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Changing Perspectives of Electronic Fetal Monitoring
Abstract
The delivery of healthy babies is the primary goal of obstetric care. Many technologies have been developed to reduce both maternal and fetal risks for poor outcomes. For 50 years, electronic fetal monitoring (EFM) has been used extensively in labor attempting to prevent a large proportion of neonatal encephalopathy and cerebral palsy. However, even key opinion leaders admit that EFM has mostly failed to achieve this goal. We believe this situation emanates from a fundamental misunderstanding of differences between screening and diagnostic tests, considerable subjectivity and inter-observer variability in EFM interpretation, failure to address the pathophysiology of fetal compromise, and a tunnel vision focus. To address these suboptimal results, several iterations of increasingly sophisticated analyses have intended to improve the situation. We believe that part of the continuing problem is that the focus of EFM has been too narrow ignoring important contextual issues such as maternal, fetal, and obstetrical risk factors, and increased uterine contraction frequency. All of these can significantly impact the application of EFM to intrapartum care. We have recently developed a new clinical approach, the Fetal Reserve Index (FRI), contextualizing EFM interpretation. Our data suggest the FRI is capable of providing higher accuracy and earlier detection of emerging fetal compromise. Over time, artificial intelligence/machine learning approaches will likely improve measurements and interpretation of FHR characteristics and other relevant variables. Such future developments will allow us to develop more comprehensive models that increase the interpretability and utility of interfaces for clinical decision making during the intrapartum period.
... It is used in around 85% of all labors in the United States [40,44]. However, it is well known that many other risk factors (RFs) are associated with adverse labor outcomes [15]. Some of these risk factors are listed in Fig. 1 and have been classified as maternal, obstetrical, fetal, and delivery risks [15]. ...
... However, it is well known that many other risk factors (RFs) are associated with adverse labor outcomes [15]. Some of these risk factors are listed in Fig. 1 and have been classified as maternal, obstetrical, fetal, and delivery risks [15]. Thus, EFM alone does not address the relationship between risk factors and adverse labor outcomes, and a combination with other RFs has shown drastic improvements in predicting adverse labor outcomes through manual, clinical expert-derived integration in the fetal reserve index (FRI) [15]. ...
... Some of these risk factors are listed in Fig. 1 and have been classified as maternal, obstetrical, fetal, and delivery risks [15]. Thus, EFM alone does not address the relationship between risk factors and adverse labor outcomes, and a combination with other RFs has shown drastic improvements in predicting adverse labor outcomes through manual, clinical expert-derived integration in the fetal reserve index (FRI) [15]. Toward the goal of automating the integration, we describe our first steps in augmenting the clinical expert-derived FRI approach with artificial intelligence (AI) and machine learning (ML) [15]. ...
Early detection of intrapartum risk enables interventions to potentially prevent or mitigate adverse labor outcomes such as cerebral palsy. Currently, there is no accurate automated system to predict such events to assist with clinical decision-making. To fill this gap, we propose "Artificial Intelligence (AI) for Modeling and Explaining Neonatal Health" (AIMEN), a deep learning framework that not only predicts adverse labor outcomes from maternal, fetal, obstetrical, and intrapartum risk factors but also provides the model's reasoning behind the predictions made. The latter can provide insights into what modifications in the input variables of the model could have changed the predicted outcome. We address the challenges of imbalance and small datasets by synthesizing additional training data using Adaptive Synthetic Sampling (ADASYN) and Conditional Tabular Generative Adversarial Networks (CTGAN). AIMEN uses an ensemble of fully-connected neural networks as the backbone for its classification with the data augmentation supported by either ADASYN or CTGAN. AIMEN, supported by CTGAN, outperforms AIMEN supported by ADASYN in classification. AIMEN can predict a high risk for adverse labor outcomes with an average F1 score of 0.784. It also provides counterfactual explanations that can be achieved by changing 2 to 3 attributes on average. Resources available: https://github.com/ab9mamun/AIMEN.
... The majority of neonatal deaths (75%) occur within the first week of life (1, 2). The main objective of obstetric care is the birth of healthy babies, to lower the risks of unfavorable outcomes for both the mother and the fetus, a number of technologies, including EFM, have been developed (3). In an effort to detect fetal oxygen deprivation in its early stages and maybe enable medical personnel to intervene before hypoxic brain impairment occurs, heart rate monitoring is used during delivery (4). ...
... However, EFM has a 99% false-positive rate of fetal hypoxia (4). Continuous EFM is important to prevent neonatal seizure and fetal asphyxia and its complication (3,4,9,10). ...
... FHR decelerations typically result from compression of the fetal head or cord, whereas decelerations in EFM calibrations are typically linked to unthreading of the peripheral chemo-reflex (26,27). One of the most basic ones would be the lack of clarity surrounding the potential applications of EFM, the imprecision of its measurements combined with a significant degree of variability in its interpretation, and the wide range of applications to intrapartum management (3,24). Continuous EFM has associated with high false positive rate which may leads to unnecessary interventions in low risk labor (28); thus, although its usage is justified in high-risk labor, the widespread use of continuous EFM in low risk labor has raised the rates of caesarean and operative vaginal deliveries without improving newborn outcomes (16,29). ...
Background
Electronic fetal heart rate monitoring (EFM) has been widely used in obstetric practice for over 40 years to improve perinatal outcomes. Its popularity is growing in Ethiopia and other sub-Saharan African countries to reduce high perinatal morbidity and mortality rates. However, its impact on delivery mode and perinatal outcomes in low-risk pregnancies remains controversial. This study aimed to assess the effect of continuous EFM on delivery mode and neonatal outcomes among low-risk laboring mothers at Debre Markos Comprehensive Specialized Hospital, Northwest Ethiopia.
Methods
A prospective follow-up study was conducted from November 20, 2023, to January 10, 2024. All low-risk laboring mothers meeting the inclusion criteria were included. Data were collected via pretested structured questionnaires and observation, then analyzed using Epi-data 4.6 and SPSS. The incidences of cesarean delivery and continuous EFM were compared using the chi-squared test and Fisher's exact test.
Results
The study found higher rates of instrumental-assisted vaginal delivery (7% vs. 2.4%) and cesarean sections (16% vs. 2%) due to unsettling fetal heart rate patterns in the continuous EFM group compared to the intermittent auscultation group. However, there were no differences in immediate neonatal outcomes between the groups.
Conclusion
When compared to intermittent auscultation with a Pinard fetoscope, the routine use of continuous EFM among low-risk laboring mothers was associated with an increased risk of cesarean sections and instrumental vaginal deliveries, without significantly improving immediate newborn outcomes. However, it is important to note that our study faced significant logistical constraints due to the limited availability of EFM devices, which influenced our ability to use EFM comprehensively. Given these limitations, we recommend avoiding the routine use of continuous EFM for low-risk laboring mothers to help reduce the rising number of operative deliveries, particularly cesarean sections. Our findings should be interpreted with caution, and further research with adequate resources is needed to draw definitive conclusions.
... With 20 years of hindsight, this publication now appears simplistic because of its dichotomized approach to determine the relationship of labor to CP, and it could not adequately categorize the causes of many CP cases [13][14][15]. For example, the first essential criterion for labor-related CP required that, at birth, the cord pH be < 7.00 and base deficit be ≥ 12mMol/l. ...
... The monograph also concluded that the vast majority of babies that developed CP had prior significant risk factors, and thus concluded their etiology was not attributable to labor. However, numerous such patients entered labor with normal fetal heart rate (FHR) tracings, then subsequently experienced intrapartum problems [14,15]. These women ultimately delivered babies diagnosed with CP for whom there were no obvious genetic abnormalities or other factors to explain such outcomes. ...
... The category system has not solved the problem of how to accurately identify fetuses in danger of developing injuries that, if not receiving intrauterine resuscitation or emergency delivery, will subsequently develop CP. The majority of term babies who develop CP had tracings that remained in category II and never reached category III [14,15,20]. Furthermore, up to 80% of all laboring patients exhibit category II FHR tracings at some point during labor [14][15][16]. ...
Cerebral palsy (CP) has been recognized as a group of neurologic disorders with varying etiologies and ontogenies. While a percentage of CP cases arises during labor, the expanded use of electronic fetal monitoring (EFM) to include prevention of CP has resulted in decades of vastly increased interventions that have not significantly reduced the incidence of CP for infants born at term in the USA. Litigation alleging that poor obstetrical practice caused CP in most of these affected children has led to contentious arguments regarding the actual etiologies of this condition and often resulted in substantial monetary awards for plaintiffs. Recent advances in genetic testing using whole exome sequencing have revealed that at least one-third of CP cases in term infants are genetic in origin and therefore not labor-related. Here, we will present and discuss previous attempts to sort out contributing etiologies and ontogenies of CP, and how these newer diagnostic techniques are rapidly improving our ability to better detect and understand such cases. In light of these developments, we present our vision for an overarching spectrum for proper categorization of CP cases into that the following groups: (1) those begun at conception from genetic causes (nonpreventable); (2) those stemming from adverse antenatal/pre-labor events (possibly preventable with heightened antepartum assessment); (3) Those arising from intrapartum events (potentially preventable by earlier interventions); (4) Those occurring shortly after birth (possibly preventable with closer neonatal monitoring); (5) Those that appear later in the postnatal period from non-labor-related causes such as untreated infections or postnatal intracranial hemorrhages.
... 5,6 Most fundamentally, there has been considerable confusion in how clinicians have really understood what EFM is, namely, whether it is a screening test or a diagnostic test. 4,10,11 Unfortunately, many if not most patients and many physicians do not understand the difference between screening and diagnosis. 4,6 As EFM does not give a definitive diagnosis (eg, fetal death is definitive) in almost all circumstances, Electronic fetal monitoring, particularly in the form of cardiotocography, forms the centerpiece of labor management. ...
... monitoring must be treated as a classic screening test. 5,10,11 Therefore, it must be viewed using the analytical lens that we use for other screening tests. ...
... It did, however, provide only a retrospective assessment of what already happened at best but did not give a prospective road map for risk assessment and how to avoid adverse outcomes. A second edition of this monograph was published in 2014, 46 but there was a continuing problem that the original monograph's rigid cutoffs (pH <7.00) could not account for many cerebral palsy (CP) cases which did not meet the criteria and could not be explained by other factors 10,11,46 (Table 1). ...
Electronic fetal monitoring, particularly in the form of cardiotocography, forms the centerpiece of labor management. Initially successfully designed for stillbirth prevention, there was hope to also include prediction and prevention of fetal acidosis and its sequelae. With the routine use of electronic fetal monitoring, the cesarean delivery rate increased from <5% in the 1970s to >30% at present. Most at-risk cases produced healthy babies, resulting in part from considerable confusion as to the differences between diagnostic and screening tests. Electronic fetal monitoring is clearly a screening test. Multiple attempts have aimed at enhancing its ability to accurately distinguish babies at risk of in utero injury from those who are not and to do this in a timely manner so that appropriate intervention can be performed. Even key electronic fetal monitoring opinion leaders admit that this goal has yet to be achieved. Our group has developed a modified approach called the "Fetal Reserve Index" that contextualizes the findings of electronic fetal monitoring by formally including the presence of maternal, fetal, and obstetrical risk factors and increased uterine contraction frequencies and breaking up the tracing into 4 quantifiable components (heart rate, variability, decelerations, and accelerations). The result is a quantitative 8-point metric, with each variable being weighted equally in version 1.0. In multiple previously published refereed papers, we have shown that in head-to-head studies comparing the fetal reserve index with the American College of Obstetricians and Gynecologists' fetal heart rate categories, the fetal reserve index more accurately identifies babies born with cerebral palsy and could also reduce the rates of emergency cesarean delivery and vaginal operative deliveries. We found that the fetal reserve index scores and fetal pH and base excess actually begin to fall earlier in the first stage of labor than was commonly appreciated, and the fetal reserve index provides a good surrogate for pH and base excess values. Finally, the last fetal reserve index score before delivery combined with early analysis of neonatal heart rate and acid/base balance shows that the period of risk for neonatal neurologic impairment can continue for the first 30 minutes of life and requires much closer neonatal observation than is currently being done.
... These issues have been discussed more extensively in our previous publications. [41][42][43][44][45][46][47][48][49][50][51][52] An effective EFM "screening" protocol can only be created by correlating the pathophysiological relationships between the onset of hypoxia/asphyxia and the pattern of deterioration of the EFM parameters. At its simplest, the analysis of decelerations comes from an assessment of their impact on baseline rate and variability. ...
... Over the past several years we have described a modified approach to the interpretation of EFM built upon the foundations described in this manuscript. [41][42][43][44][45][46][47][48][49][50][51][52] The major philosophical construct underlying our approach is the formal incorporation of specific risk factors and contraction frequency to contextualize the interpretation of EFM. We have developed a new term, the "Fetal Reserve Index" (FRI) which is a weighted calculation of various maternal, fetal, and obstetrical risk factors (MOFR) along with quantitative component FHR interpretation and the presence of increased uterine activity (IUA) ( Table 3). ...
... We have developed a new term, the "Fetal Reserve Index" (FRI) which is a weighted calculation of various maternal, fetal, and obstetrical risk factors (MOFR) along with quantitative component FHR interpretation and the presence of increased uterine activity (IUA) ( Table 3). [41][42][43][44][45][46][47][48][49][50][51][52] The FRI formally includes both antepartum and intrapartum risk factors that contribute to the risk of adverse neurological outcome in the newborn. ...
Since the 1970s, electronic fetal monitoring (EFM) also known as cardiotocography (CTG) has been used extensively in labor around the world, despite its known failure to help prevent many babies from developing neonatal encephalopathy and cerebral palsy. Part of EFM's poor performance with respect to these outcomes arises from a fundamental misunderstanding of the differences between screening and diagnostic tests, subjective classifications of fetal heart rate (FHR) patterns that lead to large inter-observer variability in its interpretation, failure to appreciate early stages of fetal compromise, and poor statistical modeling for its use as a screening test. We have developed a new approach to the practice and interpretation of EFM called the fetal reserve index (FRI) which does the following: (1) breaking FHR components down into 4 components, (heart rate, variability, accelerations, and decelerations); (2) contextualizing the metrics by adding increased uterine activity; (3) adding specific maternal, fetal, and obstetric risk factors. The result is an eight-point scoring metric that, when directly compared with current American College of Obstetricians and Gynecologists EFM categories, even in version 1.0 with equal weighting of variables, shows that the FRI has performed much better for identifying cases at risk before damage had occurred, reducing the need for emergency deliveries, and lowering overall Cesarean delivery rates. With increased data, we expect further refinements in the specifics of scoring that will allow even earlier detection of compromise in labor.
... In obstetrics, electronic fetal monitoring (EFM) or cardiotocography (CTG) has been widely used to monitor uterine contractions and fetal heart rate (FHR) with the aim of assessing fetal well-being during the intrapartum period [8]. FHR assessment has been shown to be effective in reducing the risk of preventable intrapartum fetal death, and in alerting to a large proportion of neonatal complications such as fetal hypoxia, fetal acidemia, neonatal encephalopathy, and cerebral palsy [9]. However, studies carried out on chorioamnionitis have shown contradictory results or an absence of association between FHR and chorioamnionitis [10][11][12][13][14][15]. ...
... As described previously, there is a list of symptoms which help in the clinical diagnosis of chorioamnionitis, but do not have a high predictive value. FHR monitoring is increasingly used in assessing fetal well-being during the intrapartum period, particularly in cases of hypoxia, acidemia and cerebral palsy [9]. However, the relationship between chorioamnionitis and FHR patterns is not yet well established, and previous studies have shown contradictory results. ...
Background
Chorioamnionitis is recognized as a major consequence of preterm premature rupture of membranes (PPROM), and a frequent cause of neonatal morbidity and mortality. The association between fetal heart rate (FHR) and chorioamnionitis remains unclear.
Objectives
The aim of this study was to evaluate the dynamics of FHR in a PPROM population at the approach of delivery according to the presence or absence of chorioamnionitis.
Materials & methods
120 pregnant women with PPROM between 26 and 34 weeks’ gestation were enrolled in this multicenter prospective unblinded study. All participants were fully informed of the study’s objectives. 39 of the 120 patients were included in the analysis of FHR recordings. The analysis consisted of extracting features from computerized FHR analysis (cFHR) and fetal heart rate variability analysis (FHRV) in the temporal, frequency and nonlinear domains. Then, each set of features was analyzed separately using the multiple factor analysis, where three groups were defined as the feature set for days 0, -1 and -2 prior to birth. The distances between the global projection and the projections for each day were computed and used in the ROC analysis to distinguish chorioamnionitis from non-chorioamnionitis group.
Results
The results showed that there were significant differences in certain features between populations with and without chorioamnionitis. The distinction between the two populations reached an area under the curve (AUC) of only 37% [34–40] for cFHR features and 63% [59–66] for time-domain FHRV features when comparing all stages of chorioamnionitis to non-chorioamnionitis subjects. When only stage 3 chorioamnionitis was compared to non-chorioamnionitis patients, the AUC reached 90% [88–93] for nonlinear-domain and 84% [82–87] for time-domain FHRV features, whereas it was limited to 71% [68–74] using cFHR features.
Conclusion
The present study suggests that the HRV features are more reliable for diagnosing chorioamnionitis than cFHR, and that the assessment of features dynamics over several days is an interesting tool for detecting chorioamnionitis. Further study should be carried out on a larger sample to confirm these findings, improve the diagnostic performance of chorioamnionitis and help clinicians decide on delivery criteria.
... Of course, the majority of methods to achieve such never see the light of day, thus allowing for sometimes egregious commentaries to go unchallenged. As an example, over the past several years, our own work has focused on developing a new approach to EFM [101][102][103][104][105][106][107][108][109][110][111][112][113]. It has attacked the very poor performance metrics for EFM that even its own key opinion leaders admit and essentially proposed that various kinds of risk factors and uterine contraction frequency be used to contextualize EFM data and expand the clinical utility of EFM-based predictive models [114][115][116]. ...
... The unifying theme to all these criticisms is that they lead to the primary rejection of the papers with no opportunity to respond to even absurd criticisms. All these papers were eventually published by other reputable journals [101][102][103][104][105][106][107][108][109][110][111][112][113]. If they are looking for it, editors and experienced reviewers can usually distinguish between a legitimate review and "hit jobs." ...
Advances in medical technology do not follow a smooth process and are highly variable. Implementation can occasionally be rapid, but often faces varying degrees of resistance resulting at the very least in delayed implementation. Using qualitative comparative analysis, we have evaluated numerous technological advances from the perspective of how they were introduced, implemented, and opposed. Resistance varies from benign - often happening because of inertia or lack of resources to more active forms, including outright opposition using both appropriate and inappropriate methods to resist/delay changes in care. Today, even public health has become politicized, having nothing to do with the underlying science, but having catastrophic results. Two other corroding influences are marketing pressure from the private sector and vested interests in favor of one outcome or another. This also applies to governmental agencies. There are a number of ways in which papers have been buried including putting the thumb on the scale where reviewers can sabotage new ideas. Unless we learn to harness new technologies earlier in their life course and understand how to maneuver around the pillars of obstruction to their implementation, we will not be able to provide medical care at the forefront of technological capabilities.
... To improve American healthcare, policymakers must facilitate access to care and support public health measures to improve outcomes across the entire population. Approaches might include introducing newer, more precise technologies, altering the structure of incentives across all healthcare and increasing physician control to provide better quality services and make it easier for patients to access care earlier in any disease process [18,[44][45][46]. All require further analysis. ...
Introduction:
The USA has the poorest health statistics of any high-income country. Political polarization has risen dramatically; newer safety net programs (the Affordable Care Act [ACA]) are unevenly provided because many Republican-leaning states refused expanded Federal coverage. Democratic programs have reduced physician leadership of medicine. Both have been deleterious. Here, we investigated associations among four key health measures two of which directly impact pregnancy outcomes and two that affect all patients by percentage of each state that voted for the Republican versus Democratic candidate in the 2020 presidential election.
Methods:
For each state, we used public, non-partisan databases to assess the incidence of COVID, maternal, and infant mortality per 100,000 population and average life expectancy. Correlations among these four outcome variables and percentage Republican vote were calculated (r), contextualized by measuring associations with related variables including COVID vaccination rates, access to medical care, and incidences of heart disease, obesity, diabetes, gunshot deaths, and automotive fatalities.
Results:
COVID mortality, maternal and infant mortality, and life expectancy were highly correlated with percentage Republican ("red") vote per state. If "red" states had vaccination rates equivalent to Democratic-leaning ("blue") states, 72,000 deaths could have been avoided. Overall, "red" states have lower health metrics, reduced access to care, and higher comorbidities.
Conclusion:
The percent Republican vote was strongly associated, but not the whole answer, with worse health outcomes for multiple key measures of public health including mortality, access to care, and various comorbidities. Overall, the ACA has improved patient access to care but has also led to "maternity care deserts" disproportionately in rural areas in "red" states. Translating insurance coverage into improved care and outcomes requires further analysis and will require multi-pronged approaches including expanding coverage and incentivizing quality care.
... In addition, the slow adoption of femtech might be influenced by limited awareness and education [21], doctors' age, years of experience, privacy and security concerns [23], cost and affordability [30], disparities in access to digital technologies [20], global variations in healthcare practices [28], insufficient computer training [29], limited Internet availability in the workplace [30], access to private laptops [21], inadequate infrastructure, absence of appropriate policies [30], varying levels of experience and knowledge among health professionals, organizational factors [22], and due to concerns about reliability and real-world advantages [30]. [42]. ...
... CTG is believed to be capable of detecting fetal abnormal signs, such as hypoxia and acidosis, especially in risk pregnancies. 1 Although the application of cardiotocography (CTG) during childbirth is widely used in developed countries, there is debate about its use in developing countries, especially in improving neonatal outcomes. 2 The latest WHO guidelines do not recommend routine CTG use on admission and continuous CTG during labor for healthy pregnant women. 3 The rationale for this guideline may include the fact that recent studies have shown that the routine use of CTG during delivery increases the cesarean section rate, without significantly reducing fetal or neonatal deaths. ...
Background
The use of cardiotocography (CTG) to improve neonatal outcomes is controversial. The medical settings, subjects, utilizations, and interpretation guidelines of CTG are unclear for low‐ and middle‐income countries (LMICs).
Objectives
To assess and review CTG use for studies identified in LMICs and provide insights on the potential for effective use of CTG to improve maternal and neonatal outcomes.
Search Strategy
The databases Medline, CINAHL, EMBASE, and Cochrane Central Register of Controlled Trials (CENTRAL) were searched for published and unpublished literature through September 2023.
Selection Criteria
Publications were identified which were conducted in LMICs, based on the World Bank list of economies for 2019; targeting pregnant women in childbirth; and focusing on the utilization of CTG and neonatal outcomes.
Data Collection and Analysis
Publications were screened, and duplicates were removed. A scoping review was conducted using PRISMA‐ScR guidelines.
Results
The searches generated 1157 hits, of which 67 studies were included in the review. In the studies there was considerable variation and ambiguity regarding the study settings, target populations, utilizations, timing, frequency, and duration of CTG. While cesarean section rates were extensively investigated as an outcome of studies of CTG itself and the effect of additional techniques on CTG, other clinically significant outcomes, including neonatal mortality, were not well reported.
Conclusions
Variations and ambiguities were found in the use of CTG in LMICs. Due to the limited amount of evidence, studies are needed to examine CTG availability in the context of LMICs.
... Guidelines of NST pattern have been proposed [2][3][4] , which categorized it into three tiers (reactive, atypical and non-reactive). The prenatal NST pattern is typically printed on paper and visually analyzed by obstetricians to detect abnormalities, including low variability, bradycardia, tachycardia, decelerations and sinusoidal patterns [5] . It's demonstrated that accurate interpretation of NST pattern improves neonatal outcomes and avoid unnecessary cesarean section. ...
