Preventing Prematurity by Predicting Preeclampsia

Preeclampsia is a prenatal condition in which high blood pressure commonly leads to early delivery. It accounts for 20% of children born preterm and puts infants at increased risk for developmental disorders, functional disabilities, and more, highlighting the need to prevent prematurity so children will experience optimal development. Pregnant women in developing countries see greater risk for preeclampsia and face health care barriers including lack of transportation and prenatal education. Our solution, Preventing Prematurity by Predicting Preeclampsia, detects the risk preeclampsia by measuring a mother’s blood pressure on her side and back. The device prevents preeclampsia by optimizing kidney blood flow through monitoring of a therapeutic resting position (e.g. sleeping sideways). Expectant mothers can longitudinally and autonomously manage their risk from home, with results recorded and distributed to their clinician. This tool has the potential to improve pregnancy outcomes by empowering mothers to manage and prevent hypertension.

Preeclampsia is a pregnancy-specific disorder that affects 2-8% of all pregnancies. This condition presents with hypertension and is associated with high risk of morbidity and mortality for both mother and child due to the growing uterus adversely affecting blood flow to the kidneys. This results in many clinical issues, but specifically, premature birth. In developing countries, preeclampsia accounts for one-quarter of all neonatal deaths, and infant mortality rates are three times higher than in high-income countries. Of the 30 million children born in these poor conditions annually, those that do survive face the consequences of preterm delivery and start life at a severe disadvantage. Compared with children born at term, they are more likely to develop cognitive abnormalities, motor deficits, cerebral palsy, heart disease, diabetes, vision/hearing loss, anxiety and depression, and problems that negatively impact managing daily activities. By catching and treating preeclampsia early, we aim to improve the health of mothers and give children a better start to life. A simple, inexpensive, and effective at-home device is needed to identify women at risk for developing preeclampsia. This will allow physicians to prioritize prenatal care for those who need it most and provide proper treatment to manage this condition.

Our goal is to serve all pregnant women, and children who are at risk for complications due to preeclampsia. In particular, women who have little access to prenatal care often need to travel long distances to get to medical appointments, if even available. Remotely identifying patients who need extra care can save time and improve outcomes. Preventing Prematurity by Predicting Preeclampsia will allow women in remote areas to track blood pressure and conduct an automated test throughout their pregnancies in their own homes without frequent visits to a clinic. This will empower them to manage their own risk using the device and a therapeutic resting position, improving maternal health and decreasing preterm births. The device will continually be improved through feedback from these women. Understanding what they need from the device will allow us to further enable women to take charge of their own and their child’s health. As fewer pregnancies are delivered preterm, fewer babies will develop complications induced by prematurity. 

Preventing Prematurity by Predicting Preeclampsia is more than just a diagnostic tool- it is a management device that can help ensure that an at-risk woman sleeps in a therapeutic position at night (e.g. sideways), and is designed to communicate with her if she inadvertently rolls on her side. It measures the patient’s blood pressure (BP) and monitors body position using a sensor. Direct feedback from the body position sensor to a phone application allows the user to adjust positioning to overcome problems with the existing versions of this test (the supine pressor test, or SPT) that require trained medical personnel. We ultimately want to give pregnant women the ability to autonomously monitor their BPs in the latter half of their pregnancy without the need for frequent visits to a clinic. This tool will be especially useful for women who have limited mobility and access to reliable clinical care, a situation many patients in low and middle income countries experience. Ultimately, we aim to increase the sensitivity of the SPT by giving expecting mothers the ability to monitor their health longitudinally during pregnancy without the need to travel to a clinic. 

Preventing Prematurity by Predicting Preeclampsia uses a noninvasive BP cuff and an inertial measurement unit sensor (or IMU) that tells the device how the patient is positioned. Paired with a smartphone, the device will be able to guide users through the steps of the test, direct patients to change positioning if necessary, display blood pressure immediately and longitudinally, and send these results to the patient’s designated physician.

Currently we are refining the device in high resource centers such as Purdue University and Indiana University Health to hone its functionality. Results from preliminary studies on the effects of light exercise and a baseline change in blood pressure will be incorporated into the algorithm used for the device to ensure stable blood pressure before each use. Once the device is better optimized locally, we can utilize our relationship with Kenyan colleagues for further evaluation. In the near-term, our global advocacy is limited to a communication campaign: “Sleep Sideways.” 

