Portable Affordable Innovative and Smart Device-Coupled Electronic Fetal Monitoring System to Improve Rural Access to Obstetrics Services and Improve Outcomes in Rural Communities

Obstetricians measure fetal heartrate (FHR) and uterine contractions to evaluate fetal health during pregnancy and labor. This monitoring is performed to decrease the development of complications while minimizing the need for unnecessary obstetric interventions and is especially important for women with high-risk pregnancies. However, many women, especially in rural areas, do not have the time or resources to reach an obstetrician and the lack of monitoring increases the risk of morbidity, mortality, and poor infant outcomes. Thus, there is a significant need for improved access to specialized healthcare providers like obstetricians. Because FHR and contractions are detected in separate locations of the mother’s abdomen, two separate devices are required- a tocometer to measure contractions and an FHR monitor. In the hospital, both are used to simultaneously measure contractions and FHR and the data is fed to and displayed on a large and separate machine called the cardiotocograph (CTG). Meanwhile, current monitors for home use can measure only 1 parameter because there is no method to simultaneously read data from 2 separate devices on an app. Additionally, these home devices are not approved for clinical decision-making. Fetal Life developed a patent- pending engineering design for a tocometer that is significantly smaller and more affordable than those in clinical use. To build upon this, Fetal Life will develop a portable and affordable system with its existing tocometer and an FHR monitor for at-home use that can send both sets of data to a hub that will be able to simultaneously send the data to an app on a commercial tablet to a remote obstetrician for real time monitoring. The development of the novel tocometer and the use of a tablet eliminates the need for a separate CTG, which will reduce overall cost and size. In addition to increasing access to necessary healthcare, this product will reduce cost and time required for healthy mothers and redirect resources to mothers with high-risk pregnancies. The goal of this Phase I STTR proposal is to develop the system of products and evaluate its usability for at- home use. This will be accomplished through the execution of 3 aims. In Aim 1, Fetal Life will repackage a consumer FHR monitor to be of similar size to the tocometer and incorporate a serial port onto each device that will send continuous data to a hub device through a cable and redesign the cases to be appropriate for use with a belt. In Aim 2, we will build a hub with two serial inputs to receive FHR and contraction data and develop its software to integrate the data and display it on a single app (iOS and Android) on commercial tablets. In Aim 3, we will perform a small proof-of-concept human subject to demonstrate feasibility with 5 pregnant women and evaluate its usability in an at-home context through surveys. This Phase I program will develop the prototype and provide necessary proof-of-concept data to support further development and a larger Phase II clinical trial that will center on its accuracy and efficacy.PROJECT NARRATIVE Measuring fetal heartrate and uterine contractions is a common procedure performed by obstetricians to ensure mother and fetal health during pregnancy and labor. However, many pregnant mothers, especially in rural areas, do not have the resources or time to reach an obstetrician and currently available at-home products are not used to make clinical decisions. Fetal Health will lower the barriers to healthcare access for rural mothers by developing a portable and affordable telemonitoring product that can measure fetal heartrate and uterine contractions and simultaneously send both sets of data to a remote doctor to make critical decisions in real time that will ultimately improve mother and fetal health.