Randomized controlled trial of a novel digital health solution to enable remote fetal monitoring in high risk pregnancies

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Project Summary Women carrying high risk pregnancies require frequent, in-person fetal monitoring appointments to reduce their risk of stillbirth. However, public health emergencies, such as the COVID-19 pandemic, lead to reduced access to care access and elevated risk of infectious exposures, that disparately impact these women. These secondary effects are even more challenging for underserved and disadvantaged women, for whom the economic and logistic barriers to multiple visits can prove insurmountable. For example, Black women face increased risk of stillbirth as well as of COVID-19 complications, while simultaneously facing more significant barriers to care such as transportation costs, childcare and employment inflexibility. Telehealth solutions have been shown to improve access to prenatal care while reducing racial disparities. Unfortunately, no digital solution has been successfully implemented to enable remote fetal monitoring for high risk pregnancies. Over the past 3 years, we have conducted validation trials of a novel, device and digital platform, called Invu, which uses bio-potential and acoustic sensors to passively detect maternal and fetal heart rate via a wearable, self-administered belt. This platform was just recently approved by the FDA for detecting fetal heart rate as part of a virtual prenatal care visit. However, we recently validated a novel algorithm for detecting uterine contractions using Invu, using the amplitude modulation of maternal signals. The addition of uterine activity monitoring provides Invu with all of the components to remotely conduct a non-stress test (NST), one of the most common fetal surveillance tests used to reduce the risk of stillbirth. However, prior devices have failed to achieve widespread uptake. Thus, it is critical to deploy a deliberate, strategic and multi-faceted approach to implementing a remote NST monitoring solution to maximize its widespread dissemination. We have gathered a multi-disciplinary team of investigators experienced in behavioral and communal interventions, health disparities, innovation methodologies, maternal fetal medicine, clinical trial design and implementation science. We will gather robust stakeholder feedback from patients, providers and clinical team members and utilize the valuable perspective to inform a workflow optimization process using rapid-cycle innovation techniques. This will allow us to preemptively identify and address potential barriers to implementation. We will then conduct a rigorous hybrid, randomized controlled trial that will first focus on demonstrating the effectiveness of a remote NST program to improve patient adherence, with specific attention to ensure that barriers faced by Black women are being addressed. At the same time, we will use a mixed methods strategy, via validated surveys and structured interviews, to study the key factors to widespread implementation and deployment. With 1 million high risk pregnancies delivering annually in the US, an effective remote NST monitoring can have profound positive impact on high risk obstetric health care delivery in the US.