Objective
To compare interpretation of prenatal non-stress (NST) pattern between obstetricians and artificial intelligence (AI), and to determine the degree of agreement of AI system.
Methods
One thousand records of prenatal NST pattern with 20 to 30 minutes were interpreted using AI system, as well as visual interpretation of five obstetricians, to explore the agreement and accuracy of AI system. Weighted kappa was used to assess reliability of AI for interpretation of prenatal NST pattern.
Results
A total of 967 cases enroll in this study. Moderate agreement (kappa, 0.48) was found among the five obstetricians for FHR pattern during antepartum period. The AI system recognized NST pattern like obstetricians, with a moderate kappa coefficient of agreement of 0.42. When AI was used to assess the strong consistent set of inter-obstetricians, the agreement was high (kappa, 0.75). AI could identify major non-reactive NST pattern, with high sensitivity of 91.67%. A concordant identification was observed 71.76% of preterm cases and 66.05% of term cases.
Conclusion
Based on the visual interpretation of obstetricians, AI was excellent for antepartum FHR monitoring interpretation, regardless gestational age. Further, AI showed a competitive ability to identify non-reactive NST pattern and the potential avoidance of unnecessary clinical intervention.
... Any opinions, findings, conclusions, or recommendations expressed in this material are those of the authors and do not necessarily reflect the views of the funding organization. [6]. Artificial intelligence (AI) and machine learning (ML) hold promise to revolutionize clinical decision-making in general, including in the field of obstetrics [7]. ...
Electronic fetal monitoring (EFM) is designed for the early detection of fetal risks and the prevention of serious neurological impairment but suffers from high false positive rates. The Fetal Reserve Index (FRI) is an expert-based system that combines EFM with maternal, obstetrical, and fetal risk factors and displays superior performance in risk detection than EFM alone. Towards translating the FRI into an automated risk prediction system that can make recommendations to clinicians in real-time, we here develop machine learning classifiers that calculate feature importance based on historical data from labor cases and predict the risk of developing neurological impairment. We train random forest and multilayer perceptron (MLP) models to classify abnormal and normal delivery cases and to assess the model performance using a dataset of 1462 labor cases. The random forest classifier achieves a macro average f-1 score of 0.82 with an abnormal case recall of 0.59. Alternatively, MLP classifiers provide higher abnormal case recall at a cost of lower accuracy and macro average f-1 score. Future work will aim to optimize weightings and trade-offs of statistical performance to achieve further improvements for clinical practice.
... El MEF se ha utilizado ampliamente en el trabajo de parto para prevenir cuadros de encefalopatía neonatal y parálisis cerebral en la mayoría de casos con poco éxito 1 . Proporciona un registro no invasivo de la frecuencia cardíaca fetal (FCF). ...
Introducción: el monitoreo electrónico fetal (MEF) durante el trabajo del parto puede contribuir a la prevención de crisis epilépticas neonatales; su validez en embarazos de bajo riesgo está aún por investigarse. Objetivo: estimar la validez del MEF como predictor de compromiso de bienestar fetal en embarazos de bajo y alto riesgo obstétrico. Metodología: estudio de validación de test diagnóstico. La población estuvo constituida por 412 gestantes con embarazo a término en labor de parto que acudieron a un hospital de tercer nivel de atención en Cuenca – Ecuador, año 2020. Se usó una ficha de recolección de datos fue validado por juicio de expertos. El análisis estadístico se realizó con el programa SPSS 25 con medidas de frecuencias y dispersión central. Para determinar el valor predictivo del MEF se utilizaron sensibilidad (S), especificidad (E), valor predictivo positivo (VPP), valor predictivo negativo (VPN) y curva ROC. Resultados: el MEF en pacientes con riesgo obstétrico alto, como predictor del compromiso de bienestar fetal al minuto, tuvo una S = 30%, VPP = 5%, E = 80.94% y valor VPN 94.93%. Asimismo, el MEF tuvo valor pronóstico bajo, sin significancia estadística (AUC= 0.5537; IC95% 0.4020 – 0.7054; p= 0.0774) para predecir compromiso del bienestar fetal. Conclusiones: el MEF tiene una baja sensibilidad para predecir compromiso de bienestar fetal en embarazos de alto riesgo y su uso en embarazos de bajo riesgo debe evaluar el aumento de intervenciones y el potencial beneficio.
Sixty years ago, the purpose of introducing electronic fetal heart rate monitoring (EFM) was to reduce the incidence of intrapartum stillbirth. However, by the early 1980s, with falling stillbirth rates, fetal blood sampling had been widely abandoned, as many considered that EFM was sufficient on its own. Unfortunately, while the sensitivity of EFM for the detection of potential fetal compromise is high, specificity is low, and there is a high false positive rate which has been associated with a rising cesarean section rate. The authors suggest that EFM is considered and analyzed as a classic screening test and not a diagnostic test. Furthermore, it requires contextualization with other risk factors to achieve improved performance. A new proposed metric, the Fetal Reserve Index, takes into account additional risk factors and has demonstrated significantly improved performance metrics. It is going through the phases of further development, evaluation, and wider clinical implementation.
Introduction -Fetal blood sampling is considered the best option in overcoming the increased false positivity of CTG but is not used in many developing countries due to logistics difficulties. Hence, obstetricians highly rely on CTG for diagnosing fetal hypoxia. Studies of suspicious and pathological CTG correlating with umbilical blood parameters are limited. Lactate can be a reliable marker to assess intrapartum hypoxia. However, the correlation of suspicious and pathological CTG with lactate is least studied. Methodology- A prospective observational cohort study was conducted to correlate suspicious and pathological CTG with umbilical cord arterial blood gas parameters in induced or laboring pregnant women and to compare the maternal and neonatal outcomes. Results - Out of 2350 women subjected to continuous CTG, 104 and 101 participants had suspicious and pathological CTG, respectively. A statistically significant association of CTG was seen in women with preterm delivery and with the use of tramadol. The association of primary outcomes like pH, base excess, and lactate with CTG findings was significant. Discussion - Other modalities to confirm acidosis should be used before an intervention in women with suspicious CTG. Drugs like tramadol and agents used for induction may play a role in abnormal CTG tracing in suspicious CTG. Cord blood lactate has a stronger association with CTG when compared with other umbilical cord parameters. Conclusion- Pathological CTG should be taken cautiously as it carries a greater risk of perinatal distress, but suspicious CTG tracing needs to be supplemented with additional tests before any interventions.
Devices for monitoring heart rate and fetal movement are becoming increasingly sophisticated with the latest technological advancements. However, there is a pressing need for a more comprehensive review and analysis of these tools. The objective of this literature review is to identify fetal health monitoring devices, evaluate the sensitivity of monitoring fetal heart rate and growth/movement, and determine the target users for these devices. Method, the search was conducted using PubMed and Scopus databases, with PICO-based keywords that included pregnant women or pregnancy as the population, fetal or heart rate monitoring tool or fetal movement tool with sensitivity or reactivity as the research interest. A total of 2077 papers were initially identified, with 25 selected after article screening using the PRISMA approach and critical appraisal with JBI. Results, the analysis classified into four categories: the development of monitoring devices for fetal well-being, algorithm for more accurate maternal-fetal FHR filtering, fetal well-being indicators, and target users. The monitoring technology applied wave detection through cardiography and myography. The devices demonstrated a signal sensitivity of more than 75% for both the mother and the fetus. Conclusions, the analysis of the 25 articles revealed that monitoring technology is rapidly evolving, but almost all devices are designed for use by health workers. Only the Piezo Polymer Pressure Sensor is intended for independent monitoring by mothers and families. The development and research of independent fetal monitoring are necessary to improve monitoring during the new adaptation period after the Covid-19 pandemic.KeywordsCovid-19Fetal monitoring toolsFetal Heart rateFetal movementPregnancySensitivity
Over the past 50 years, there have been dramatic advances in both ultrasound and genetic laboratory technologies. The combination of these, not either one alone, has led to an explosion of capabilities to diagnose fetal status earlier in pregnancy. The pace of change is accelerating faster and faster. The major shift in screening from second-trimester ultrasounds and multiple marker biochemical screening of the 1990s to first-trimester nuchal translucency, biochemical, and now cell-free DNA screening has skyrocketed the need for definitive first-trimester diagnostic techniques. However, the actual utilization of such diagnostic techniques has plummeted due to widespread misbelief that noninvasive methods can do “everything” that used to require diagnostic tests such as chorionic villus sampling (CVS) or amniocentesis. In experienced hands, CVS is as safe as amniocentesis; generates far more specimen material for the lab, which decreases errors and turnround time; and allows couples more privacy in their reproductive decisions. Early amniocenteses have come and gone. Preimplantation genetic testing (PGT) in its multiple forms depending upon the type of abnormality being investigated is an excellent screen in high-risk situations, and fetal reduction, particularly when combined with CVS, maximizes the outcomes of multifetal gestations, sometimes allowing couples secondary choices, such as gender preference.KeywordsChorionic villus samplingEarly amniocentesisPreimplantation testingFetal reductionPrenatal diagnosisGender selectionPaternity balancing
Our aim was to evaluate the intra- and inter-operator agreement in cardiotocography (CTG) traces analysis using the 2015 FIGO classification guidelines, and whether the educational background and the knowledge of anamnestic data can influence the interpretation of CTG traces. A retrospective interpretation of 73 intrapartum CTGs at time 0 (T0) for a first blind interpretation and at time 1 (T1) two months later with additional anamnestic pregnancy information was made by eight different operators (four obstetricians and four midwives with different years of work experience). The intra-observer agreement demonstrates that midwifes are more concordant than obstetricians with a mean of 77.05% versus a mean of 65.75%. There is moderate inter-observer agreement in classifying a CTG trace as ‘normal’; on the contrary, there is no consensus on the ‘suspect’ and ‘pathological’ classification category.
• IMPACT STATEMENT
• What is already known on this subject? Interpretation of intrapartum CTG is affected by significant subjective variables with relevant intra- and inter-observer lack of optimal agreement, especially in case of abnormal o pathologic findings.
• What do the results of this study add? Clinical data seem to play a role in interpretation of suspicious and pathological traces while they do not affect the rate of agreement for normal traces. Midwives tend to be less influenced by anamnestic data in visual CTG interpretation. Instead, obstetricians tend to be more focussed on clinical data and clinical setting that, as a consequence, tend to have great impact on CTG trace interpretation.
• What are the implications of these findings for clinical practice and/or further research? Cooperation among obstetricians and between obstetricians and midwives should be encouraged in order to optimise CTG reading and improve maternal and neonatal outcomes. Regarding the influence of clinical parameters in classification of intrapartum CTG traces, especially in case of abnormal CTG traces, it should be conceivable to improve medical skills in CTG blind interpretation and further investigate which clinical parameters are mainly related with an augmented risk of foetal asphyxia and adverse neonatal outcomes.
A review of over 4000+ articles published in 2021 related to artificial intelligence in healthcare.A BrainX Community exclusive, annual publication which has trends, specialist editorials and categorized references readily available to provide insights into related 2021 publications.
Cite as: Mathur P, Mishra S, Awasthi R, Cywinski J, et al. (2022). Artificial Intelligence in Healthcare: 2021 Year in Review. DOI: 10.13140/RG.2.2.25350.24645/1
Objective:
The use of pH and base excess (FSSPHBE) from fetal scalp sampling (FSS) was abandoned when cardiotocography (CTG) was believed to be sufficiently accurate to direct patient management. We sought to understand the fetus' tolerance to stress in the 1st stage of labor and to develop a better and earlier screening test for its risk for developing acidosis. To do so, we investigated sequential changes in fetal pH and BE obtained from FSS in the 1st stage of labor as part of a research protocol from the 1970s. We then examined the utility of multiple of the median (MoM's) conversion of BE and pH values, and the capacity of Fetal Reserve Index (FRI) scores to be a proxy for such changes. We then sought to examine the predictive capacity of 1st stage FRI and its change over the course of the first stage of labor for the subsequent development of acidosis risk in the 2nd stage of labor.
