Portable Affordable Innovative and Smart Device-Coupled Electronic Fetal Monitoring System to Improve Rural Access to Obstetrics Services and Improve Outcomes in Rural Communities

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PROJECT SUMMARY To ensure fetal well-being, obstetricians monitor fetal heartrate (FHR) and uterine contractions on a weekly to bi-weekly basis towards the end of pregnancy and during labor. Such monitoring is performed with an electronic fetal monitor (EFM) to decrease the development of complications while minimizing the need for unnecessary obstetric interventions. This is especially important for women with high-risk pregnancies. Inadequate monitoring increases the risk of morbidity, mortality, and poor infant outcomes. Unfortunately, many women, especially in rural and minority communities, face many barriers like sufficient time and resources to adequate prenatal care like EFM. Furthermore, EFMs used in hospitals are not portable and can be prohibitively expensive for mid- to low-resource communities. On the other hand, monitors for home use measure only 1 parameter and therefore not approved for clinical decision making. Fetal Life’s solution is a novel EFM system based on a patent-pending engineering design. Our innovation enables us to manufacture an EFM system as accurate as a hospital EFM, but at a fraction of the cost, while maintaining a portable size with telemonitoring capabilities. Commercializing this system will increase accessibility to necessary healthcare by reducing the cost and time required for prenatal care for patients and healthcare providers. In a successful Phase I program, Fetal Life met all Phase I milestones resulting in: 1) development of a prototype of the system (devices plus patient-facing mobile app) and 2) confirmation that the system is usable by pregnant patients and can detect contraction and FHR signals. Completion of the Phase I program was critical to supporting the proposed Phase II program that will focus on completing and validating the EFM system with telemonitoring capabilities for 510(k) clearance. Phase II efforts will include completing the system with the addition of the healthcare provider-facing app and validating its accuracy with in vitro testing (Aim 1), manufacturing and completing standard safety testing (Aim 2), and validating accuracy and usability of the system in a statistically powered study with pregnant subjects (Aim 3). Successful completion of the Phase II program will provide critical performance and safety data necessary for a 510(k) filing, and key data supporting its use for telehealth, both of which are required for successful market deployment.