UBTs conducted in Mali and Benin27 and a cluster randomised trial in Egypt, Senegal and Uganda,28 using prepackaged condom catheter UBT kits, showed unfavourable outcomes with higher rates of blood loss and maternal deaths for women who had UBT treatment. Although these studies had serious limitations, their findings have raised concern by suggesting that UBTs may not be as effective in managing refractory PPH as reported in observational studies and emphasised the need for rigorous evidence evaluating efficacy, safety, and the process of implementation.29

In 2021, WHO published a new recommendation on the use of UBTs for treatment of PPH due to uterine atony after vaginal birth in women who do not respond to first-line treatments.30 31 The recommendation further states that UBTs should be used only where access to other PPH treatments and supportive systems is already in place.

Alongside the need for establishing strong evidence of UBT efficacy through randomised controlled trials, we must also determine effective operational strategies for UBT use, especially in low-income and middle-income countries.32 To this end, we have conducted this multicountry implementation research study to identify the factors influencing uptake of the Ellavi UBT (a free flow-controlled system) by providers and facilities in Ghana and Kenya. By studying the adoption, fidelity, sustainability, appropriateness, acceptability and feasibility of Ellavi UBTs in six facilities, we aimed to inform future integration of the Ellavi UBT into national maternal healthcare packages.

Methods

This implementation study was guided by the Proctor et al Implementation Outcomes Framework.33 We aimed to examine adoption of the Ellavi UBT into facilities (percentage of facilities that incorporated the device in PPH management, percentage of hospital staff trained on Ellavi UBT), sustainability (sustained use) of the device over a 6 month period, PPH burden within the participating facilities and fidelity to the training. We also aimed to evaluate the factors determining appropriateness, acceptability and feasibility of using the Ellavi UBT among obstetric healthcare workers by exploring comprehension of the usage steps, accuracy of use, perceptions and attitudes toward the device, usability and user confidence, facilitators of use and barriers to use, use-patterns, and insights into training effectiveness.

Study design

This was a longitudinal, mixed-methods, implementation research study. We administered cross-sectional surveys to study participants immediately post-training (N=378) at baseline and then post-use (N=63) after refractory PPH treatment, over the following 10 months. We collected facility data on total births, PPH cases, PPH mortality and maternal mortality.

The post-training survey (see online supplemental Appendix 1) recorded information on comprehension of usage steps, feedback on the training methods used, perceptions and attitudes toward the device, usability and user confidence and appropriateness of the device for the context. The case management form (see online supplemental Appendix 2) and post-use survey (see online supplemental Appendix 3) were completed up to 24 and 72 hours after each PPH management experience; these tools examined staff experience and correct use of the device. One contact at each hospital was responsible for connecting staff to the PATH principal investigator after each PPH event to complete the study forms. Only one staff member was interviewed for each refractory PPH event, but teams of up to five staff worked together to resolve cases. This study was not powered to detect significance, only descriptive findings on implementation (process) outcomes and usability. Considering the local practicalities (eg, delivery rates, efficacy of first-line PPH interventions and the rarity of refractory PPH), we planned to observe a sample of 90 use-cases across both sites over the 10 months. However, thematic redundancy from qualitative usability data was expected to be achieved from a sample of 40.

Inclusion criteria

The study population included obstetric care workers (eg, obstetricians, medical officers, midwives and nurses) practicing at the six participating hospitals. All were encouraged to attend an Ellavi UBT training session and encouraged to use the device in practice. Only healthcare providers were included as study participants, and only if they signed a consent form to participate. If staff missed the training and managed a refractory PPH case, they filled out a consent form prior to completing surveys. Maternal PPH cases were not participants in this study.

Ellavi UBT device

The Ellavi UBT device is manufactured at the Sinapi Biomedical ISO-certified factory in Stellenbosch, South Africa. The preassembled device consists of a fillable water supply bag and a tube with a valve that connects the supply bag to the tamponade balloon (figure 1). The supply bag holds up to 1000 mL of water; indication levels are printed on the front and detailed, illustrated user instructions are printed on the back. The tubing displays height level markings that correspond to patient systolic blood pressure. Sinapi received a CE Mark for the device in 2019, and it was registered with the Kenya Pharmacy and Poisons Board and the Ghana Food and Drug Administration to treat refractory PPH by atony by 2020.