Methods:
Using a retrospective research database evaluation, we evaluated FSSPHBE data from 475 high-risk parturients monitored in labor and their neonates for 1 h postpartum. We categorized specimens according to cervical dilatation (CxD) at the time of FSSPHBE and developed non-parametric, multiples of the median (MOMs) assessments. FRI scores and their change over time were used as predictors of FSSPHBE. Our main outcome measures were the changes in BE and pH at different cervical dilatations (CxD) and acidosis risk in the early 2nd stage of labor.
Results:
FSSPHBE worsens over the course of the 1st stage. The implications of any given BE are very different depending upon CxD. At 9 cm, -8 Mmol/L is 1.1 MOM; at 3 cm, it would be 2.0 MOM. The FRI level and its trajectory provide a 1st stage screening tool for acidosis risk in the second stage.
Conclusions:
Fetal acid-base balance ("reserve") deteriorates beginning early in the 1st stage of labor, irrespective of whether the fetus reaches a critical threshold of concern for actual acidosis. The use of MoM's logic improves appreciation of such information. The FRI and its trajectory reasonably approximate the trajectory of the FSSPHBE and appears to be a suitable screening test for early deterioration and for earlier interventions to keep the fetus out of trouble rather than wait until high risk status develops.
Background
High-quality medical resources are in high demand worldwide, and the application of artificial intelligence (AI) in medical care may help alleviate the crisis related to this shortage. The development of the medical AI industry depends to a certain extent on whether industry experts have a comprehensive understanding of the public’s views on medical AI. Currently, the opinions of the general public on this matter remain unclear.
Objective
The purpose of this study is to explore the public perception of AI in medical care through a content analysis of social media data, including specific topics that the public is concerned about; public attitudes toward AI in medical care and the reasons for them; and public opinion on whether AI can replace human doctors.
Methods
Through an application programming interface, we collected a data set from the Sina Weibo platform comprising more than 16 million users throughout China by crawling all public posts from January to December 2017. Based on this data set, we identified 2315 posts related to AI in medical care and classified them through content analysis.
Results
Among the 2315 identified posts, we found three types of AI topics discussed on the platform: (1) technology and application (n=987, 42.63%), (2) industry development (n=706, 30.50%), and (3) impact on society (n=622, 26.87%). Out of 956 posts where public attitudes were expressed, 59.4% (n=568), 34.4% (n=329), and 6.2% (n=59) of the posts expressed positive, neutral, and negative attitudes, respectively. The immaturity of AI technology (27/59, 46%) and a distrust of related companies (n=15, 25%) were the two main reasons for the negative attitudes. Across 200 posts that mentioned public attitudes toward replacing human doctors with AI, 47.5% (n=95) and 32.5% (n=65) of the posts expressed that AI would completely or partially replace human doctors, respectively. In comparison, 20.0% (n=40) of the posts expressed that AI would not replace human doctors.
Conclusions
Our findings indicate that people are most concerned about AI technology and applications. Generally, the majority of people held positive attitudes and believed that AI doctors would completely or partially replace human ones. Compared with previous studies on medical doctors, the general public has a more positive attitude toward medical AI. Lack of trust in AI and the absence of the humanistic care factor are essential reasons why some people still have a negative attitude toward medical AI. We suggest that practitioners may need to pay more attention to promoting the credibility of technology companies and meeting patients’ emotional needs instead of focusing merely on technical issues.
Education in implementation science, which involves the training of health professionals in how to implement evidence-based findings into health practice systematically, has become a highly relevant topic in health sciences education. The present study advances education in implementation science by compiling a competence profile for implementation practice and research and by exploring implementation experts’ sources of expertise. The competence profile is theoretically based on educational psychology, which implies the definition of improvable and teachable competences. In an online-survey, an international, multidisciplinary sample of 82 implementation experts named competences that they considered most helpful for conducting implementation practice and implementation research. For these competences, they also indicated whether they had acquired them in their professional education, additional training, or by self-study and on-the-job experience. Data were analyzed using a mixed-methods approach that combined qualitative content analyses with descriptive statistics. The participants deemed collaboration knowledge and skills most helpful for implementation practice. For implementation research, they named research methodology knowledge and skills as the most important ones. The participants had acquired most of the competences that they found helpful for implementation practice in self-study or by on-the-job experience. However, participants had learned most of their competences for implementation research in their professional education. The present results inform education and training activities in implementation science and serve as a starting point for a fluid set of interdisciplinary implementation science competences that will be updated continuously. Implications for curriculum development and the design of educational activities are discussed.
An increasing trend in funding towards artificial intelligence (AI) research in medicine has re-animated huge expectations for future applications. Obstetrics and gynaecology remain highly litigious specialities, accounting for a large proportion of indemnity payments due to poor outcomes. Several challenges have to be faced in order to improve current clinical practice in both obstetrics and gynaecology. For instance, a complete understanding of fetal physiology and establishing accurately predictive antepartum and intrapartum monitoring are yet to be achieved. In gynaecology, the complexity of molecular biology results in a lack of understanding of gynaecological cancer, which also contributes to poor outcomes. In this review, we aim to describe some important applications of AI in obstetrics and gynaecology. We also discuss whether AI can lead to a deeper understanding of pathophysiological concepts in obstetrics and gynaecology, allowing delineation of some grey zones, leading to improved healthcare provision. We conclude that AI can be used as a promising tool in obstetrics and gynaecology, as an approach to resolve several longstanding challenges; AI may also be a means to augment knowledge and assist clinicians in decision-making in a variety of areas in obstetrics and gynaecology.
Objective::
Electronic fetal monitoring (EFM) has been used extensively for almost 50 years but performs poorly in predicting and preventing adverse neonatal outcome. In recent years, the current "enhanced" classification of patterns (category I-III system [CAT]) were introduced into routine practice without corroborative studies, which has resulted in even EFM experts lamenting its value. Since abnormalities of arterial cord blood parameters correlate reasonably well with risk of fetal injury, here we compare the statistical performance of EFM using the current CAT system with the Fetal Reserve Index (FRI) for predicting derangements in base excess (BE), pH, and pO2 in arterial cord blood.
Methods::
We utilized a research database of labor data, including umbilical cord blood measurements to assess patients by both worst CAT and last FRI classifications. We compared these approaches for their ability to predict BE, pH, and pO2 in cord blood.
Results::
The FRI showed a clear correlation with cord blood BE and pH with BE being more highly correlated than pH. The CAT was much less predictive than FRI ( P < .05). The CAT II cases had FRI scores across the spectrum of severity of FRI designations and as such provide little clinical discrimination. The PO2 was not discriminatory, in part, because of neonatal interventions.
Conclusions::
The Fetal Reserve Index (FRI) provides superior performance over CAT classification of FHR patterns in predicting the BE and pH in umbilical cord blood. Furthermore, the CAT system fails to satisfy multiple fundamental principles required for successful screening programs. Limitations of CAT are further compounded by assumptions about physiology that are not consistent with clinical observations.
Objective: The cardiotocograph (CTG) or electronic fetal monitoring (EFM) was developed to prevent fetal asphyxia and subsequent neurological injury. From a public health perspective, it has failed these objectives while increasing emergency operative deliveries (emergency operative deliveries (EODs) – emergency cesarean delivery or operative vaginal delivery) for newborns, who in retrospect, actually did not require the assistance. EODs increase the risks of complications and stress for patients, families, and medical personnel. A safe reduction in the need for EOD will likely reduce both the overall Cesarean section rate as well as the risk of fetal neurological injury during labor to which it is related. We have developed the fetal reserve index (FRI), which is more comprehensive than CTG as a new screening method for early identification of the fetus at-risk of both neurological harm and the need to “rescue” by means of an EOD. Here, we compare prospectively the need for EOD in two groups of parturients undergoing a trial of labor at term. One group was managed conventionally, the other by the principles of the FRI.
Study design: We compared the need for EOD of 800 parturients with singleton cases undergoing a trial of labor at term entering with normal CTG patterns (ACOG category 1). Patients were either treated routinely (400 – “early cases”) or in a second group seen later actively managed using the principles of the FRI (400 – “late cases”). The FRI includes measurements of five components of the CTG: rate, variability, decelerations, accelerations, and abnormal uterine activity combined with the presence of medical, obstetrical, and fetal risk factors. The 8-point metric categorizes cases as “green”, “yellow”, and “red” with the latter being at risk.
Results: All 800 patients delivered babies, who were discharged in the usual time course with no untoward outcomes noted. The incidence of red zone scores was comparable in the two groups (≈25%), but the use of intrauterine resuscitation (IR) when reaching the red zone in the late group (47%) was more than double the incidence in the early group (20%) (p < .001). Despite (or because of) this, EODs were significantly reduced in the late group, from 17.3 to 4.0% (p < .001). Further, the late group spent less time in the red zone without increasing overall time in labor. Overall, EOD cases averaged >1 h in the red zone versus 0.5 h for non-EODs.
Conclusions: The FRI may provide a metric to reduce EODs and by extension also reduce the risks of both cesarean delivery and adverse fetal/neonatal outcomes. The safe avoidance of EOD would seem to be an important metric to assess the quality of intrapartum management. This study represents the first attempt to apply the principles of the FRI “live” for the concurrent management of patients during labor. These promising results, if confirmed, in larger sample sizes, set the stage for our computerization of the FRI for widespread study. Benefits appear to come from identification and early, conservative management of fetal deterioration before the need to “rescue” the fetus by EOD.
In this chapter, we provide an overview of the basic principles of teratology, beginning with its definition, the critical point for teratogenesis to occur and the most evident etiological agents to improve the understanding of this science.Teratology is a recent science that began in the early twentieth century, and has greatly improved over the recent years with the advancements in molecular biology, toxicology, animal laboratory science, and genetics, as well as the improvement on the knowledge of the environmental influences.Nevertheless, more work is required to reduce the influence of hazardous products that could be deleterious during pregnancy, thus reducing teratogenic defects in the newborn. While some teratogenic defects are attributed to their agents with certainty, the same for a lot of other such defects is lacking, necessitating consistent studies to decipher the influence of various teratogenic agents on their corresponding teratogenic defects. It is here that the laboratory animal science is of great importance both in the present and in the future.
A half century after continuous electronic fetal monitoring (EFM) became the
omnipresent standard of care for the vastmajority of labors in the developed countries,
and the cornerstone for cerebral palsy litigation, EFM advocates still do not have any
scientific evidence justifying EFM use in most labors or courtrooms. Yet, these EFM
proponents continue rationalizing the procedure with a rhetorical fog of meaningless
words, misleading statistics, archaic concepts, and a complete disregard for medical
ethics. This article illustrates the current state of affairs by providing an evidence-based
review penetrating the rhetorical fog of a prototypical EFM advocate.
Background: Even Key Opinion leaders now concede that electronic fetal monitoring (EFM) cannot reliably identify fetal acidemia which many vouch as the only labor mediated pathophysiologic precursor for cerebral palsy (CP). We have developed the “Fetal Reserve Index” – an algorithm combining five dynamic components of EFM (1. Rate, 2. Variability, 3. Accelerations, 4. Decelerations, and 5. Excessive uterine activity) considered individually that are combined with the presence of: 6. maternal, 7. obstetrical, and 8. fetal risk factors.
Objective: Here, we compare this 8-point fetal reserve index (FRI) against the performance of ACOG monograph criteria and ACOG Category systems for predicting risk for both CP and the need for emergency operative delivery (EOD). We then studied how varied management for screen positives (Red zone- defined below) impacts the outcome of such cases.
Study design: Four hundred twenty term patients were studied: all entered labor with normal EFMs and no apparent cause of harm except events of labor and delivery. Sixty subsequently developed CP, and 360 were apparently normal controls. An FRI, normal on all 8 parameters scored 100%, 4 of 8 was 50%, etc. We divided cases into Green zone > 50%, Yellow 50–26%, and Red ≤ 25%. An FRI in the Red zone was considered a positive screen. We then compared performance metrics for the three evaluation schemes and differences between controls that reached Red against those controls whose worst scores were Green/Yellow.
