Postpartum hemorrhage (PPH) is the leading cause of maternal death worldwide anddisproportionately affects minority populations. PPH is defined as a large loss of blood within 24 hoursof birth. If detected early enough, effective clinical management solutions exist that significantly reducemortality. Current standard of care for detecting PPH rely on vital sign monitoring and visuallyinspecting the mother's pad to estimate blood loss. However, visual inspection of pads is subjectiveand error prone while deterioration in vital signs are delayed indicators of maternal blood volumechanges. Consequently, early and accurate detection of PPH remains a significant clinical challenge.Vasowatch LLC is developing an automated, continuous, and minimally burdensome monitoringsystem, called the Momitor, that can (1) accurately and rapidly identify symptoms of PPH and (2)deliver real-time and actionable clinical decision support linked to the identified PPH symptoms. TheMomitor system will consist of a wearable device worn on an extremity consisting of LEDs,phototransistors, Wi-Fi radio, and battery. The non-invasive wearable will collectphotoplethysmography (PPG) waveform data, run an algorithm that identifies the onset of waveformchanges suggestive of PPH, and alert clinical staff to assess the mother through a cloud-based systemwith SMS and dashboard alerting capabilities. During PPH the body automatically diverts blood fromnon-vital extremities to vital organs as a lifesaving measure - which delays deterioration in vital signs.Consequently, rather than relying on error-prone visual inspection of sanitary pads and monitoring fordelayed vital sign changes, the Momitor aims to screen for the mother's automatic compensatoryresponse consistent with PPH and hypovolemia. In this Phase I STTR, we will demonstrate proof-of-concept for detecting PPH before vital sign deterioration based on a modified compensatory reserveestimation by demonstrating an algorithm that can accurately detect PPH before existing standard ofcare, prototyping a wearable device that can collect and analyze PPG data for PPH from admissionto 24-hours postpartum. Receipt of NIH funds will allow us to demonstrate proof-of-concept of theMomitor and provide sufficient evidence to pursue FDA Breakthrough Device designation. We believethis solution will address an urgent need and will broadly be appealing to hospitals, resulting in lowercosts and greatly improved outcomes for patients - regardless of race. Expansion into non-hospital-based birth centers will follow.
Public Health Relevance Statement: Project narrative:
Postpartum hemorrhage (PPH) is the leading cause of maternal death worldwide and
disproportionately affects minority populations. If detected early enough, effective clinical
management solutions exist that significantly reduce mortality; however, current standard of care for
detecting PPH are inaccurate and delayed. Vasowatch LLC is developing the Momitor: an automated,
continuous, and minimally burdensome monitoring system that will provide accurate and early
detection of PPH that can save money, save lives, and decrease morbidity across all races and income
levels.
Project Terms:
