Fetal Risk Assessment via Quantified FHR and Uterine Activity Scoring
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Solution Overview
Problem
Current electronic fetal monitoring (EFM) systems lack standardized and objective interpretation of fetal heart rate (FHR) patterns and maternal uterine activity, leading to inconsistent and subjective assessments of fetal risk during labor, which fails to effectively prevent adverse outcomes like hypoxia and acidosis.
Innovation Solution
A method and apparatus that monitor FHR, baseline FHR variability, FHR accelerations, FHR decelerations, and maternal uterine activity to objectively identify non-reassuring characteristics, transforming these parameters into a quantifiable indication of fetal risk, considering both concurrent and antecedent clinical factors to determine the level of risk and recommend appropriate interventions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional EFM interpretation methods are used, then labor can continue when parameters show reassurance, but the interpretation remains subjective and inconsistent leading to poor outcomes
Solution Approach 1:
The patent transforms multiple FHR parameters (rate, variability, accelerations, decelerations) and uterine activity parameters into a standardized risk score system. By changing the interpretation from subjective qualitative assessment to quantitative parameter-based scoring, the system achieves more reliable and consistent fetal risk assessment while maintaining clinical usability.
Solution Approach 2:
The patent divides the complex FHR interpretation into separate independent parameter assessments (FHR rate, variability, accelerations, decelerations, uterine activity). Each parameter is evaluated independently for non-reassuring characteristics, then combined into an overall risk score. This segmentation reduces subjectivity and improves consistency while keeping the system manageable.
2Measurement precision
If multiple FHR parameters are monitored simultaneously, then the ability to detect fetal compromise improves, but the complexity of interpreting the data increases
Solution Approach 1:
The patent monitors five distinct FHR parameters (rate, variability, accelerations, decelerations) and uterine activity separately, evaluating each for specific non-reassuring characteristics. This segmentation allows precise detection of fetal compromise while making interpretation more systematic and less complex by providing clear criteria for each parameter.
Solution Approach 2:
The patent combines multiple independently assessed parameters into a unified fetal risk score. By merging the information from FHR rate, variability, accelerations, decelerations, and uterine activity into a single quantitative risk assessment, the system achieves comprehensive detection precision while simplifying the overall interpretation process.
3Reliability
If all non-reassuring parameters are required before intervention, then false alarms are reduced, but timely intervention for fetal compromise is delayed
Solution Approach 1:
The patent establishes predetermined risk score thresholds that trigger specific intervention recommendations in advance. When the calculated fetal risk score reaches certain levels based on the combination of non-reassuring parameters, the system proactively recommends intervention before severe compromise occurs. This preliminary action framework ensures timely intervention while reducing false alarms through objective scoring criteria.
Data Source
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AI summary
A method for identifying the level of fetal risk during labor comprises monitoring at least each of the concurrent clinical parameters of (a) FHR, (b) baseline FHR variability, (c) FHR accelerations, (d) FHR decelerations, and (e) maternal uterine activity, to determine whether each parameter independently exhibits at least one non- reassuring characteristic, and indicating a present level of risk to the fetus corresponding to the number of the concurrent clinical parameters (a) through (e) that are simultaneously, independently non-reassuring. An apparatus for implementing the method comprises at least one computer operative to receive input signals indicative of at least FHR and maternal uterine activity in a patient. The computer is operative to determine from the FHR baseline FHR variability, FHR accelerations, and FHR decelerations, to determine when any one or more of the parameters (a) through (e) each exhibit at least one non-reassuring characteristic, and to determine a present level of risk to the fetus corresponding to the number of the parameters (a) through (e) that are simultaneously, independently non-reassuring. At least one output operatively connected to the at least one computer indicates the determined present level of risk to the fetus.