Results: For detection of injury during labor, the FRI performed much better than the ACOG Category criteria (sensitivity 28%), and Category III (45%) (p < 0.001). All CP cases reached Red zone and were Red for a minimum of 2 hours (mean = 5.35 hours). Twenty-four% of controls reached Red, but were only Red for average of 1 hr. The incidence of low Apgar’s, pH, FRI, and Lowest FRI increased progressively from Green/Yellow controls to red controls to CP cases. Irrespective, CP cases met ACOG Monograph criteria for labor injury less than 50% of the time. Only half of CP babies had umbilical artery pH values < 7.00, and less than 50% showed Category III patterns. The earlier in labor the Red zone was reached, the more likely for a baby to develop CP or the mother to require an EOD regardless of fetal outcome. Successful intrauterine resuscitations (IR) diminished time spent in the Red zone and the need for EODs.
Conclusions: FRI shows better discrimination for adverse fetal outcome and EOD than traditional EFM interpretation. The Category system is a very poor, subjective screening method as the vast majority of CP babies never reach the “action point” result of Category III. While reaching the Red zone does not ordain a bad outcome, how it is managed, does. Compared to CP cases, Red controls were delivered faster, had higher FRIs, and often had prompt management including IR maneuvers which improved the FRI and lowered the risk of EODs even for cases with normal outcomes. With further study and validation, the quantitative FRI approach may replace the current, very subjective interpretation with a quantitative “lab test” approach.
Background:
Continuous electronic fetal heart-rate monitoring is widely used during labour, and computerised interpretation could increase its usefulness. We aimed to establish whether the addition of decision-support software to assist in the interpretation of cardiotocographs affected the number of poor neonatal outcomes.
Methods:
In this unmasked randomised controlled trial, we recruited women in labour aged 16 years or older having continuous electronic fetal monitoring, with a singleton or twin pregnancy, and at 35 weeks' gestation or more at 24 maternity units in the UK and Ireland. They were randomly assigned (1:1) to decision support with the INFANT system or no decision support via a computer-generated stratified block randomisation schedule. The primary outcomes were poor neonatal outcome (intrapartum stillbirth or early neonatal death excluding lethal congenital anomalies, or neonatal encephalopathy, admission to the neonatal unit within 24 h for ≥48 h with evidence of feeding difficulties, respiratory illness, or encephalopathy with evidence of compromise at birth), and developmental assessment at age 2 years in a subset of surviving children. Analyses were done by intention to treat. This trial is completed and is registered with the ISRCTN Registry, number 98680152.
Findings:
Between Jan 6, 2010, and Aug 31, 2013, 47 062 women were randomly assigned (23 515 in the decision-support group and 23 547 in the no-decision-support group) and 46 042 were analysed (22 987 in the decision-support group and 23 055 in the no-decision-support group). We noted no difference in the incidence of poor neonatal outcome between the groups-172 (0·7%) babies in the decision-support group compared with 171 (0·7%) babies in the no-decision-support group (adjusted risk ratio 1·01, 95% CI 0·82-1·25). At 2 years, no significant differences were noted in terms of developmental assessment.
Interpretation:
Use of computerised interpretation of cardiotocographs in women who have continuous electronic fetal monitoring in labour does not improve clinical outcomes for mothers or babies.
Funding:
National Institute for Health Research.
Given evidence that cerebral palsy is not reduced by electronic fetal monitoring, Karin Nelson, Thomas Sartwelle, and Dwight Rouse ask why routine monitoring and related litigation continue to contribute to high rates of caesarean births.
Importance:
Screening for carrier status of a limited number of single-gene conditions is the current standard of prenatal care. Methods have become available allowing rapid expanded carrier screening for a substantial number of conditions.
Objectives:
To quantify the modeled risk of recessive conditions identifiable by an expanded carrier screening panel in individuals of diverse racial and ethnic backgrounds and to compare the results with those from current screening recommendations.
Design, setting, and participants:
Retrospective modeling analysis of results between January 1, 2012, and July 15, 2015, from expanded carrier screening in reproductive-aged individuals without known indication for specific genetic testing, primarily from the United States. Tests were offered by clinicians providing reproductive care.
Exposures:
Individuals were tested for carrier status for up to 94 severe or profound conditions.
Main outcomes and measures:
Risk was defined as the probability that a hypothetical fetus created from a random pairing of individuals (within or across 15 self-reported racial/ethnic categories; there were 11 categories with >5000 samples) would be homozygous or compound heterozygous for 2 mutations presumed to cause severe or profound disease. Severe conditions were defined as those that if left untreated cause intellectual disability or a substantially shortened lifespan; profound conditions were those causing both.
Results:
The study included 346 790 individuals. Among major US racial/ethnic categories, the calculated frequency of fetuses potentially affected by a profound or severe condition ranged from 94.5 per 100 000 (95% CI, 82.4-108.3 per 100 000) for Hispanic couples to 392.2 per 100 000 (95% CI, 366.3-420.2 per 100 000) for Ashkenazi Jewish couples. In most racial/ethnic categories, expanded carrier screening modeled more hypothetical fetuses at risk for severe or profound conditions than did screening based on current professional guidelines (Mann-Whitney P < .001). For Northern European couples, the 2 professional guidelines-based screening panels modeled 55.2 hypothetical fetuses affected per 100 000 (95% CI, 51.3-59.3 per 100 000) and the expanded carrier screening modeled 159.2 fetuses per 100 000 (95% CI, 150.4-168.6 per 100 000). Overall, relative to expanded carrier screening, guideline-based screening ranged from identification of 6% (95% CI, 4%-8%) of hypothetical fetuses affected for East Asian couples to 87% (95% CI, 84%-90%) for African or African American couples.
Conclusions and relevance:
In a population of diverse races and ethnicities, expanded carrier screening may increase the detection of carrier status for a variety of potentially serious genetic conditions compared with current recommendations from professional societies. Prospective studies comparing current standard-of-care carrier screening with expanded carrier screening in at-risk populations are warranted before expanded screening is adopted.
The purpose of this chapter is to assist in the use and interpretation of intrapartum cardiotocography (CTG), as well as in the clinical management of specific CTG patterns. In the preparation of these guidelines, it has been assumed that all necessary resources, both human and material, required for intrapartum monitoring and clinical management are readily available. Unexpected complications may occur during labor, even in patients without prior evidence of risk, so maternity hospitals need to ensure the presence of trained staff, as well as appropriate facilities and equipment for an expedite delivery (in particular emergency cesarean delivery). CTG monitoring should never be regarded as a substitute for good clinical observation and judgement, or as an excuse for leaving the mother unattended during labor.
Objective
Increased frequency of uterine contractions is a component in the cluster of causal conditions that can lead to fetal hypoxia and acidosis and increase the risk for neonatal neurologic injury. For most international obstetrical societies, 5 contractions per 10 min averaged over 30 min is considered as the upper limit of normal uterine activity. We hypothesize that it might be safer to adopt an upper limit of 4 contractions per 10 min.
Methods
We reviewed our 1970’s research database containing 475 patients with closely monitored and well-documented labor and neonatal assessments that included cord blood (CB) pH, base excess (BE), and continuous recording of neonatal heart rate (NHR). Using data segregated by the proportion of the last hour before delivery when uterine contraction frequency (UCF) exceeded 4 and 5 contractions per 10 min respectively, we evaluated outcomes (CB BE, pH, Apgar scores at 1 min, the status of NHR at 16 min after birth, and the proportion of births that did not the result from normal spontaneous vaginal deliveries (NSVDs). ANOVA established relationships between UCF cutoffs and these outcomes. Our sample size is sufficiently large to provide the ability of UCF, per se, to accurately detect an alpha region of .05 88% of the time with an effect size of .15.
Results
During the last hour prior to delivery, a UCF cutoff at 4 contractions per 10 min performed better than a UCF cutoff at 5 contractions per 10 min to enable the earlier identification of risks for abnormal outcomes. The longer UCF was increased, the worse were the outcomes that were measured, and the region >4 but ≤5 contractions identifies the beginnings of worsening conditions in a variety of measures of poor outcomes.
Conclusion
Lowering the recommended threshold for UCF from 5 to 4 contractions per 10-minute period as averaged over 30 min facilitates earlier detection of potentially compromised fetuses and is also an important contributor to a multicomponent contextualized approach to risk assessment.
Objective
The main objective is to study the predictive capacity of intrapartum total fetal reperfusion (fetal resilience) by itself or in combination with other parameters as a predictor of neonatal acidemia.
Study design
A retrospective case-control study was carried out at the Miguel Servet University Hospital (Zaragoza, Spain) on a cohort of 5694 pregnant women between June 2017 and October 2018. Maternal, perinatal, and cardiotocographic records were collected. Two reviewers blindly described the monitors with the American College of Obstetricians and Gynecologists (ACOG) categorizations and parameters and the non-ACOG parameters. Neonatal acidemia was defined as pH <7.10. The parameters analyzed to predict acidemia were evaluated using the sensitivity for specificity 90% value, and the area under the receiver operating characteristic curve.
Results
We recorded 192 infants with acidemia, corresponding to a global acidemia rate of 3.4%. Of these, 72 were excluded for lack of criteria, leaving 120 patients with arterial acidemia included in the study and 258 in the control group. The sensitivity (specificity 90%) of detection of acidemia was 42% for the ACOG III categorization (AUC, 0.524: 95% CI, 0.470–0.578), 24% for fetal reperfusion (AUC, 0.704: 95% CI, 0.649–0.759), 27% for total area of decelerations (AUC, 0.717: 95% CI, 0.664–0.771) and 50% for the multivariate model built from total reperfusion time (AUC, 0.826: 95% CI, 0.783–0.869). The total reperfusion time corresponding to a false negative rate of 10% is 23.75 min, with 28% of fetuses above this time. The AUC and sensitivity for a false negative rate of 10% are equivalent for deceleration area and time of reperfusion (p = .504).
Conclusion
The total reperfusion time (fetal resilience) and total deceleration area are non-ACOG parameters with a good predictive ability for neonatal acidemia, higher than the ACOG III classification and without statistical differences between them. The discrimination ability of total reperfusion time can be improved using a multivariate model. As a cutoff for its use we suggest 23.75 min in 30 min corresponding to an acidemic classification rate of 90%. New parameters in combination with other maternal, obstetrics, or fetal variables, are required for the interpretation of fetal well-being.
Importance:
Cerebral palsy is a common neurodevelopmental disorder affecting movement and posture that often co-occurs with other neurodevelopmental disorders. Individual cases of cerebral palsy are often attributed to birth asphyxia; however, recent studies indicate that asphyxia accounts for less than 10% of cerebral palsy cases.
Objective:
To determine the molecular diagnostic yield of exome sequencing (prevalence of pathogenic and likely pathogenic variants) in individuals with cerebral palsy.
Design, setting, and participants:
A retrospective cohort study of patients with cerebral palsy that included a clinical laboratory referral cohort with data accrued between 2012 and 2018 and a health care-based cohort with data accrued between 2007 and 2017.
Exposures:
Exome sequencing with copy number variant detection.
Main outcomes and measures:
The primary outcome was the molecular diagnostic yield of exome sequencing.
Results:
Among 1345 patients from the clinical laboratory referral cohort, the median age was 8.8 years (interquartile range, 4.4-14.7 years; range, 0.1-66 years) and 601 (45%) were female. Among 181 patients in the health care-based cohort, the median age was 41.9 years (interquartile range, 28.0-59.6 years; range, 4.8-89 years) and 96 (53%) were female. The molecular diagnostic yield of exome sequencing was 32.7% (95% CI, 30.2%-35.2%) in the clinical laboratory referral cohort and 10.5% (95% CI, 6.0%-15.0%) in the health care-based cohort. The molecular diagnostic yield ranged from 11.2% (95% CI, 6.4%-16.2%) for patients without intellectual disability, epilepsy, or autism spectrum disorder to 32.9% (95% CI, 25.7%-40.1%) for patients with all 3 comorbidities. Pathogenic and likely pathogenic variants were identified in 229 genes (29.5% of 1526 patients); 86 genes were mutated in 2 or more patients (20.1% of 1526 patients) and 10 genes with mutations were independently identified in both cohorts (2.9% of 1526 patients).