Preventing Prematurity by Predicting Preeclampsia makes use of newer technology to overcome the limitations of an older, but correct test (the supine pressor test, SPT) that came to disuse as a result of decreased specificity from a lack of standardization. When the SPT was first established, the clinical community did not understand the mechanism of why it worked. As a result implementation, sensitivity, and efficiency were poor. Our approach to solve this prominent issue stems from the insight that mechanical obstruction of renal venous flow compromises kidney perfusion and causes hypertension. Furthermore, in the 1950s, resting on one’s back was shown to increase intrarenal pressure causing outflow obstruction, proving that sleeping sideways may prevent preeclampsia. These physiologic insights shine a new light on the concept of the SPT, and they also help us understand how to better implement this test for clinical benefit. Our solution integrates an automatic blood pressure cuff and bluetooth IMU position sensor through an application to guide the patient through the test. By automating the process, we are implementing a standard procedure, resulting in the improved prediction of who is at increased risk for developing preeclampsia during their pregnancy. We also make use of wireless technology to enable patients to use telemedicine to communicate with their physicians about their results. Our uniquely discovered insights drove us in the direction to re-invent the SPT and make it more useful, changing the lives of mothers and children.

Our solution integrates an automated BP cuff, an inertial measurement unit, and a smartphone application. These components work together to standardize the supine pressor test (SPT). The BP cuff is not new technology, but we incorporate it with an IMU which communicates to the patient through the app if she is in the correct orientation. If she is not, the app guides her so that she can orient herself correctly for the supine pressor test to proceed. 

Thus, the algorithms used in the smartphone application in tandem with the Bluetooth IMU sensor are what standardize the test. By incorporating the app with the BP cuff, women can guide themselves through the steps of the supine pressor test without having a physician present. Once the patient has completed a round of the supine pressor test, the app stores the data in her personal account. The patient can then choose to share this data with her physician electronically. However, if a supine pressor test result shows that the patient is at high risk of developing preeclampsia, the data will automatically be sent to the patient’s clinic/physician.

On a day-to-day basis, our solution will be used to track and predict the patient’s risk for preeclampsia. In using the device, patients will become more educated about the condition and what to look for throughout their pregnancy. Daily autonomous monitoring of the patient will permit fewer visits to the clinic, saving time and money for both the patient and the healthcare provider. Combining knowledge about the condition and longitudinal results will result in improved pregnancy outcomes for the mother and child. The child can start a life with better opportunities to develop physically, cognitively, and emotionally by enduring fewer pregnancy complications. Scaled up, this solution has the potential to decrease maternal and infant mortality rates in not only Eldoret, Kenya where we plan to test the device, but also worldwide.

The World Health Organization hopes to tackle low birth weight by 2025 by reducing the number of children born underweight by 30%. When the mothers are better educated about this condition, they can utilize our solution and take the proper actions to carry their children to full-term. Instead of countless pre-term babies with low birth weight being prominent in rural areas, with our device, they will be born at term with higher birth weights. They will be able to grow and reach their potential.

Patients and physicians will also have the ability to provide feedback on the comfort and usability of the device, allowing us to continually improve our solution.

With our device still in development, we are not currently serving anyone. Through the pilot study and usability study we aim to complete in Indiana and Eldoret, Kenya respectively, in the next year we aim to work with approximately 200 people. Beyond the next year, our goal is to perform a clinical trial that will reach approximately 500 expectant mothers and infants. We estimate we will assist 20 community health workers and physicians in Eldoret in the next 5 years to identify these women who are at risk. Scaling the device and targeting developing regions, we estimate our solution has the potential to serve 144 million mothers and infants in developing regions alone.

Our goal within the next year is to finish our Preventing Prematurity by Predicting Preeclampsia prototype, complete a longitudinal human study showing the efficacy of this device, and continue working  with our Kenyan colleagues to begin showing the benefits of this approach in low-resource settings. Completing a pilot study before traveling to Kenya will allow us to obtain usability data on the full prototype  and to confirm the effectiveness of the device in predicting preeclampsia before we travel to Kenya to obtain usability data on our target population.

Within the next 5 years and beyond, after our usability study in Kenya we hope to begin a clinical trial there in collaboration with Moi Hospital and Huruma sub-county Hospital. Following this we will pursue implementing our solution into the prenatal care plan in these hospitals and in other low resource settings. As we scale this device, we will use big data strategies to improve risk assessment.