Figure 1

The Ellavi uterine balloon tamponade device and quick setup reference instructions.

Study sites

Three Kenyan hospitals (Kenyatta National Hospital (KNH), Mbagathi County Hospital (MCH) and St. Mary’s Mission Hospital (SMMH)) and three Ghanaian hospitals (Tema General Hospital, Kasoa Polyclinic, and Ridge Hospital) were purposively selected for this study based on their urban location, large catchment population and PPH burden, facility level representation and access to UBT master trainers. All six facilities follow national guidelines for the management of PPH, including use of second-line interventions for refractory PPH (including use of UBTs).

Training sessions (intervention)

In both countries, the trainings were held at the workplace, with attendance capped at 25 participants to maximise social distancing for COVID-19 prevention. Other COVID-19 protocols (facemasks, hand-washing, temperature checks) were strictly followed.

Training content included a review of refractory PPH management, application of the Ellavi UBT, an outline of the study objectives, onboarding criteria and tools, implementation guidance and study contacts. The Ellavi UBT use presentation included an instructional video from the manufacturer. Additionally, teams of learners practiced using the device with humanistic foam postpartum pelvic models in a simulated PPH event.

In Kenya, 15 trainings were conducted at SMMH (1 and 18 December 2020), MCH (9 March 2021 and 7 July 2021) and KNH (29 January 2021; 8, 10, 11 and 12 March 2021; 6–7 May 2021; 17–18 June 2021; 26–27 August 2021). The trainings were led by four obstetricians from the University of Nairobi Medical School and the KNH obstetrics/gynaecology department, with assistance from PATH. Ten trainings were offered in Ghana at Tema General Hospital (9–11 December 2020), Kasoa Polyclinic (18–20 November 2020) and Ridge Hospital (29 November 2020 to 2 December 2020). These trainings were led by an obstetrician and UBT expert, with assistance from PATH. For the purpose of this study, PATH purchased 500 Ellavi UBT units for the participating hospitals.

Patient and public involvement

Patients were involved in the conduct of this research since the Ellavi UBT is registered in both Ghana and Kenya and used as part of the standard maternal care package, where available, to treat refractory PPH. Study participants (obstetric ward staff) participated in conduct of the study but were not involved in the study design; they received the study results via dissemination events led by the local principal investigator working at their facility. The public was not involved in study design or conduct of the study, but public dissemination events were held in both Ghana and Kenya at local health conferences, national obstetrical gynaecological society meetings, and meetings with the Ministries of Health.

Data management and analysis

Paper survey data were entered into an Excel database on Box, a cloud-based content management system, and processed by Power Query. The study team back-checked 30% of data entry records to ensure accuracy. Simple frequency tables were generated to assess the quality of the data prior to statistical analysis in Stata V.12 (StataCorp, College Station, Texas, USA). Descriptive statistics were calculated in Stata to report on implementation outcomes and the qualitative data responses were coded in Excel to examine predominant themes. The data generated by our team of coauthors are publicly available on Figshare and were used in the writing of this article.34

IRB approvals

This study conformed to the principles embodied in the Declaration of Helsinki. This study was also registered with the Kenya Pharmacy and Poisons Board, Kenya’s National Commission for Science, Technology and Innovation and ClinicalTrials.gov.

ResultsPPH burden

Participating Kenyan and Ghanaian facilities oversaw 11 188 and 15 262 deliveries and managed 278 and 343 PPH events, respectively. Most PPH events were controlled using conventional management strategies. During the 7-month data collection period in Kenya and 10-month period in Ghana, at least 118 patients were referred for some surgical procedure (table 1). Of the 23 Kenyan refractory PPH cases reported during the study, the Ellavi UBT was deployed in 19 (93%) cases; 13 provided definitive management, 5 were resolved by surgical intervention and 1 was resolved by condom catheter (20-week miscarriage). In Ghana, the Ellavi UBT was deployed every time a refractory PPH case was reported to our staff (n=44); 38 provided definitive management, 4 were resolved surgically, 1 by condom catheter (case of uterine fibroids) and 1 was referred for specialised care.