Conclusions and relevance:
Among 2 cohorts of patients with cerebral palsy who underwent exome sequencing, the prevalence of pathogenic and likely pathogenic variants was 32.7% in a cohort that predominantly consisted of pediatric patients and 10.5% in a cohort that predominantly consisted of adult patients. Further research is needed to understand the clinical implications of these findings.
Objective
Over 5 decades, Cesarean Delivery rates (CDR) have risen 6-fold while vaginal operative deliveries [VODs] decreased from >20% to ∼3%. Poor outcomes (HIE and cerebral palsy) haven’t improved. Potentiating the virtual abandonment of forceps (F), particularly midforceps (Mid), were allegations about various poor neonatal outcomes. Here, we evaluate VOD and CDR outcomes controlling for prior fetal risk metrics (PR) ascertained an hour before birth.
Methods
Our 45-year-old database from a labor research unit of moderate/high risk laboring patients (288 NSVDs, 120 Lows, 30 Mids, and 32 CDs) had multiple fetal scalp samples for base excess (BE), pH, cord blood gases (CB), and umbilical artery bloods. ANOVA established relationships between birth methods and outcomes (Cord blood BE and pH and 1 and 5 min Apgar scores); correlations, and two-step multiple regression assessed PR for delivery method and neonatal outcomes. The main outcome measures were correlations of outcome measures with fetal scalp sample BE and pH up to an hour before delivery and fetal reserve index scores scored concurrently.
Results
NSVDs had the best immediate neonatal outcomes with significantly higher CB pH and BE as compared to forceps and CDs. However, controlling for PR revealed: (1) PR at 1 h before delivery correlated with delivery mode, i.e. the decrements in outcomes were already present before the delivery was performed; and (2) The presumed deleterious effects of interventional deliveries, per se, were significantly reduced, and (3) Fetal Reserve Index predicted neonatal outcomes better than fetal scalp sample BE, pH, or delivery mode.
Conclusion
The historical belief that MF deliveries caused poorer outcomes than NSVDs seems mostly backwards. Appreciating PR’s impact on delivery routes, and when appropriate, properly performing VODs could safely reduce CDR. If our approach lowered CDR by only ∼2%, in the United States about 80,000 CDs might be avoided, saving ∼$750 Million yearly. In the post pandemic world, safely apportioning medical expenses will be even more critical than previously.
Background
It is crucial to interpret the fetal heart rate pattern with a focus on the pattern evolution during labor to estimate the relationship between cerebral palsy and delivery. However, nationwide data are lacking.
Objective
The aim of our study was to demonstrate the features of fetal heart rate pattern evolution and estimate the timing of fetal brain injury during labor in cerebral palsy cases.
Study Design
In this longitudinal study, 1,069 consecutive intrapartum fetal heart rate strips from infants with severe cerebral palsy at or beyond 34 weeks of gestation were analyzed. They were categorized as (i) continuous bradycardia (Bradycardia); (ii) persistently non-reassuring (NR-NR); (iii) reassuring-prolonged deceleration (R-PD); (iv) Hon’s pattern (R-Hon); and (v) persistently reassuring (R-R). The clinical factors underlying cerebral palsy in each group were assessed.
Results
Hypoxic brain injury during labor (R-PD+R-Hon) accounted for 31.5% of severe cases and at least 30% developed during the antenatal period [Bradycardia, 7.86% (n=84); NR-NR, 21.7% (n=232); R-PD, 15.6% (n=167); R-Hon, 15.9% (n=170); R-R, 19.8% (n=212); unclassified, 19.1% (n=204); overall interobserver agreement: moderate (kappa 0.59)]. Placental abruption was the most common cause (31.9%) of cerebral palsy, accounting for almost 90% of cases in the Bradycardia group (n=64/73). Among the cases in the R-Hon group (n=67), umbilical cord abnormalities were the most common clinical factor for cerebral palsy (29.9%), followed by the placental abruption (20.9%) and inappropriate operative vaginal deliveries (13.4%).
Conclusion
Intrapartum hypoxic brain injury accounted for approximately 30% of severe cerebral palsy cases, while a substantial proportion of cases were suspected of having either a prenatal or postnatal onset. Up to 16% of cerebral palsy cases may be preventable with a greater focus on the earlier changes seen with Hon’s fetal heart rate progression.
Objective: Electronic fetal monitoring/ cardiotocography (EFM) is nearly ubiquitous, but nearly everyone acknowledges there is room for improvement. We have contextualized monitoring by breaking it down into quantifiable components and adding to that, other factors that have not been formally used: ie the assessment of uterine contractions, and the presence of maternal, fetal, and obstetrical risk factors. We have created an algorithm, the Fetal Reserve Index (FRI) that significantly improves the detection of at-risk cases. We hypothesized that extending our approach of monitoring to include the immediate newborn period could help us better understand the physiology and pathophysiology of the decrease in fetal reserve during labor and the transition from fetal to neonatal homeostasis, thereby further honing the prediction of outcomes. Such improved and earlier understanding could then potentiate earlier, and more targeted use of neuroprotective attempts during labor treating decreased fetal reserve and improving the fetus’ transition from fetal to neonatal life minimizing risk of neurologic injury.
Study design: We have analyzed a 45-year-old research database of closely monitored labors, deliveries, and an additional hour of continuous neonatal surveillance. We applied the FRI prenatally and created a new metric, the INCHON index that combines the last FRI with umbilical cord blood and 4-minute umbilical artery blood parameters to predict later neonatal acid/base balance. Using the last FRI scores, we created 3 neonatal groups. Umbilical cord and catheterized umbilical artery bloods at 4, 8, 16, 32, and 64 minutes were measured for base excess, pH, and PO2. Continuous neonatal heart rate was scored for rate, variability, and reactivity.
Results: Neonates commonly do not make a smooth transition from fetal to postnatal physiology. Even in low risk babies, 85% exhibited worsening pH and base excess during the first 4 minutes; 34% of neonates reached levels considered at high risk for metabolic acidosis (≤ −12 mmol/L) and neurologic injury. Neonatal heart rate commonly exhibited sustained, significant tachycardia with loss of reactivity and variability. One quarter of all cases would be considered Category III if part of the fetal tracing. Our developed metrics (FRI and INCHON) clearly discriminated and predicted low, medium, and high-risk neonatal physiology.
Conclusions: The immediate neonatal period often imposes generally unrecognized risks for the newborn. INCHON improves identification of decreased fetal reserve and babies at risk, thereby permitting earlier intervention during labor (intrauterine resuscitation) or potentially postnatally (brain cooling) to prevent neurologic injury. We believe that perinatal management would be improved by routine, continuous neonatal monitoring – at least until heart rate reactivity is restored. FRI and INCHON can help identify problems much earlier and more accurately than currently and keep fetuses and babies in better metabolic shape.
Purpose of review:
To review literature about risk factors of neonatal hypoxic-ischemic encephalopathy (HIE).
Recent findings:
Search in PubMed, MEDLINE, Embase, Clinicaltrials.gov and reference lists from 1999 to 2018.
Inclusion criteria:
study population composed of neonates who manifested HIE within 28 days from delivery, data reported as proportional rate. Studies were excluded if they included preterm pregnancies, postnatal conditions leading to HIE and/or fetal malformations, focused on a single risk factor, were not in English language. PRISMA guidelines were followed. Interstudies heterogeneity was assessed and a random/fixed models were generated as appropriate. Comparison between neonates with HIE vs. controls was performed by calculating odds ratio-95% confidence interval (OR-95% CI). Differences were significant if 95% CI did not encompass 1. Twelve articles were included. Fetuses with growth restriction (OR: 2.87; 95% CI: 1.77-4.67), nonreassuring cardiotocography (OR: 6.38; 95% CI: 2.56-15.93), emergency cesarean section (OR: 3.69; 95% CI: 2.75-4.96), meconium (OR: 3.76; 95% CI: 2.58-5.46) and chorioamnionitis (OR: 3.46: 95% CI: 2.07-5.79) were at higher risk of developing HIE. Nulliparity, gestational diabetes, hypertension, oligohydramnios, polyhydramnios, male sex, induction of labor, labor augmentation, premature rupture of membrane, and vacuum delivery were not significantly different.
Summary:
Neonatal HIE has multifactorial origin and its cause is often undetermined and not preventable.PROSPERO (Registration number: CRD42018106563).
Objective: The purpose of this study was to quantify the possible additional risk of a fetus with an isolated choroid plexus cyst (ICPC) for trisomy 21 by combining a large controlled cohort study with data from existent studies.
Methods: We searched our prenatal database between 2000–2014 for all singleton pregnancies between 18 + 0 and 26 + 6 gestational weeks with either an isolated choroid plexus cyst (study group) or no abnormality found in the detailed ultrasound scan (control group). We assessed all prenatal karyotyping results, if an invasive testing was performed, and attempted to collect the postnatal outcome reports of all patients. The prevalence of Down syndrome was calculated. By using previous studies that met our inclusion criteria a meta-analysis following the Bayesian Independent Model was created. From this meta-analysis, we computed the posterior predictive distribution of the probability (trisomy 21 | ICPC) = P1 including posterior means, standard deviations, quantiles (2.5, 50, and 97.5%). By calculating the posterior of the difference (Δ) between the probability (trisomy 21 | ICPC) and the probability (trisomy 21 | Normal Ultrasound) = P2 we investigated the additional risk of an ICPC (ΔB = P1 – P2).
Results: Overall, we detected 1220 fetuses with an isolated plexus cyst at 19–27´ weeks of gestational age (GA). In our study group the prevalence of trisomy 21 was 2/1,220 (0.16, 95% CI: 0.1–0.6%). The median of the pooled probability of trisomy 21 given isolated PC across the studies included in the meta-analysis was 0.2% (CI: 0.1–0.4%). In the given periods (GA and time) 66 606 (74.8%) out of 89 056 investigated fetuses met the inclusion criteria and had a normal ultrasound result without any abnormality. The Δ between our study group and control group was 0.08% (CIΔA: 0–0.5%). Including the meta-analysis the median of the posterior distribution of Δ between P1 and P2 was 0.08% (CIΔB: 0–0.4%) (ΔB = P1 – P2).
Conclusion: The posterior distribution of Δ between P1 and P2 including the meta-analysis corresponds to showing no difference between the cases and controls (95% CIΔB: 0–0.4%). The additional risk of a fetus with an ICPC for trisomy 21 is 97.5% likely to be lower than 0.4% (about 1/250). However, in our collective the positive predictive value of ICPC for Down syndrome was 0.16% (about 1/625). In prenatal counselling the additional risk should be added to the individual risk (based on maternal age, earlier screening test results and sonographic markers) and the diagnostic options including fetal DNA and diagnostic procedures should be discussed according to the posterior individual risk.
Background:
Although the evidence regarding the benefit of using ST waveform analysis of the fetal electrocardiogram is conflicting, ST waveform analysis is considered as adjunct to identify fetuses at risk for asphyxia in our center. Most randomized controlled trials and meta-analyses have not shown a significant decrease in umbilical metabolic acidosis while some observational studies have shown a gradual decrease of this outcome over a longer period of time. Observational studies can give more insight into the effect of implementation of the ST technology in daily clinical practice.
Objective:
To evaluate the change in frequency of perinatal intervention and adverse neonatal outcome after the implementation of ST waveform analysis of the fetal electrocardiogram from 2000 to 2013.
