Post-partum hemorrhage (PPH) is one of the leading causes of maternal mortality in Kenya and contributes to approximately one-third of all maternal deaths [1, 2]. Considerable effort and more catalytic investments are required for Kenya to achieve the SDG goal of only 70 deaths per 100,000 live births by 2030 [3].  

In 2012, the WHO began recommending the uterine balloon tamponade (UBT) for PPH management when uterotonic drugs failed or were not available [4]. The UBT is a non-surgical approach to treating PPH. Commercially available, quality-assured UBTs that have received regulatory approval, are prohibitively expensive for low- and middle-income countries (LMICs). To fill this gap, some health care workers in LMICs improvise condom catheters at the point of care by gathering and assembling the essential materials at the time a woman is experiencing uncontrolled PPH. This scenario is not optimal as it adds time and pressure on the provider. Additionally, condom catheters are not regulatory-approved medical devices, thus quality control and integration into supply chains is problematic. In response to this gap, PATH (Seattle, USA) in collaboration with Sinapi Biomedical (Stellenbosch, South Africa) designed the Ellavi UBT, a preassembled, effective, and low-cost device. The Ellavi UBT fills the gap between the expensive devices and the condom catheter balloon kits as it is an inexpensive (<$15), free-flow, pressure-controlled system that allows the uterus to contract. The Ellavi UBT received regulatory approval from the Kenyan Pharmaceutical and Poison Board in October 2019. 

This implementation research study will generate evidence to inform the successful uptake and adoption of the Ellavi UBT within Kenyan PPH management programs. We aim to improve the likelihood that the Ellavi UBT will be integrated into the Kenyan health care system by obtaining critical feedback from stakeholders and health care providers on the barriers and facilitators towards its successful adoption and roll out. Our purpose is to generate evidence for Kenyan stakeholders to use in their decision-making around the use of Ellavi UBT in Kenyan PPH management programs.

Introduction: Post-partum hemorrhage (PPH) is one of the leading causes of maternal mortality in Kenya and contributes to approximately one-third of all maternal deaths [1, 2]. Considerable effort and more catalytic investments are required for Kenya to achieve the SDG goal of only 70 deaths per 100,000 live births by 2030 [3].  In 2012, the WHO began recommending the uterine balloon tamponade (UBT) for PPH management when uterotonic drugs failed or were not available [4]. The UBT is a non-surgical approach to treating PPH. Commercially available, quality-assured UBTs that have received regulatory approval, are prohibitively expensive for low- and middle-income countries (LMICs). To fill this gap, PATH (Seattle, USA) in collaboration with Sinapi Biomedical (Stellenbosch, South Africa) designed the Ellavi UBT, a preassembled, low-cost, effective, free-flow, pressure-controlled system that allows the uterus to contract. The Ellavi UBT received regulatory approval from the Kenyan Pharmaceutical and Poison Board in October 2019. 

Objectives: We aim to generate evidence that informs the successful uptake and adoption of the Ellavi UBT within Kenyan PPH management programs for both public and private sector programs. Specifically, we will: 1) determine the adoption, penetration, sustainability and fidelity of integrating the Ellavi UBT device into PPH programs; 2) determine the appropriateness, acceptability and feasibility of using the Ellavi UBT by exploring user comprehension, accuracy of use, perceptions of the device, attitudes towards the device, user confidence, usability, facilitators of use, barriers to use, use-patterns, and insights into training effectiveness; 3) determine the cost of introducing the Ellavi UBT into the PPH management protocols; and 4) disseminate the findings nationally and internationally to support information sharing, increased awareness of the role of the UBT for refractory PPH, and adoption of its use.

Methods: We will collect data at three health facilities (Kenyatta National Hospital, Mbagathi Hospital, St. Mary’s Medical Mission) over a period of six months starting in September 2020. To determine adoption, penetration, sustainability, and fidelity we will collect hospital level data on training rates, facility adoption of Ellavi UBT, provider usage, fidelity to training, and sustained correct usage.  To determine appropriateness, acceptability and feasibility we will: 1) survey all obstetrical care workers (up to 200) following a training course on PPH and Ellavi UBT use to solicit feedback for improvement on course components (lecture, virtual webinar, and simulation modeling); 2) obtain feedback on the Ellavi UBT device by surveying up to 100 health care providers post-usage; 3) obtain secondary data from hospital registries on the number of births, PPH events, refractory PPH cases, uses of condom catheters, and uses of Ellavi UBT devices.  To estimate costs we will identify: 1) the costs of training, 2) the costs of country level activities associated with integration of the Ellavi UBT into the PPH management protocols (i.e. meetings, advocacy, communication materials), and 3) the cost of procuring the Ellavi UBT in comparison to the cost of condom catheters (direct costs, stock-out issues, time spent towards assembly). To disseminate our study findings, PATH and UofN will organize a regional meeting with key stakeholders and present at international conferences.

Utility: We aim to improve the likelihood that the Ellavi UBT will be integrated into the Kenyan health care system by obtaining critical feedback from stakeholders and health care providers on the barriers and facilitators towards its successful adoption and roll out. Our purpose is to generate evidence for Kenyan stakeholders to use in their decision-making around the use of Ellavi UBT in Kenyan PPH management programs.