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: 10570927
• 负责人: Sundeep Dronawat
• 金额: $ 62.91万
• 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 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10570927
• 关键词: 3D Print; Appointment; Biological; Caring; Clinic; Clinical; Code; Companions; Computer software; County; Coupled; Data; Data Set; Development; Device Designs; Devices; Diabetes Mellitus; Discipline of obstetrics; Electronics; Engineering; Ensure; Evaluation; Face; Fetal Heart Rate; 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; Marketing; Maternal Health Services; Measurement; Measures; Medical Device; Minority; Monitor; Morbidity - disease rate; Mothers; Outpatients; Participant; Patient Care; Patients; Performance; Personal Satisfaction; Phase; Pregnancy; Pregnant Women; Prenatal care; Procedures; Resource-limited setting; Resources; Risk; Risk Factors; Rural; Rural Community; Safety; 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; biomaterial compatibility; clinical decision-making; clinical practice; cohort; commercialization; cost; cytotoxicity; data exchange; data sharing; engineering design; fetal; health care availability; health care quality; heart rate monitor; human subject; improved; improved outcome; in vitro testing; infant outcome; innovation; manufacture; maternal outcome; minority communities; mobile application; monitoring device; mortality; novel; obstetric care; obstetric services; 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 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，以 每两周一次，直到怀孕结束和分娩期间。这种监测是通过电子设备执行的 胎儿监护仪(EFM)可减少并发症的发生，同时最大限度地减少不必要的需求 产科干预。这对高危怀孕的妇女来说尤其重要。监督不力 增加发病率、死亡率和不良婴儿结局的风险。不幸的是，许多女性，特别是在 农村和少数民族社区面临着许多障碍，如足够的时间和资源来进行适当的产前护理 就像EFM。此外，医院使用的EFMS不是便携式的，对于中年到年龄段的人来说可能昂贵得令人望而却步 资源匮乏的社区。另一方面，家用监视器只测量一个参数，因此 未被批准用于临床决策。Fresh Life‘s Solution是一种基于正在申请专利的新型EFM系统 工程设计。我们的创新使我们能够制造出像医院EFM一样精确的EFM系统， 但成本只有它的一小部分，同时保持了具有远程监控功能的便携大小。商业化 这一系统将通过减少产前所需的费用和时间来增加获得必要医疗保健的机会 照顾病人和医疗保健提供者。 在一个成功的第一阶段计划中，Ftal Life达到了第一阶段的所有里程碑，结果是：1)开发了一个原型 系统(设备和面向患者的移动应用程序)和2)确认该系统可供孕妇使用 并且可以检测到宫缩和胎心率信号。第一阶段计划的完成对 支持拟议的第二阶段方案，该方案将侧重于完成和验证EFM系统 510(K)许可的远程监测能力。第二阶段的工作将包括完成系统与 添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 在对怀孕受试者进行的统计动力研究中的系统(目标3)。第二期工程圆满完成 计划将提供510(K)申请所需的关键性能和安全数据，以及支持 它用于远程医疗，这两者都是成功的市场部署所必需的。