Despite significant cost and clear evidence of health risks associated with Cesarean section surgeries, an unnecessarily large number of infants are delivered via Cesarean section (C- Section) surgeries. The high rate of C-section in the US, relative to globally accepted norms, and the associated additional cost and complications are in part, due to high false positive rate of intrapartum detection of fetal hypoxic distress using existing electronic fetal monitors. Our mission is to address this problem, and improve the state of fetal health monitoring during labor and delivery. Specifically, a team of researchers at UCDavis has developed the technology for non-invasive, transabdominal measurement of fetal arterial blood oxygen saturation (FSpO2). The technology works by shining light in the abdominal area at two specific near infrared wavelengths and subsequently, sensing the small amount of diffusely-scattered light transcutaneously. The sensed signals are processed to remove the unwanted maternal contribution to measurements, and to infer variations in sensed infrared light intensity that are strictly due to pulsation of fetal arteries. The device prototype is successfully validated in several benchtop and in-vivo tests, including in one hypoxic fetal lamb model. In this STTR Phase I project, Storx Technologies Inc., a spinoff of UCDavis founded by two researchers who invented the technology, will partner with a team of UCDavis clinical and engineering researchers to demonstrate feasibility of transabdominal FSpO2 measurement in pregnant ewe models experiencing uterine contractions. The study is organized into two complementary arms, depending on whether the fetal lamb experiences hypoxia (n=5) or not (n=5) during maternal uterine contractions. The project will provide the foundation and support for intrapartum validation of the technology in human subjects in the future. Storx has already secured the exclusive right to negotiate with UCDavis to license the underlying intellectual property, and it is expected that we will reach an exclusive IP licensing agreement with UCDavis in due course.
Public Health Relevance Statement: Project Narrative The long-term vision of this project is to significantly improve fetal health monitoring during labor and delivery, by demonstrating the feasibility of a breakthrough technology for intrapartum non-invasive, transabdominal measurement of fetal arterial blood oxygen saturation (FSpO2). Building on our preliminary work on prototyping and validation of a transcutaneous fetal pulse oximetry device, we will build an improved version of the device using which, we aim to demonstrate feasibility of transabdominal fetal pulse oximetry (TFO) under induced uterine contractions (n=5), as well as under induced uterine contractions and fetal hypoxia (n=5) in pregnant ewe models.
Project Terms: Abdomen; Address; Agreement; Animal Model; Aorta; Area; arm; Arteries; Asphyxia Neonatorum; Blood; Blood flow; Businesses; Catheters; Cesarean section; Clinical; Clinical Engineering; Conservatism; cost; Detection; Devices; Diffuse; Distress; experience; fetal; fetal blood; Fetal health; Fetal Heart Rate; Fetal Monitoring; Fetal Tissues; fetus hypoxia; Foundations; Future; Gestational Age; Goals; Gold; Health; human subject; Hypoxia; improved; in vivo; in vivo evaluation; Infant; Intellectual Property; Intervention; intrapartum; Joints; Licensing; Light; light intensity; light scattering; Measurement; Measures; Mediation; Mission; Modeling; Monitor; Motion; myometrium; Operative Surgical Procedures; Oxygen; Oxytocin; Phase; Physiologic pulse; pregnant; pressure; Process; Protocols documentation; prototype; Pulse Oximetry; Research; Research Personnel; Risk; Secure; Signal Transduction; simulation; Small Business Technology Transfer Research; soft tissue; Techniques; Technology; technology validation; Testing; Thick; Time; Tissues; Translating; Uterine Contraction; Uterus; Validation; Variant; Vision; Work
