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
基本信息
- 批准号:10382687
- 负责人:
- 金额:$ 102.2万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 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:
- 关键词:3D PrintAddressAppointmentBiologicalCaringChargeClinicClinicalCodeCompanionsComputer softwareCountyCoupledDataData SetDevelopmentDevice DesignsDevicesDiabetes MellitusDiscipline of obstetricsEngineeringEnsureEvaluationFaceFetal MonitoringFetal healthFrequenciesFundingGelGynecologyHealth PersonnelHealthcareHigh-Risk PregnancyHomeHospitalsImprove AccessIn VitroInterventionLegal patentLifeLow incomeManikinsMaternal Health ServicesMeasurementMeasuresMedical DeviceMinorityMonitorMorbidity - disease rateMothersOutpatientsParticipantPatient CarePatientsPerformancePersonal SatisfactionPhasePregnancyPregnancy ComplicationsPregnant WomenPrenatal careProceduresResource-limited settingResourcesRiskRisk FactorsRuralRural CommunityRural MinoritySafetyServicesSignal TransductionSmall Business Technology Transfer ResearchStudy SubjectSurveysSystemTechnologyTestingTimeUnited States National Institutes of HealthUniversitiesUterine ContractionWomanbarrier to carebasebiomaterial compatibilityclinical decision-makingclinical practicecohortcommercializationcostcytotoxicitydata exchangedata sharingengineering designfetalhealth care availabilityhealth care qualityhuman subjectimprovedimproved outcomein vitro testinginfant outcomeinnovationminority communitiesmobile applicationmonitoring devicemortalitynovelobstetric careportabilitypregnantprogramsprototyperemote health careremote monitoringrural underservedsafety testingskin irritationtelehealthtelemonitoringunderserved communityusabilityvibration
项目摘要
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
项目成果
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