Table 1

Facility-level data from the six participating hospitals

Ellavi UBT adoption

All six facilities adopted the Ellavi UBT (100% adoption), meaning facilities trained relevant providers and placed the devices in the labour wards, maternity wards, delivery rooms, operating theatres, postnatal wards and main stores for easy access during the study period (table 1). In Kenya, 52% of the 380 total obstetric staff were trained on the Ellavi UBT; trained staff primarily consisted of registrars (66%) and midwives or nurses (33%) (table 1). In Ghana, 62% of the 380 obstetric staff were trained and the majority were midwives (78%). All facilities (100%) used the Ellavi UBT to manage at least one refractory PPH case. Over the study period, at least 7% (14/215) of the trained providers in Kenya and 8% (19/236) in Ghana used the UBT to treat a refractory PPH case (only one staff was surveyed per obstetric care team and untrained staff could use the device).

Sustainability

A sizeable majority (83%) of the study facilities used the device at least once, 4 or more months after the training. Half (50%) of the facilities used an Ellavi UBT every month for six consecutive months.

Provider post-training perceptionsAppropriateness and acceptability of the Ellavi UBT

Following training, obstetric staff were asked what they most liked and disliked about the Ellavi UBT. Overall, the Kenyan staff (N=189) perceived the device to be an effective intervention for PPH management. Two-thirds appreciated its innovative design (65%), one-third remarked on its simplicity and ease of use (31%) and others liked its preassembled nature (14%), appropriateness for the context (14%), and user controls (eg, T-valve) (9%). Similarly, in Ghana, obstetric staff (N=184) appreciated its easy-to-use design (85%), durability (11%), ability to provide effective care (22%) and preassembled nature (28%), saving precious time to easily insert (15%) and provide patient care (22%). Appreciative quotes from obstetric staff included:

It’s preassembled. It’s effective and fast to use since everything is in one pack.

—Kenyan Nurse

The free flow system allows fluid movement, but it also has controls (T-valve) to adjust the intrauterine volume pressure to systolic BP.

—Kenyan Registrar

It’s safe in the hands of various levels of health providers.

—Ghanaian Registrar

It’s easy to assemble. No stress in tying the tubes with ligatures.

—Ghanaian Midwife

It’s easy to insert manually. It’s preassembled so it saves time.

—Ghanaian Physician’s assistant

When asked about dislikes, less than two-fifths (N=71) of the Kenyan staff gave responses. Of respondents, one-third voiced concerns about it requiring an adjustable drip stand (35%) and its sustainability beyond the project (14%); others disliked certain usability issues (40%) (eg, height calculation for supply bag) and the need for continued capacity-building (11%). Similarly, less than one-quarter (24%) of Ghanaian obstetric workers had dislikes. Among them, some (39%) expressed concerns about its perceived cost, and fewer expressed concerns for its single-use nature (5%), the need for adjustable drip stands (6%), inflexible tubing (5%), potential allergies (5%) and assistance requirement (5%). Quotes expressed by obstetric workers about the above concerns included:

Blood pressure—the height calculation of the bag above the patient is not straight forward, beds are adjustable. —Kenyan Registrar

If you don’t have an adjustable drip stand, the water won’t flow easily.

—Ghanaian Midwife

It needs an assistant so it will be very difficult to use if (you are) left alone.

—Ghanaian Midwife

[Myself, I] … need more practice before a real PPH event.

