By Emily Hamilton, MDCM, Senior Vice President of Clinical Research, PeriGen
Birth-related brain injury, although rare, carries a high rate of devastating consequences for all involved. These consequences can include lifelong disability for the child, family breakdown, multi-million dollar settlements in litigation, and a demoralized medical professional who oftentimes elects to cease obstetrical practice.
An astounding and sad fact is that roughly half of these cases are potentially preventable. The leading issue is a failure to correctly assess the baby’s tolerance to labor based on continuous recordings of fetal heart rate and maternal contractions.
Commercial electronic fetal monitors (EFMs) that produce the continuous recordings of fetal heart rates and contractions were introduced in 1968; today, they are used in almost all births. Hence, how is it possible that a technique in place for nearly half a century is still misused to this degree today? If the answer were simple the problem would have been solved long ago.
The Underlying Problem
Problems with determining when an intervention is required fall into four categories:
Expecting clinicians to make these projections at many points during each labor — and frequently in the middle of the night when human judgment -- is most vulnerable to fatigue, and based on very nonspecific data with generally unhelpful guidelines, creates a “perfect storm” for human error.
Resolving the Perfect Storm
Two decades ago, researchers at McGill University, the leading Medical and Doctoral University in Canada, began a collaboration to address these issues. At that time the university research leaders were highly supportive of developing multidisciplinary teams to find solutions to high impact clinical problems. In studying obstetrical practice challenges, it was clear automated EFM pattern recognition was an essential step to address the issue of human inconsistency and imprecision in tracing analysis. Previously, many groups had tried to develop such software but the exercise had proven difficult to achieve adequate accuracy.
Their top-notch team of mathematicians, engineers, computer scientists and clinicians, aligned by a common mission and abundant persistence, created EFM pattern recognition software that achieved a level of accuracy far exceeding OB reported research findings. This EFM pattern recognition software is embedded today in Cranbury, N.J.-based PeriGen’s fetal surveillance and archiving software PeriCALM® Tracings™. The solution is in clinical use in more than 200 hospitals’ labor and delivery (L&D) departments across the U.S. PeriCALM Patterns is the only fetal strip interpretation technology validated independently and favorably by the National Institutes of Child Health and Development (NICHD). The NICHD study reviewed the analysis of PeriCALM Patterns during the final hour of 100 tracings, and concluded that, “computerized fetal heart rate interpretation has substantial agreement with experts’ evaluation.”
Seeing Results in Real Time
In addition to enhancing clinical efficiency through real-time analysis at the bedside, PeriGen hospital clients have begun to realize tangible benefits such as a substantial drop in uterine tachysystole rates. Uterine tachysystole refers to overly frequent contractions, often caused by the medication oxytocin. Oxytocin, an effective drug to increase the rate and strength of uterine contractions, is used in more than half of all labors. Despite well-established guidelines, incautious use of oxytocin is reported in 45 to 71 percent of births with severe asphyxia and subsequent litigation. Failure to comply with standard oxytocin guidelines generally makes these cases legally indefensible and hence extremely costly.
PeriGen’s PeriCALM Patterns attacks this problem directly via specialized analysis, displays and visual alerts. Clinicians can instantly see onscreen when uterine tachysystole occurs, evaluate how the baby is responding to it, and then see the immediate effects of modified oxytocin dosages.
Brighter Future for Mothers and Babies
OB Research Enters BIg Data Era
Obstetrics medicine has entered today’s “big data” era in which hospitals are amassing vast amounts of electronic patient record data including digital EFM tracings. These massive data sets are essential when studying rare events with multiple contributing factors. Yet they are only part of the solution. An automated method of analysis is also required, because these large data sets cannot be analyzed consistently or precisely with traditional visual inspection.
PeriCALM’s EFM capability has driven a resurgence of research producing a better understanding of EFM characteristics reliably associated with severe neonatal depression or metabolic acidosis. Automated detection of EFM features and the identification of clusters or trends that are truly predictive of poor outcomes would go a long way toward addressing the human inconsistency in bedside care and the devastating consequences it can incur.
The original dream of conducting large-scale studies has materialized. Within the last decade, PeriCALM Patterns and related software have spawned more than two dozen peer reviewed articles. The PeriGen OB solutions are central components in ongoing large studies involving several leading academic medical centers.
Potential clinical impact is also easier to assess. Clinical trials of the size required for rare-outcome research are prohibitively expensive. Retrospective analysis of “big data” is now a realistic alternative to costly classical prospective clinical trials, and in turn can hasten the time to bring research findings to everyday clinical care.
In many ways the historical situation created the conditions of a “perfect storm.” That storm persisted for a very long time because we lacked the tools and data to find better ways. A brighter day is dawning as we now have multiple sophisticated OB tools to counter the obstacles that created the impasse of the past decades as well as tangible evidence of positive results.
Moreover, modern information technology, cloud-based computing and mobile devices can bring these discoveries to assist clinicians in real time at the bedside. Everyone can benefit from the advances gained from rigorous analysis of “big data” now fueling exponential innovation. Stay tuned for more game-changing developments in obstetrical informatics from PeriGen.
Dr. Emily Hamilton directs PeriGen research teams to develop and refine innovative decision support-based fetal monitor technologies designed to prevent birth-related injuries such as shoulder dystocia. Under Dr. Hamilton’s leadership and vision, risk-reduction perinatal technology systems have come of age in obstetrics care practice.