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Objectives Use of intrauterine balloon tamponades for refractory postpartum haemorrhage (PPH) management has triggered recent debate since effectiveness studies have yielded conflicting results. Implementation research is needed to identify factors influencing successful integration into maternal healthcare packages. The Ellavi uterine balloon tamponade (UBT) (Ellavi) is a new low-cost, preassembled device for treating refractory PPH. Design A mixed-methods, prospective, implementation research study examining the adoption, sustainability, fidelity, acceptability and feasibility of introducing a newly registered UBT. Cross-sectional surveys were administered post-training and post-use over 10 months. Setting Three Ghanaian (district, regional) and three Kenyan (levels 4-6) healthcare facilities. Participants Obstetric staff (n=451) working within participating facilities. Intervention PPH management training courses were conducted with obstetric staff. Primary and secondary outcome measures Facility measures of adoption, sustainability and fidelity and individual measures of acceptability and feasibility. Results All participating hospitals adopted the device during the study period and the majority (52%-62%) of the employed obstetric staff were trained on the Ellavi; sustainability and fidelity to training content were moderate. The Ellavi was suited for this context due to high delivery and PPH burden. Dynamic training curriculums led by local UBT champions and clear instructions on the packaging yielded positive attitudes and perceptions, and high user confidence, resulting in overall high acceptability. Post-training and post-use, ≥79% of the trainees reported that the Ellavi was easy to use. Potential barriers to use included the lack of adjustable drip stands and difficulties calculating bag height according to blood pressure. Overall, the Ellavi can be feasibly integrated into PPH care and was preferred over condom catheters. Conclusions The training package and time saving Ellavi design facilitated its adoption, acceptability and feasibility. The Ellavi is appropriate and feasible for use among obstetric staff and can be successfully integrated into the Kenyan and Ghanaian maternal healthcare package. Trial registration numbers NCT04502173; NCT05340777.
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. 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. bmjopen-2022-066907supp001.pdf bmjopen-2022-066907supp002.pdf bmjopen-2022-066907supp003.pdf 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. 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. The Ellavi uterine balloon tamponade device and quick setup reference instructions. 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). 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. 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. 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 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.