—Kenyan Midwife

Acceptability of the Ellavi UBT training

Over 80% of the trainees reported the Ellavi UBT was easy to use and many stated its clear advantages over condom catheters, the standard of care. Approximately 90% of the trainees said they could use the Ellavi UBT by themselves if required but typically PPH events were managed with a colleague (78%–83%) or in a team (2%–16%) of colleagues, rather than alone (10%) (table 2). Obstetric staff perceived the most effective training methods to have been the team drills practicing PPH treatment, use of foam models to simulate treatment and instructional videos. However, more than half (54%) reported wanting more time to practice using the device.

Table 2

Indicators of study participants’ understanding of use and attitudes toward the device post-training.

Provider post-use perceptionsAcceptability and feasibility of the Ellavi UBT device

Sixty-three cases were managed with Ellavi UBTs (19 in Kenya and 44 in Ghana) by 18 and 22 obstetric staff in Kenya and Ghana, respectively. Survey results were compared between post-training and post-use responses (table 3). Post-use, obstetric staff remained confident in their ability to correctly use an Ellavi UBT to manage PPH (100%) and most (>85%) had no requests for improvements to instructions for use (IFU). Kenyan users more commonly reported referring back to IFU (56% vs 2%) but were more likely to report that Ellavi was easy to use (94% vs 79%). Usability indicators (insertion, monitoring, removal) remained high (>71%) and need for the presence of a more technical person declined (<12%). Almost all users, post-use, maintained that they could use the Ellavi UBT alone, if needed (94%–95%). Users perceived simulation models (65%–88%) and practice exercises (53%–70%) with teammates to be the most effective training methods; some still desired more time practicing with the device (50%–64%) prior to patient care. Overall impressions of Ellavi UBT’s effectiveness was high (72%–92%) but decreased post-use among Kenyan obstetric staff and increased among Ghanaian staff.

Table 3

Observations in comprehension, attitudes, usability and user confidence, and insights into training effectiveness between users’ post-training and post-use scores

Experiences managing refractory PPH

Following the management of the included refractory PPH events, we assessed fidelity to the training and accuracy of use, accessibility of Ellavi UBT and other experiences of use (table 4). The Ellavi UBT was used by medical officers, registrars, midwives and nurses for both vaginal deliveries and caesarian sections. Most refractory PPH cases were caused by atony (88% in Ghana and 79% in Kenya). Oxytocin was used in all but one case along with other uterotonics (eg, misoprostol, carbetocin); intravenous fluids, uterine massage and tranexamic acid were also used as per training on the primary bundle. The Ellavi UBT is designed to be used between systolic blood pressures of 60 to 120; however, the device still controlled haemorrhage in 24 of the 29 cases with BP above 120. Devices were largely stored in the delivery room, maternity ward and operating theatres for easy access and inserted into patients within 1 hour of refractory PPH recognition. Obstetric staff felt encouraged by facility leaders and colleagues to use the Ellavi UBT.

Table 4

Fidelity to training: use patterns

Fidelity

Accuracy of use, according to training course instructions and initial height placement of the supply bag at the start of PPH management, was very high (94% Kenya and 100% Ghana) but adjustment of the supply bag’s height during treatment was low (61% Kenya and 54% Ghana). Trainees were instructed to remove the UBT after 30–60 min if unable to stop the haemorrhage; check for continued bleeding 6–8 hours after insertion and if bleeding recurs, hang the supply bag back at appropriate height up to a maximum of 24 hours. In Kenya, trainees were instructed to readjust every 15 min during the first hour, every 30 min during the second hour and hourly thereafter. In Ghana, these instructions were adapted based on feedback from midwife trainees; the modifications dictated positioning the bag 1.5 m above the patient and adjusting the height only if the patient had discomfort. On average, the device was inserted into the patient 1 hour after recognition of PPH in Ghana and Kenya (table 1). Among the patients for whom the Ellavi UBT did not stop the haemorrhage (32% Kenya and 9% Ghana), the device was removed about an hour after insertion in Kenya (50 min) and Ghana (44 min) but some unsuccessful use cases went as long as 2.8 hours. Successful use cases typically had the Ellavi UBT removed after 5.3 hours to 6.5 hours; about one-quarter (29% Ghana and 22% Kenya) had the UBT inserted for more than 8 hour; no staff allowed the device to be inserted for more than 24 hours.