Study design:
This retrospective longitudinal study was conducted in a tertiary referral center. A total of 19,664 medium- and high-risk singleton pregnancies with fetuses in cephalic presentation, a gestational age of ≥36 weeks and the intention to deliver vaginally were included. ST waveform analysis of the fetal electrocardiogram was implemented in the year 2000 and by 2010 all deliveries were monitored using this technology. Data was collected on the following perinatal outcomes: fetal blood sampling, mode of delivery, umbilical cord blood gases, Apgar scores, neonatal encephalopathy and perinatal death. Longitudinal trend analysis was used to detect changes over time in all deliveries monitored by either CTG alone or in adjunct to ST waveform analysis of the fetal electrocardiogram. Logistic regression was used to correct for possible confounders.
Results:
The umbilical artery metabolic acidosis rate declined from 2.5% (average rate of 2000+2001+2002) to 0.4% (average of 2011+2012+2013) (p<0.001), which represents an 84% decrease. This decrease largely occurred between 2006 and 2008, during the Dutch randomized trial on fetal electrocardiogram ST waveform analysis. At this time, approximately 20% of deliveries were monitored using this method. Furthermore, there were significant reductions in fetal blood sampling rate (p<0.001). Overall cesarean and vaginal instrumental deliveries decreased significantly (p<0.001), but not for fetal distress. There were no changes in the Apgar scores. The incidence of neonatal encephalopathy was significantly lower in the second part of the study (OR 0.39, 95% CI 0.17-0.89).
Conclusion:
There was an 84% decrease in the incidence of umbilical artery metabolic acidosis in all deliveries between 2000 and 2013. The neonatal encephalopathy rate, fetal blood sampling rate and the total number of cesarean and vaginal instrumental deliveries also decreased.
Electronic fetal monitoring (EFM) is a poor predictor of outcomes attributable to delivery problems. Contextualizing EFM by adding maternal, obstetrical, and fetal risk-related information to create an index called the Fetal Reserve Index (FRI) improves the predictive capacity and facilitates the timing of interventions. Here, we test critical assumptions of FRI as a clinical tool. Our conceptualization implies that the earlier one reaches the red zone (FRI ≤25) and the longer one spends in the red zone, the greater the likelihood of emergency operative deliveries (EOD).
Methods:
We analyzed 1,402 patients using logistic regression predicting the probability of EOD and employed qualitative methodology techniques to refine predictive capabilities.
Results:
Reaching the red zone early and staying there > 1 h increases the probability of EOD. When these risk factors are paired with intrauterine resuscitation (IR) in Stage 1, the reduction of EOD is substantial.
Conclusion:
FRI is a capable predictor of EOD because it accurately identifies the level of malleable risk. FRI analysis increases the risk of using IR in Stage 1. Matching risk and resources dramatically reduces the chances of EOD. Earlier IR improves the outcomes if the calculated risk is high.
Objective:
To assess the implications of increasing utilization of noninvasive prenatal screening (NIPS), which may reach 50% with the concomitant decrease in diagnostic procedures (DPs) for its impact on detection of chromosomal abnormalities.
Methods:
We studied our program's statistics over 5 years for DPs and utilization of array comparative genomic hybridization (aCGH). We then modeled the implications in our program if DP had not fallen and nationally of a 50% DP and aCGH testing rate using well-vetted expectations for the diagnosis of abnormal copy number variants (CNVs).
Results:
Our DP fell 40% from 2013-2017. Utilization of aCGH for DP nearly tripled. We detected 28 abnormal CNVs. If DP had not fallen, we likely would have detected 60. With 4 million US births per year, 2 million DPs would detect 30 000 abnormal CNVs and 4000 standard aneuploidies. At a 1/500 complication-pregnancy loss rate, the detection/complication ratio is 8.5/1.
Conclusions:
Noninvasive prenatal screening has significantly changed the practice of prenatal screening. However, while increasing the detection of Down syndrome, the concomitant decrease in DP and lack of aCGH results in missing many more abnormalities than the increase in Down syndrome and complications of DP combined. From a public health perspective, such represents a missed opportunity for overall health care delivery.
Prenatal whole exome sequencing (WES) has the potential to increase the ability to provide more diagnostic capabilities in fetuses with sonographic abnormalities, which would then improve the ability to counsel families. It is also often the first step in improving the path toward informed diagnosis and treatment, which is especially important in the era of advancing in utero fetal therapy. This article discusses the current literature regarding prenatal WES, clinical indications for WES, challenges with interpretation/counseling (variants of unknown significance), research priorities, ethical issues, and potential future advances.
The launch of the United Nations Sustainable Development Goals and the new Secretary General's Global Strategy for Women's, Children's, and Adolescents' Health are a window of opportunity for improving the health and well-being of women, children, and adolescents in the United States and around the world. Realizing the full potential of this historic moment will require that we improve our ability to successfully implement life-saving and life-enhancing innovations, particularly in low-resource settings. Implementation science, a new and rapidly evolving field that addresses the "how-to" component of providing sustainable quality services at scale, can make an important contribution on this front. A synthesis of the implementation science evidence indicates that three interrelated factors are required for successful, sustainable outcomes at scale: 1) effective innovations, 2) effective implementation, and 3) enabling contexts. Implementation science addresses the interaction among these factors to help make innovations more usable, to build ongoing capacity to assure the effective implementation of these innovations, and to ensure enabling contexts to sustain their full and effective use in practice. Improving access to quality services will require transforming health care systems and, therefore, much of the focus of implementation science in global health is on improving the ability of health systems to serve as enabling contexts. The field of implementation science is inherently interdisciplinary and academe will need to respond by facilitating collaboration among scientists from relevant disciplines, including evaluation, improvement, and systems sciences. Platforms and programs to facilitate collaborations among researchers, practitioners, policymakers, and funders are likewise essential.
The “best interests of the patient” standard—a complex balance between the principles of beneficence and autonomy—is the driving force of ethical clinical care. Clinicians’ fear of litigation is a challenge to that ethical paradigm. But is it ever ethically appropriate for clinicians to undertake a procedure with the primary goal of protecting themselves from potential legal action? Complicating that question is the fact that tort liability is adjudicated based on what most clinicians are doing, not the scientific basis of whether they should be doing it in the first place. In a court of law, clinicians are generally judged based on the “reasonably prudent” standard: what a reasonably prudent practitioner in a similar situation would do. But this legal standard can have the effect of shifting the medical standard of care—enabling a standard‐of‐care sprawl where actions undertaken for the primary purpose of avoiding liability reset the standard of care against which clinicians will be adjudicated. While this problem has been recognized in the legal literature, neither current ethical models of care nor legal theory offer workable solutions .
One of the best examples of the conflict between evidence‐based medicine and common clinical practice is the use of electronic fetal monitoring. Despite strong evidence and professional guidelines that argue against the use of EFM for healthy pregnancies, the practice persists. One of the main reasons for this is often assumed to be physicians’ concerns about liability .
( Am J Obstet Gynecol . 2017;216(2):163.e1–163.e6)
While unexpected intrapartum fetal death has largely been eliminated with the use of electronic fetal heart rate monitoring (EFHRM), the goal of consistently preventing hypoxia-induced fetal metabolic acidemia has proven difficult. Moreover, the impact of EFHRM on long-term neonatal outcomes is not well documented, as the potential impact of monitoring conditions on outcomes with multifactorial origins (such as cerebral palsy) is so small as never to have been statistically demonstrated. The present outcomes-blinded case control study had 3 aims: to determine why infants were born with significant metabolic acidemia despite the use of EFHRM, to evaluate the potential impact of a previously published algorithm on these outcomes, and to consider the limits of EFHRM in the prevention of neonatal metabolic acidemia.
Objective:
The near-ubiquitous use of electronic fetal monitoring has failed to lower the rates of both cerebral palsy and emergency operative deliveries (EODs). Its performance metrics have low sensitivity, specificity, and predictive values for both. There are many EODs, but the vast majority have normal outcomes. The EODs, however, cause serious disruption in the delivery suite routine with increased complications, anxiety, and concern for all.
Methods:
We developed the fetal reserve index (FRI) as multicomponent algorithm including 4 FHR components (analyzed individually), uterine activity, and maternal, obstetrical, and fetal risk factors to assess risk of cerebral palsy and EOD. Scores were categorized into green, yellow, and red zones. Here, we studied 300 patients by the FRI, all of whom had normal neonatal outcomes. We attempted to distinguish the clinical course of those cases which required an EOD versus controls which did not.
Results:
51 cases with EOD had FRIs much lower than 249 non-EOD cases. The red zone was reached more frequently ( P < .001) and lasted longer (1.06 vs 0.05 hours; P < .001). Reaching the red zone had a sensitivity of 92% for EOD, with a positive predictive value of 64% and a false positive rate of 10.4%.
Conclusions:
Our data suggest the FRI can significantly lower the incidence of EODs by identifying the opportunity for intrauterine resuscitation. Our approach can reduce the disruptive effects of EODs and their concomitant increased risks of complications. The FRI may provide a metric that can refine labor management to reduce CP and EODs.
Objective:
Electronic fetal monitoring (EFM) correlates poorly with neonatal outcome. We present a new metric: the "Fetal Reserve Index" (FRI), formally incorporating EFM with maternal, obstetrical, fetal risk factors, and excessive uterine activity for assessment of risk for cerebral palsy (CP).
Methods:
We performed a retrospective, case-control series of 50 term CP cases with apparent intrapartum neurological injury and 200 controls. All were deemed neurologically normal on admission. We compared the FRI against ACOG Category (I-III) system and long-term outcome parameters against ACOG monograph (NEACP) requirements for labor-induced fetal neurological injury.
Results:
Abnormal FRI's identified 100% of CP cases and did so hours before injury. ACOG Category III identified only 44% and much later. Retrospective ACOG monograph criteria were found in at most 30% of intrapartum-acquired CP patients; only 27% had umbilical or neonatal pH <7.0.
Conclusions:
In this initial, retrospective trial, an abnormal FRI identified all cases of labor-related neurological injury more reliably and earlier than Category III, which may allow fetal therapy by intrauterine resuscitation. The combination of traditional EFM with maternal, obstetrical, and fetal risk factors creating the FRI performed much better as a screening test than EFM alone. Our quantified screening system needs further evaluation in prospective trials.
Background:
Cardiotocography (CTG) records changes in the fetal heart rate and their temporal relationship to uterine contractions. The aim is to identify babies who may be short of oxygen (hypoxic) to guide additional assessments of fetal wellbeing, or determine if the baby needs to be delivered by caesarean section or instrumental vaginal birth. This is an update of a review previously published in 2013, 2006 and 2001.
Objectives:
To evaluate the effectiveness and safety of continuous cardiotocography when used as a method to monitor fetal wellbeing during labour.
Search methods:
We searched the Cochrane Pregnancy and Childbirth Group Trials Register (30 November 2016) and reference lists of retrieved studies.
Selection criteria:
Randomised and quasi-randomised controlled trials involving a comparison of continuous cardiotocography (with and without fetal blood sampling) with no fetal monitoring, intermittent auscultation intermittent cardiotocography.
Data collection and analysis:
Two review authors independently assessed study eligibility, quality and extracted data from included studies. Data were checked for accuracy.
