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.

项目摘要 为了确保胎儿健康，产科医生每周监测胎儿心率（FHR）和子宫收缩， 妊娠末期和分娩期间每两周一次。这种监测是用电子仪器进行的。 胎儿监护仪（EFM），以减少并发症的发展，同时尽量减少不必要的 产科干预。这对高危妊娠的妇女尤其重要。监测不足 增加发病率、死亡率和婴儿不良结局的风险。不幸的是，许多妇女，特别是在 农村和少数民族社区面临许多障碍，如足够的时间和资源，以充分的产前护理， 比如EFM此外，在医院中使用的EFM不是便携式的，并且对于中到老年人来说可能过于昂贵。 低资源社区。另一方面，家用监护仪仅测量1个参数，因此 未被批准用于临床决策。胎儿生命的解决方案是一种新颖的EFM系统的基础上， 工程设计我们的创新使我们能够制造出与医院EFM一样精确的EFM系统， 但成本只有一小部分，同时保持了具有远程监护能力的便携式尺寸。商业化 该系统将通过减少产前检查所需的费用和时间， 为患者和医疗保健提供者提供护理。 在一个成功的第一阶段计划，胎儿生活满足所有第一阶段的里程碑，导致：1）原型的发展 系统（设备加上面向患者的移动的应用程序）和2）确认系统可由孕妇使用 患者，并可以检测收缩和胎心率信号。第一阶段计划的完成对于 支持拟议的第二阶段计划，重点是完成和验证EFM系统， 510（k）许可的远程监控能力。第二阶段的工作将包括完成该系统， 增加面向医疗保健提供者的应用程序，并通过体外测试验证其准确性（目标1）， 制造和完成标准安全测试（目标2），并验证 在妊娠受试者的统计学把握度研究中使用该系统（目标3）。成功完成第二阶段 该计划将提供510（k）申报所需的关键性能和安全性数据，以及支持 将其用于远程保健，这两者都是成功的市场部署所必需的。