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

便携式经济实惠的创新智能设备耦合电子胎儿监护系统可改善农村地区获得产科服务的机会并改善农村社区的成果

• 批准号: 10382687
• 负责人: Swati Shah
• 金额: $ 102.2万
• 依托单位: FETAL LIFE, LLC
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-23 至 2023-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10382687
• 关键词: 3D Print; Address; Appointment; Biological; Caring; Charge; Clinic; Clinical; Code; Companions; Computer software; County; Coupled; Data; Data Set; Development; Device Designs; Devices; Diabetes Mellitus; Discipline of obstetrics; Engineering; Ensure; Evaluation; Face; Fetal Monitoring; Fetal health; Frequencies; Funding; Gel; Gynecology; Health Personnel; Healthcare; High-Risk Pregnancy; Home; Hospitals; Improve Access; In Vitro; Intervention; Legal patent; Life; Low income; Manikins; Maternal Health Services; Measurement; Measures; Medical Device; Minority; Monitor; Morbidity - disease rate; Mothers; Outpatients; Participant; Patient Care; Patients; Performance; Personal Satisfaction; Phase; Pregnancy; Pregnancy Complications; Pregnant Women; Prenatal care; Procedures; Resource-limited setting; Resources; Risk; Risk Factors; Rural; Rural Community; Rural Minority; Safety; Services; Signal Transduction; Small Business Technology Transfer Research; Study Subject; Surveys; System; Technology; Testing; Time; United States National Institutes of Health; Universities; Uterine Contraction; Woman; barrier to care; base; biomaterial compatibility; clinical decision-making; clinical practice; cohort; commercialization; cost; cytotoxicity; data exchange; data sharing; engineering design; fetal; health care availability; health care quality; human subject; improved; improved outcome; in vitro testing; infant outcome; innovation; minority communities; mobile application; monitoring device; mortality; novel; obstetric care; portability; pregnant; programs; prototype; remote health care; remote monitoring; rural underserved; safety testing; skin irritation; telehealth; telemonitoring; underserved community; usability; vibration

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.

项目总结