Discussion

This study was conducted to examine implementation outcomes associated with introducing an improved device (the Ellavi UBT) to manage refractory PPH cases in Ghana and Kenya. It highlights the need to address gaps in understanding implementation challenges en route to improving treatment effectiveness.27 28 Implementation outcomes provide indicators of implementation success, proximal indicators of implementation processes and offer intermediate outcomes to consider in relation to service outcomes (eg, efficiency, safety, effectiveness, timeliness) and client outcomes (eg, satisfaction).33 Our study focused on implementation effectiveness, rather than clinical intervention effectiveness. This article highlights the need for researchers to examine training rates and fidelity to training content, as well as acceptability and feasibility, while building evidence around UBT efficacy within future interventions.

We observed moderate levels of adoption and sustainability over the 6 months of our study. All facilities adopted the Ellavi UBT device. The majority of the obstetrics staff participated in trainings and half of the facilities used the device at least once every month. Although we observed relatively few use-cases and a small percentage of providers who used the devices over the 6 months, these data reflect the rarity of refractory PPH events, the fact that only one team member was surveyed post each PPH event, and given our other indicators, does not reflect low provider motivation to use. In fact, Ellavi UBTs were used in the majority of refractory PPH cases, and providers reported it was appropriate and acceptable. The 2021 total PPH rate reported herein was similar to the 2020 total PPH rate reported from the year prior (data not presented). Our observed PPH rate may have been lower than the expected 5% rate because blood loss volumes were visually estimated within study facilities and thus likely underestimated due to poor measuring and documentation practices. To foster adoption and sustained used of new devices, we recommend identifying UBT champions and tasking them to promote use, conducting team simulation exercises during trainings, enabling more practice time with models prior to PPH events, strategically placing the device within facilities, ensuring trained providers are present on each shift and fostering interest and engagement among hospital leadership.

Given the complex and emergency nature of PPH cases, defining and observing correct use-cases for UBTs can be challenging. It is important to note that obstetric staff were able to stop all cases of severe PPH with an Ellavi UBT (among cases that did not require surgery) except for two which employed condom catheters. The staff feedback received from these cases indicated that the Ellavi UBT was too large for a second trimester miscarriage (small uterus) and too thick to be helpful with uterine fibroids. Further research is needed to determine if these conditions should be excluded from the future definition of appropriate use-cases, however, a constrictive ring can be added to reduce the Ellavi balloon size for smaller uteri. We assessed fidelity to specific training content indicators when using the Ellavi UBT via survey and not observation. Adjustment of the fluid bag was the component with the lowest fidelity. In our study, we introduced the Ellavi UBT at six sites by using a dynamic training programme that incorporated multiple learning methods.35 Future studies should explore additional strategies to improve both implementation and service outcomes for the UBT. For example, improvements in training rates, fidelity to learnt methods and sustained use may be achieved with pre-service and in-service curriculums incorporating UBT devices, facility-based mentorship programmes supporting individual UBT-use, group refresher trainings (especially at low-volume facilities or where staff turnover is high), high-fidelity team practice simulations prior to emergency situations, advocacy for UBT use by local champions and Ministry of Health supervisor visits to monitor use and storage.7 36–39 Both Ghana and Kenya have illustrated a strong commitment to equip health providers with the proper tools to strengthen skills via training and supportive mentorship.