Over the next year our primary barriers are financial and technical. As we finish the prototype we will need to consider how to best optimize our data acquisition, storage, and transmission all while maintaining a user-friendly smartphone app. Obtaining funding is the first step towards finishing the prototype and a pilot longitudinal human study. While we will also need funding beyond the next year, our barriers following prototype completion will primarily be cultural and legal. Moving towards implementation in Kenya, we are unsure how the environmental, cultural, and societal barriers might affect adoption of our device. Approval from the FDA and other international regulatory agencies will also be important to eventual implementation in prenatal care plans in developing countries.

Securing funding will help us see this project through development and into implementation. We are actively applying for and searching out a variety of funding sources. Beyond this, we will be working with physicians and patients in Kenya to understand what cultural barriers we may face as this device becomes ready for use in Eldoret, Kenya. We are also working with the Office of Technology Commercialization at Purdue and hope to establish collaborations from the MIT Solve competition to pursue FDA clearance.

We currently have nine people working on our team. Dr. Craig Goergen and Dr. George Wodicka of Purdue University provide guidance as biomedical engineers. Dr. David Reuter is a pediatrician at Seattle Children’s Hospital who provides guidance on the mechanism behind preeclampsia. Dr. David Haas, of Indiana University School of Medicine, and Dr. Edwin Were and Mr. Benson Milimo of Moi Hospital in Kenya, will assist with the development and feedback of the device as we begin clinical trials. Jessica Ma, Aditi Acharya,and Jennifer Anderson are the students who perform the day-to-day work of our team.

Connections we have already developed with physicians and others make us well placed to develop this solution. Our established relationships with  Dr. David Reuter, a pediatrician at Seattle Children’s Hospital, and other physicians at Indiana University School of Medicine and in Kenya mean we already have some of the connections needed to move this solution forward. Additionally, resources at Purdue University, including the Office of Technology Commercialization and the Burton D. Morgan Center for Entrepreneurship, will allow us to easily seek commercialization help as needed.

We are currently partnering with the Indiana University School of Medicine to obtain pilot usability and feasibility data. It is important that the device is comfortable and easy to use, and effective at tracking the patient’s risk for preeclampsia over multiple uses.

We also have a relationship with Moi Teaching Hospital and Huruma Sub-County Hospital in Kenya. Once our usability and feasibility testing is complete, we will partner with them to start human studies utilizing our device there.

Lastly, we have a research agreement with Spacelabs Healthcare. They have provided us with a blood pressure cuff to create our prototype.

We will help pregnant women, their infants, and physicians through the implementation of our device. By using Preventing Prematurity by Predicting Preeclampsia, the non-preeclamptic patient will save time and money by visiting the clinic only when necessary. The preeclamptic patient who uses the device will be able to return home sooner following delivery, will see lower maternal and infant mortality rates, and improved developmental conditions for their child all as a result of detecting (and thus being able to treat) the condition earlier.

Infants who are premature and smaller than average are at higher risk for various issues throughout their life. By identifying and treating preeclampsia earlier, infants will be able to stay and mature in the womb longer, leading to a reduction in low birthweight and prematurity. With more time to be nurtured and developed, they will be able to experience prosperous futures. 

This device will allow physicians to be more efficient with their time. When patients monitor their BP daily and do not see any significant changes over time, they may not need to be seen as often in the clinic. This reduction in the number of patients seen will allow physicians to spend more time with the women who need it, improving the quality of physician-patient interaction. Additionally, physicians and mothers will have greater peace of mind. Catching preeclampsia earlier will allow physicians to treat it earlier, resulting in fewer patient deaths and complications, and mothers and infants can be guaranteed better care.

To complete the prototype and clinical trials for this solution, we are actively seeking funding through grants. Moving beyond a pilot study, we will be seeking to work directly with a company to distribute the product through networks they have already established.

Funding and connections acquired as a result of the Solve Competition will allow us to accelerate this project from prototype to full device and help us begin making a positive impact. 

We are most interested in partnering with non-profit organizations that focus on global health such as the WHO or UNICEF.

If selected for the Innovation for Women Prize, our team would use the prize to fund development and improvement of the device. This would be in the form of supplies, travel to and from Kenya and potentially other parts of the world to obtain feedback from our target population, management of data, and more. This award and the connections that would result from it would jump start our solution and allow us to have an immediate and long-term positive impact.