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:

• Fetal Inaccessibility. Clinicians cannot examine the state of baby’s brain in labor, nor measure the amount of oxygen being delivered to it. They can only measure what is accessible — the fetal heart rate — which is a poor substitute for the actual information they need.       
• Inconsistent Visual Analysis. For decades clinicians have examined miles of paper recordings to identify what aspects or features of the tracings are associated with poor outcomes. Thousands of publications ensued. Although there is general agreement on some basic correlations, this methodology stymies any significant advance in reproducible results. Studies will always be limited by the imprecision and inconsistency of inspection with the naked eye as well as confined to relatively small study sizes.
• Impractical Clinical Guidelines. Clinical guidelines on how to classify and manage tracings leave much to be desired. It is impractical and unrealistic to expect clinicians at the bedside to apply complex algorithms based on dozens of rules. A simple three-level system is more manageable and commonly used. Unfortunately, the great majority of tracings reside in the middle level, where abnormalities range from minor to highly abnormal. This simple classification method does not help clinicians chose clinical management because minor midlevel abnormalities require little or no intervention, whereas highly abnormal midlevel changes require urgent intervention. Thus, choosing clinical management for tracing in the “middle” category is akin to deciding what to wear given a nebulous weather forecast of “rain,” which could mean anything from light showers to a hurricane. 
• Poor Projection.  In most diagnostic situations the clinician’s task is to determine whether a condition is present. Correct usage of EFM is far more complex because the objective is to prevent a condition, not wait until diagnosis is certain. That is, clinicians must project what could happen to the baby if the tracing continues or deteriorates. If the baby’s tracing deteriorates, clinicians must determine the length of time the labor could take and at what point before delivery the baby should be removed from the stresses of labor.     

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.