Smart Postpartum Haemorrhage Volumetric Drape (SMART-PVD)

Uganda’s maternal mortality ratio as of 2016 was reported at 336 deaths per 100,000 live births translating to approximately 15 women dying everyday due to preventable conditions like haemorrhaging, hypertension among others. Postpartum haemorrhage is one of the major causes of maternal mortality in developing countries like Uganda contributing 25% to maternal deaths. It is commonly attributed to uterine atony that occurs within the first hour of delivery leading to severe bleeding. Therefore, delay in recognition of postpartum haemorrhage exposes women to the risks of blood transfusion, anaemia, and ultimately death that could have been prevented by on time and accurate estimation of blood loss. Unfortunately, it has been reported that health workers have significant difficulty in estimating blood loss. Furthermore, the existing blood estimations techniques such as visual estimation has been considered inaccurate by several studies whereas weighing of soaked cotton and blood collected in bags, kidney dishes are deemed time consuming for busy settings with cost implications related to its implementation. Despite the ineffectiveness of these techniques, they are still the standard of diagnosis of postpartum haemorrhage in most developing countries leading to delay of initiation of treatment resulting into maternal morbidity and mortality

The Smart Postpartum Haemorrhage Volumetric Drape (SMART-PVD) is a device designed for the purpose of uniform collection and accurate measurement of blood lost during and after childbirth. This device will ensure that birth attendants detect the onset of postpartum haemorrhage (PPH) so that initiation of treatment is timely to prevent adverse conditions related to haemorrhaging. The device is made up of a reusable blood level sensor to detect the amount of blood collected in the disposable blood collection system during delivery after which it alerts the birth attendant of an intending PPH case basing on threshold values used to define postpartum haemorrhage in a clinical setting. The SMART-PVD is comprised of features built from locally sourced materials that provide efficient estimation of blood loss. These features include; Two pairs of elastic belts used to secure both the drape and mother in position to allow for uniform collection of blood; a low-density polyethylene pouch that is standardized to collect not more than 1000mls of blood and transparent to provide visibility to the user; blood filter that will be used to collect foreign materials that are usually mixed up with the blood during delivery.

The SMART PVD is a novel device designed specifically to help health workers detect and be proactive to mothers who are at risk of PPH. Thus, reducing the incidence of maternal morbidity and mortality due to PPH. It improves upon the existing practices in the following ways: Through Timely alerts: Current methods use visual estimation by midwives, which is limited by the physician to patient ratio of 1: 25,725 and the midwives to patient ratio is only 1: 5,000. The SMART PVD gives audible alerts of impending PPH. Accurate measurements: Current methods include weighing of soaked cotton and kidney dishes to determine blood loss. The SMART PVD includes a volumetric measurement device for accurate readings. Sophisticated but simple to use: Other relatively accurate methods of prediction require laboratory techniques that are simply not feasible at lower level settings with limited infrastructure. The SMART PVD provides efficient and timely measurement without complicated instrumentation, making it easy to instruct users in all regions of Uganda .

We are a multi-disciplinary team composed of both engineers and medical personnel able to move this innovation to the next level. The entire team has been involved with the SMART-PVD device from the prototype lab tests; with some others have participated in its inception.  The team also greatly understands the burden faced by healthcare personnel owing to the high patient to health worker ratio; more so the high mortality rate due to Post-partum haemorrhage. The team is also very passionate about this project as evidenced at the onset in the absence of funds, whereby the team managed to make progress on device development regardless. This tenacity was also witnessed during the Covid-19 pandemic that seemingly ought to have hindered project progress but didn’t. The team adapted quickly utilising online platforms for communication and interchangeably working on the prototype. We also leveraged on the power of constant communication as a team to ensure we don’t lose sight of the project and also for constant check-ins to ensure the team was in great health and in a perfect mental state.

The group has so far been successful in creating a functioning prototype, which has been tested in a lab using expired blood. 

The researchers also conducted market research with 20 midwives, who are the device's intended users and who confirmed the device's capacity to detect PPH. 

The Smart PVD device is still being worked on, and more design iterations and testing are required, particularly in the maternity ward itself through a pilot study.

This proves that it is not just a concept but a prototype.

The group has so far been successful in creating a functioning prototype, which has been tested in a lab using expired blood. The researchers also conducted market research with 20 midwives, who are the device's intended users and who confirmed the device's capacity to detect PPH. The Smart PVD device is still being worked on, and more design iterations and testing are required, particularly in the maternity ward itself

The SOLVE funding will enable us to move to our next stage of research and development by conducting a pilot/feasibility study which is a crucial aspect in technology readiness. This pilot study will be geared towards evaluating the usability and acceptability of the SMART- PVD device with the mid-wives and the mothers respectively. To conduct the pilot study, we would need Intellectual Property protection of the device, institutional approval from the Makerere University School of Medicine Research and Ethics committee and the National Council of Science and Technology. The study setting will be at the labour ward of Kawempe National Referral Hospital. The findings from this study will provide the basis for refining the overall SMART-PVD thus ensuring accuracy in blood estimation that will increase the patient satisfaction as well as staff productivity. On our pathway to implementation, this evidence of device operationality, effectiveness, and efficiency is necessary. 

Furthermore is the need to develop capabilities and skills of the team members to be able to work excellently on this project as well as at various levels of upscale even leading to commercialisation.

