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 为了确保胎儿福祉，产科医生每周监视胎儿赫特拉特（FHR）和子宫收缩 每两周在怀孕结束和分娩期间。通过电子进行此类监控 胎儿监测器（EFM）减少并发症的发展，同时最大程度地减少不必要的需求 产科干预措施。这对于患有高危妊娠的女性尤其重要。监视不足 增加发病率，死亡率和婴儿预后不良的风险。不幸的是，许多妇女，尤其是 粗糙和少数民族社区，面临许多障碍，例如足够的时间和资源来充足产前护理 像EFM。此外，医院中使用的EFM不可移植，可以禁止中高级 低资源社区。另一方面，监视家庭使用度量仅1个参数，因此 未批准临床决策。胎儿生活解决方案是一种基于专利的新型EFM系统 工程设计。我们的创新使我们能够制造像医院EFM一样准确的EFM系统， 但是，以一小部分成本，同时保持具有远程监控功能的便携式尺寸。商业化 该系统将通过减少产前所需的成本和时间来增加必要的医疗保健的可访问性 照顾患者和医疗保健提供者。 在成功的I阶段计划中，胎儿生活达到了所有I期里程碑，导致：1）开发原型 系统（设备加患者的移动应用程序）和2）确认该系统可通过怀孕使用 患者可以检测收缩和FHR信号。 I阶段计划的完成至关重要 支持拟议的II期计划，该计划将专注于完成和验证EFM系统 510（k）间隙的远程监控功能。第二阶段的工作将包括与 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（AIM 1）， 制造和完成标准安全测试（AIM 2），并验证准确性和可用性 与怀孕受试者进行统计动力研究的系统（AIM 3）。成功完成II期 计划将提供510（k）备案所需的关键绩效和安全数据，并提供支持的关键数据 它用于远程医疗，这两者都是成功的市场部署所必需的。