Main results:
We included 13 trials involving over 37,000 women. No new studies were included in this update.One trial (4044 women) compared continuous CTG with intermittent CTG, all other trials compared continuous CTG with intermittent auscultation. No data were found comparing no fetal monitoring with continuous CTG. Overall, methodological quality was mixed. All included studies were at high risk of performance bias, unclear or high risk of detection bias, and unclear risk of reporting bias. Only two trials were assessed at high methodological quality.Compared with intermittent auscultation, continuous cardiotocography showed no significant improvement in overall perinatal death rate (risk ratio (RR) 0.86, 95% confidence interval (CI) 0.59 to 1.23, N = 33,513, 11 trials, low quality evidence), but was associated with halving neonatal seizure rates (RR 0.50, 95% CI 0.31 to 0.80, N = 32,386, 9 trials, moderate quality evidence). There was no difference in cerebral palsy rates (RR 1.75, 95% CI 0.84 to 3.63, N = 13,252, 2 trials, low quality evidence). There was an increase in caesarean sections associated with continuous CTG (RR 1.63, 95% CI 1.29 to 2.07, N = 18,861, 11 trials, low quality evidence). Women were also more likely to have instrumental vaginal births (RR 1.15, 95% CI 1.01 to 1.33, N = 18,615, 10 trials, low quality evidence). There was no difference in the incidence of cord blood acidosis (RR 0.92, 95% CI 0.27 to 3.11, N = 2494, 2 trials, very low quality evidence) or use of any pharmacological analgesia (RR 0.98, 95% CI 0.88 to 1.09, N = 1677, 3 trials, low quality evidence).Compared with intermittent CTG, continuous CTG made no difference to caesarean section rates (RR 1.29, 95% CI 0.84 to 1.97, N = 4044, 1 trial) or instrumental births (RR 1.16, 95% CI 0.92 to 1.46, N = 4044, 1 trial). Less cord blood acidosis was observed in women who had intermittent CTG, however, this result could have been due to chance (RR 1.43, 95% CI 0.95 to 2.14, N = 4044, 1 trial).Data for low risk, high risk, preterm pregnancy and high-quality trials subgroups were consistent with overall results. Access to fetal blood sampling did not appear to influence differences in neonatal seizures or other outcomes.Evidence was assessed using GRADE. Most outcomes were graded as low quality evidence (rates of perinatal death, cerebral palsy, caesarean section, instrumental vaginal births, and any pharmacological analgesia), and downgraded for limitations in design, inconsistency and imprecision of results. The remaining outcomes were downgraded to moderate quality (neonatal seizures) and very low quality (cord blood acidosis) due to similar concerns over limitations in design, inconsistency and imprecision.
Authors' conclusions:
CTG during labour is associated with reduced rates of neonatal seizures, but no clear differences in cerebral palsy, infant mortality or other standard measures of neonatal wellbeing. However, continuous CTG was associated with an increase in caesarean sections and instrumental vaginal births. The challenge is how best to convey these results to women to enable them to make an informed decision without compromising the normality of labour.The question remains as to whether future randomised trials should measure efficacy (the intrinsic value of continuous CTG in trying to prevent adverse neonatal outcomes under optimal clinical conditions) or effectiveness (the effect of this technique in routine clinical practice).Along with the need for further investigations into long-term effects of operative births for women and babies, much remains to be learned about the causation and possible links between antenatal or intrapartum events, neonatal seizures and long-term neurodevelopmental outcomes, whilst considering changes in clinical practice over the intervening years (one-to-one-support during labour, caesarean section rates). The large number of babies randomised to the trials in this review have now reached adulthood and could potentially provide a unique opportunity to clarify if a reduction in neonatal seizures is something inconsequential that should not greatly influence women's and clinicians' choices, or if seizure reduction leads to long-term benefits for babies. Defining meaningful neurological and behavioural outcomes that could be measured in large cohorts of young adults poses huge challenges. However, it is important to collect data from these women and babies while medical records still exist, where possible describe women's mobility and positions during labour and birth, and clarify if these might impact on outcomes. Research should also address the possible contribution of the supine position to adverse outcomes for babies, and assess whether the use of mobility and positions can further reduce the low incidence of neonatal seizures and improve psychological outcomes for women.
What is already known about this topic:
• Innovation and technological development have commonalities across all disciplines in terms of process, evaluation, and incorporation into use.
• Many technologies have evolved through traditional methods such as research grant funding, individual and multicenter trials, followed by eventual introduction into common practice. Others have been significantly sped up by industrial resources and drive.
What this study adds:
• The development of basic new concepts and procedures will very like continue to reside the academic environment.
• As the pace of technological development has rapidly accelerated and academic support for such work has significantly diminished, corporate involvement, sponsorship, and partnering have become much more common and, particularly for laboratory techniques, are necessary to achieve progress at a rapid pace.
• There is a balance that needs to be respected between the benefits and constraints of such industrial involvement that will require compromise on both sides to achieve an optimal environment.
Background:
Despite intensive efforts directed at initial training in fetal heart rate interpretation, continuing medical education, board certification/recertification, team training, and the development of specific protocols for the management of abnormal fetal heart rate patterns, the goals of consistently preventing hypoxia-induced fetal metabolic acidemia and neurologic injury remain elusive.
Objective:
The purpose of this study was to validate a recently published algorithm for the management of category II fetal heart rate tracings, to examine reasons for the birth of infants with significant metabolic acidemia despite the use of electronic fetal heart rate monitoring, and to examine critically the limits of electronic fetal heart rate monitoring in the prevention of neonatal metabolic acidemia.
Study design:
The potential performance of electronic fetal heart rate monitoring under ideal circumstances was evaluated in an outcomes-blinded examination fetal heart rate tracing of infants with metabolic acidemia at birth (base deficit, >12) and matched control infants (base deficit, <8) under the following conditions: (1) expert primary interpretation, (2) use of a published algorithm that was developed and endorsed by a large group of national experts, (3) assumption of a 30-minute period of evaluation for noncritical category II fetal heart rate tracings, followed by delivery within 30 minutes, (4) evaluation without the need to provide patient care simultaneously, and (5) comparison of results under these circumstances with those achieved in actual clinical practice.
Results:
During the study period, 120 infants were identified with an arterial cord blood base deficit of >12 mM/L. Matched control infants were not demographically different from subjects. In actual practice, operative intervention on the basis of an abnormal fetal heart rate tracings occurred in 36 of 120 fetuses (30.0%) with metabolic acidemia. Based on expert, algorithm-assisted reviews, 55 of 120 patients with acidemia (45.8%) were judged to need operative intervention for abnormal fetal heart rate tracings. This difference was significant (P=.016). In infants who were born with a base deficit of >12 mM/L in which blinded, algorithm-assisted expert review indicated the need for operative delivery, the decision for delivery would have been made an average of 131 minutes before the actual delivery. The rate of expert intervention for fetal heart rate concerns in the nonacidemic control group (22/120; 18.3%) was similar to the actual intervention rate (23/120; 19.2%; P=1.0) Expert review did not mandate earlier delivery in 65 of 120 patients with metabolic acidemia. The primary features of these 65 cases included the occurrence of sentinel events with prolonged deceleration just before delivery, the rapid deterioration of nonemergent category II fetal heart rate tracings before realistic time frames for recognition and intervention, and the failure of recognized fetal heart rate patterns such as variability to identify metabolic acidemia.
Conclusions:
Expert, algorithm-assisted fetal heart rate interpretation has the potential to improve standard clinical performance by facilitating significantly earlier recognition of some tracings that are associated with metabolic acidemia without increasing the rate of operative intervention. However, this improvement is modest. Of infants who are born with metabolic acidemia, only approximately one-half potentially could be identified and have delivery expedited even under ideal circumstances, which are probably not realistic in current US practice. This represents the limits of electronic fetal heart rate monitoring performance. Additional technologies will be necessary if the goal of the prevention of neonatal metabolic acidemia is to be realized.
( Am J Obstet Gynecol. 2015;213(3):257–258)
When a child is delivered, it is important to be able to find objective measures which can be obtained at birth to accurately inform an obstetrician as to whether the infant is healthy and if that infant has any increased risk factors for future morbidities. An example of such a marker is hypoxic ischemic encephalopathy, which serves as an indicator from the neonatal period for cerebral palsy. For many years, infant risk for hypoxic ischemic encephalopathy has been assessed by measuring pH at birth. However, many have questioned whether there might be better indicators, such as a large base deficit or lactate. Others have raised the equally important question of whether any of these indicators are in fact reliable.
Developmental studies were done at 3 and 4 years of age in a series of 656 children and the results were correlated with the preceding labor pattern and the type of delivery. It was determined that there were significant adverse effects among offspring delivered by midforceps procedures or born following labors characterized by prolonged deceleration, secondary arrest of dilatation, or arrest of descent.
In the most recent year for which data are available, approximately 3.4 million fetuses (85% of approximately 4 million live births) in the United States were assessed with electronic fetal monitoring (EFM), making it the most common obstetric procedure (1). Despite its widespread use, there is controversy about the efficacy of EFM, interobserver and intraobserver variability, nomenclature, systems for interpretation, and management algorithms. Moreover, there is evidence that the use of EFM increases the rate of cesarean deliveries and operative vaginal deliveries. The purpose of this document is to review nomenclature for fetal heart rate assessment, review the data on the efficacy of EFM, delineate the strengths and shortcomings of EFM, and describe a system for EFM classification. Copyright © July 2009 by the American College of Obstetricians and Gynecologists.
It is unclear whether using fetal electrocardiographic (ECG) ST-segment analysis as an adjunct to conventional intrapartum electronic fetal heart-rate monitoring modifies intrapartum and neonatal outcomes.
We performed a multicenter trial in which women with a singleton fetus who were attempting vaginal delivery at more than 36 weeks of gestation and who had cervical dilation of 2 to 7 cm were randomly assigned to "open" or "masked" monitoring with fetal ST-segment analysis. The masked system functioned as a normal fetal heart-rate monitor. The open system displayed additional information for use when uncertain fetal heart-rate patterns were detected. The primary outcome was a composite of intrapartum fetal death, neonatal death, an Apgar score of 3 or less at 5 minutes, neonatal seizure, an umbilical-artery blood pH of 7.05 or less with a base deficit of 12 mmol per liter or more, intubation for ventilation at delivery, or neonatal encephalopathy.
A total of 11,108 patients underwent randomization; 5532 were assigned to the open group, and 5576 to the masked group. The primary outcome occurred in 52 fetuses or neonates of women in the open group (0.9%) and 40 fetuses or neonates of women in the masked group (0.7%) (relative risk, 1.31; 95% confidence interval, 0.87 to 1.98; P=0.20). Among the individual components of the primary outcome, only the frequency of a 5-minute Apgar score of 3 or less differed significantly between neonates of women in the open group and those in the masked group (0.3% vs. 0.1%, P=0.02). There were no significant between-group differences in the rate of cesarean delivery (16.9% and 16.2%, respectively; P=0.30) or any operative delivery (22.8% and 22.0%, respectively; P=0.31). Adverse events were rare and occurred with similar frequency in the two groups.
Fetal ECG ST-segment analysis used as an adjunct to conventional intrapartum electronic fetal heart-rate monitoring did not improve perinatal outcomes or decrease operative-delivery rates. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and Neoventa Medical; ClinicalTrials.gov number, NCT01131260.).
Complications occurring at any level of foetal oxygen supply will result in hypoxaemia, and this may ultimately lead to hypoxia/acidosis and neurological damage. Hypoxic-ischaemic encephalopathy (HIE) is the short-term neurological dysfunction caused by intrapartum hypoxia/acidosis, and this diagnosis requires the presence of a number of findings, including the confirmation of newborn metabolic acidosis, low Apgar scores, early imaging evidence of cerebral oedema and the appearance of clinical signs of neurological dysfunction in the first 48 h of life. Cerebral palsy (CP) consists of a heterogeneous group of nonprogressive movement and posture disorders, frequently accompanied by cognitive and sensory impairments, epilepsy, nutritional deficiencies and secondary musculoskeletal lesions. Although CP is the most common long-term neurological complication associated with intrapartum hypoxia/acidosis, >80% of cases are caused by other phenomena. Data on minor long-term neurological deficits are scarce, but they suggest that less serious intellectual and motor impairments may result from intrapartum hypoxia/acidosis. This chapter focuses on the existing evidence of neurological damage associated with poor foetal oxygenation during labour.
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In April 2008, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the American College of Obstetricians and Gynecologists, and the Society for Maternal-Fetal Medicine partnered to sponsor a 2-day workshop to revisit nomenclature, interpretation, and research recommendations for intrapartum electronic fetal heart rate monitoring. Participants included obstetric experts and representatives from relevant stakeholder groups and organizations. This article provides a summary of the discussions at the workshop. This includes a discussion of terminology and nomenclature for the description of fetal heart tracings and uterine contractions for use in clinical practice and research. A three-tier system for fetal heart rate tracing interpretation is also described. Lastly, prioritized topics for future research are provided.