The SMART PVD is innovative because it provides:

1. Timely alerts: Current methods use visual estimation by midwives, which is limited by the physician to patient ratio of1: 25,725 and the midwives to patient ratio is only 1: 5,000. The SMART PVD gives audible alertsof impending PPH.

2. Accurate measurements: Current methods include weighing of soaked cotton and kidney dishes to determine blood loss. The SMART PVD includes a volumetric measurement device for accurate readings

3. Sophisticated but simple to use: Other relatively accurate methods of prediction require laboratory techniques that are simply not feasible at lower level settings with limited infrastructure.The SMART PVD provides efficient and timely measurement without complicated instrumentation, making it easy to instruct users in all regions of Uganda.

The SMART PVD is a novel device to help health workers detect and be proactive to mothers who are at risk of PPH. Thus, reducing the incidence of maternal morbidity mortality due to PPH.

This innovation mainly targets skilled health workers in all health facilities that offer obstetric services. This funding opportunity will enable us to commence with the initial plan for our technology that involves building confidence and credibility with the target users (the health workers) through actively involving them in the testing phase as well as all the feasibility study which will be conducted in one high-volume health facility to ensure an evidence-based technology and further expand our reach to 5 health facilities through a pivotal study. In the long run, this will allow for early adoption of the device once it is on the market.

The unique and novel aspect of this innovation thus necessitates acquiring Intellectual Property Rights, which stands as the first step to commercialisation. 

This funding will act as a backbone and thus enabling us to build key partnerships for example with RICE360o Institute for Global Health, the plastic manufacturing plant, the Uganda Ministry of Health and Maternal Health implementing partners across the country that will enable us to expand our reach to more health facilities, thus allowing for greater impact.

1. Pilot study conducted and device receives approval

2. Full scale clinical trial with a larger sample size

3. Intellectual Property obtained through WIPO

4. SMART PVD device obtains CE clearance

5. Established partnership with local mass manufacturing plants

6. Adaption of the device by the Government of Uganda in all public health centres.

One of the key goals under Uganda’s Millennium Development goals is goal 5that targets improving maternal health. One of the main interventions streamlined in order to achieve this goal is improving emergency obstetric care that contributes to about 80% to maternal mortality through direct causes like haemorrhaging.

The successful application of this innovation will aid in the early detection of postpartum haemorrhage, which will in turn reduce the unnecessary delays in initiating treatment and resource expenditure in the labour room preventing complications related to postpartum haemorrhage that are a major contributor to maternal deaths in Uganda. Furthermore, the innovation seeks to bridge the gap between service delivery and limited human resource in health facilities by empowering them to make timely decisions that will improve the management of postpartum haemorrhage cases.

The device consists of a graduated blood collection receptacle for directing the flow and collection of blood, a blood sensor module that comprises resistive probes, an analog to digital microcontroller, a display, and an audio signalling device.  

We employ simple and locally accessible technology of a micro-controller and probes as well as audio signal processing systems that release sounds to alert the health worker.

The team is made up of both males and females, and since the conception of the idea, there has been harmonious collaboration and cooperation. Some aspects of the project are actually headed be females so we do encourage female as well as male leadership.

This innovation mainly targets skilled health workers in all health facilities that offer obstetric services. This fund will enable us to commence with the initial plan for our technology that involves building confidence and credibility with the target users (the health workers) through actively involving them in the testing phase as well as all the feasibility study which will be conducted in one high-volume health facility to ensure an evidence-based technology and further expand our reach to 5 health facilities through a pivotal study. In the long run, this will allow for early adoption of the device once it is on the market.

The unique and novel aspect of this innovation thus necessitates acquiring Intellectual Property Rights, which stands as the first step to commercialisation. 

This funding will act as a backbone and thus enabling us to build key partnerships for example with RICE360o Institute for Global Health, the plastic manufacturing plant, the Uganda Ministry of Health and Maternal Health implementing partners across the country that will enable us to expand our reach to more health facilities, thus allowing for greater impact.

This innovation mainly targets skilled health workers in all health facilities that offer obstetric services. Previous funding opportunities including personal investments enabled us to come up with three iterative prototypes and have them tested in the lab. With this funding, we shall commence with the pilot/feasibility study to build the confidence and credibility with the target users (the health workers) through actively involving them in the labour wards. The pilot study which will be conducted in one high-volume health facility to ensure an evidence-based technology and further, expanding to 5 health facilities in a pivotal study. In the long run, this will allow for early adoption of the device once it is on the market. The unique and novel aspect of this innovation thus necessitates acquiring Intellectual Property Rights, which stands as the first step to commercialisation. This funding will act as a backbone and thus enabling us to build key partnerships for example with local plastic manufacturing plants for local production, the Uganda Ministry of Health and Maternal Health implementing partners across the country that will enable us to expand our reach to more health facilities, thus allowing for greater impact.

This project was inspired by another PPH project that some of the PUMZI team members were working on. Due to the high patient to midwife ratio, this team determined that there was a need for new methods of detecting PPH other from observation. They also determined that nurses needed assistance with their everyday tasks. Thus, this project started as a senior-year school project in 2019 and a team of two successfully created their first functional prototype that was tested on water and milk. Later, the team joined PUMZI Devices Uganda Ltd (www.pumzidevices.org ), where they were able to secure 17,000 USD from the Makerere Research and Innovation Fund (MAK RIF) in 2020.