Among the facility levels where we tested implementation, the Ellavi UBT appeared appropriate due to the high volume of deliveries and the need for all refractory PPH bundle components. The device was also highly accepted; post-training, the majority of providers praised the device and expressed a preference for the Ellavi UBT over condom catheters due to its preassembled design (which hastens the process to deliver critical care), ease of use, free flow system with T-valve, sterile packaging and perceived effectiveness of the device to treat PPH. Before the Ellavi UBT was introduced, only condom catheters were used as a non-surgical intervention. Post-training, obstetric staff instead consistently chose to use the Ellavi UBT and without financial incentives. Maxwell also found the Ellavi UBT was the preferred device among third-year and fourth-year students from Harvard Medical School in terms of simplicity, ease of use and speed to deploy when tested for usability against the ESM-UBT, an improvised condom balloon, Bakri balloon and Ebb balloon.40 Post-use, acceptability remained high and providers reported it was feasible to use in routine care. Most participants reported high usability and user confidence when using the device to treat severe PPH; they perceived the device could effectively treat severe PPH and was effective in comparison to other PPH treatments. The facilitators of acceptability and feasibility included a preference for the Ellavi UBT over the current standard (condom catheters) due to enhanced usability and time saved, the use of effective and preferred training methods delivered by local UBT champions, encouragement from facility leaders and colleagues, team management of PPH cases and strategic placement of the device and job aid posters in the wards. Relatively few barriers to use were mentioned during the study but included a lack of adjustable drip stands (>1.5 m), difficulties calculating the supply bag height according to systolic BP, challenges maintaining sterility if working alone (without a team) and the desire for further training to increase self-confidence.

To further the feasibility of the Ellavi UBT, Sinapi registered the device in both Ghana and Kenya, and contracted local distributors in both geographies. To date it has been registered in 17 countries, including 7 in sub-Saharan Africa. To ensure sustainability, it is critical that the Ellavi UBT be included in procurement and distribution channels and in national financing schemes to remove access barriers. Sinapi developed a comprehensive training package that includes a lecture, videos and job aid posters. These user-friendly tools are available free of charge and accessible online to support local capacity-building programmes (ellavi.com).

For this study, we were limited in the number of trainings we could offer, and patient care took precedence within obstetric staff’s schedules; thus, adoption could have been enhanced. Modifications to the training instructions were also improvised (bag height adjustment and frequency, removal before 6–8 hours) in both settings but further implementation research may be needed for optimisation. Although we evaluated sustainability of the Ellavi in the targeted hospitals, PPH is a rare event and our study duration was <10 months; longer durations may be more appropriate to evaluate this outcome. Providers had limited time to complete our study surveys and requested they be shortened; this may have reduced the number of post-use accounts recorded. Further, social desirability may have played a role in providers’ survey responses, and feasibility was assessed only by providers who used the Ellavi UBT. It is important to note that while the Ellavi may have been preferred by our study participants, this implementation study focused on system integration and did not address clinical efficacy outcomes, thus the non-inferiority of the Ellavi UBT to condom catheters was not demonstrated. The WHO is currently conducting a PPH management study in Vietnam to compare the clinical efficacy outcomes of five uterine devices, the Ellavi UBT was included.

Conclusion

Overall, all cadres of obstetric staff were satisfied with the Ellavi UBT as a refractory PPH intervention. This study was one of the first large-scale implementation research trials to examine the Ellavi UBT as a novel, free-flow, preassembled system for refractory PPH care. We found the device was appropriate, acceptable and feasible within maternal healthcare packages at all facility levels tested.

Data availability statement

Data are available in a public, open access repository. The data generated by our team of coauthors from the six study facilities are publicly available on Figshare and were used in the writing of this article.34

Ethics statementsPatient consent for publication

Not applicable.

Ethics approval

This study involves human participants and was approved by PATH Research Ethics Committee #1514537; PATH Research Ethics Committee #1512602; Kenyatta National Hospital Ethics Review Committee (none); Ghana Health Service Ethics Review Committee (GHS-ERC014-01-20). Participants gave informed consent to participate in the study before taking part.

Acknowledgments

We greatly appreciate the contributions of Dr James Gitonga, Deputy Director of Medical Services within Kenya’s Ministry of Health, who passed away in February 2022 at the end of the study, prior to publication. The team would also like to thank Dr Kofi Issa, the Director of Family Health Division of the Ghana Health Service. We appreciate the greater Devices, Diagnostics and Drugs to Address Women’s Needs (D3AWN) team at PATH, led by Patricia Coffey, and the administrative staff on this project: Peggy King, Jessica Bolich, and Robbie Adams.