We are developing a non-invasive neonatal monitoring device to continue monitoring of the fetus during the first 30-60 minutes postpartum. We monitor critical physiological parameters such as oxygenation, heart rate, and skin pH. These are crucial for the early identification of potential health issues in newborns, including hypoxia and acidosis which are forerunners of neonatal encephalopathy and cerebral palsy. An ESP32 microcontroller and MAX30102 sensor are integrated within a wearable, sock form factor. We address limitations of traditional invasive neonatal monitors by providing continuous, real-time health assessment through seamless wireless connectivity, including Bluetooth compatibility. The project not only focuses on the technological development of the device but also emphasizes the importance of a non-invasive monitoring design for comfort and precise diagnostics for informed healthcare interventions. This project underscores the critical role of early detection and intervention for neonatal compromise, to potentially transform neonatal health monitoring and improve outcomes for newborn infants worldwide.
Inherent in healthcare policy/medical practice changes are 2 components: 1. Does it improve care, & 2. How much does it cost? Serious attention is finally being paid to medical ramifications of Social Determinants of Healthcare, racism, and resultant inequitable care. This study focuses on the second question: What are the short and long-term financial consequences (FC) of disparate care? Cesarean delivery rates (CDR) by race/ethnic group, have higher levels of morbidity and mortality and serve as a surrogate for quality of care. Using a GDP-based statistical dollar value metric of each life, we calculate long-term FC of disparate care. We compare representative states having generally perceived high and low spending on obstetrical care infrastructures and posed the following question: if CDR for Black patients were reduced to that of white patients, what FC would there be for short-term and long-term care. Long term costs are calculated as (additional hospital stay days X avg. cost per day) + (additional avg. recovery days X avg. daily GDP contribution). Most states show considerably higher CDR and morbidity/mortality for Black patients vs. white. Reducing Black CDR to white levels, short-term US savings would be $263M. Maternal and neonatal mortality rates (MMR and NMR) for Blacks are also higher [excess cost for Black MMR = $224M]. States with higher maternal and neonatal MR have significant impact on lifetime economic productivity. Nationally, the annual cost of excess MMR & NMR is $3.147 Billion from increased costs, reduced incomes, and tax revenues. In CA economic reductions are $471 per delivery; in GA it’s $1665. In addition to general societal deleterious effects of disparities, the perception of “saving” money by not spending for better care is wrong. Long term State FC show no short-term savings and increased long term expenses. Ignoring (momentarily) the commonly articulated quality of care reasons for fixing the provision of care, it costs the US $ 3.634 Billion per year that could be better allocated.
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.
The original goal of electronic fetal monitoring was to reduce stillbirths. It worked. Then the mission expanded to reducing neurologic impairment including cerebral palsy. Despite 50 years' experience, the data have been contradictory, and even the key opinion leaders of EFM admit it an only detect about half the problems. Concomitantly, the cesarean delivery rate which has greater complications and costs has increased about 6-fold. Here we review multiple generations of antenatal testing schemes having increasing sophistication but still not too much improvement in outcomes and our re-engineered approach to intrapartum fetal monitoring for which we morph from the subjective Category system which has poor statistical performance metrics to a new approach we call the "Fetal Reserve Index." The FRI breaks down the tracing into 4 quantifiable components (fetal heart rate, variability, accelerations, and decelerations) and then formally adds to the analysis the presence of increased uterine activity, and maternal, fetal, and obstetrical risk factors. In version 1.0, all parameters are weighted equally. We have shown improved and earlier identification of fetal risk earlier in the pathophysiology allowing less abrupt and dramatic interventions. We have further shown the early postpartum period to be one of commonly unrecognized risks, and we envision a continuum of assessment from antepartum through intrapartum and postpartum for optimal results.
ABSTRACTImportanceAmerican maternal and neonatal mortality rates are the worst of the world’s high-income countries. These rates are particularly low among patients of color, who have higher Cesarean delivery rates (CDR), higher healthcare costs, and poorer outcomes than White patients. However, common economic analyses do not address interlinked issues and therefore underestimate both the hidden causes of health inequities and the resultant costs to taxpayers. We have therefore designed a more comprehensive health economic model and metric (DEVELOP) that incorporates population health, equity, and economic integration.Design & MeasuresThe DEVELOP model, a childbirth-specific model of the societal economic gain or loss related to healthcare outcomes, incorporates an individual’s long-term economic contributions into its calculations of economic benefits. We first used our model to estimate fiscal outcomes if each state’s CDR for Black patients was lowered to that of White patients. Second, we calculated the costs of “excess” CDR and mortalities among Black patients. Third, we incorporated the additional long-term economic contributions of mothers and their children.ResultsIn the U.S., maternal and neonatal mortality rates and associated costs were higher for Black patients than White patients, and states with the lowest per capita health expenditures showed worse maternal outcomes and higher continuing costs. If the Black patient CDR were reduced to the White patient CDR, taxpayer-funded healthcare programs would save $263 million annually. Reducing the Black patient MMR would improve economic output by $224 million per year, and reducing the Black patient NMR would save $3.1 billion per year, for a combined economic improvement of $3.3 billion annually.Conclusions and RelevanceThe costs of improved prenatal care should be reconceptualized as investments for future economic growth rather than as short-term burdens. Policies blocking reasonable investments in health equity are counterproductive.
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.
OBJECTIVE: This systematic review and meta-analysis aimed to compare the fetal survival rate and perinatal outcomes of triplet pregnancies after selective reduction to twin pregnancies vs singleton pregnancies. DATA SOURCES: PubMed, Web of Science, Scopus, and Embase were systematically searched from the inception of the databases to January 16, 2022. STUDY ELIGIBILITY CRITERIA: Studies comparing the survival and perinatal outcomes between reduction to twin pregnancies and reduction to singleton pregnancies were included. The primary outcomes were fetal survival, defined as a live birth at >24 weeks of gestation. The secondary outcomes were gestational age at birth, preterm birth at <32 and <34 weeks of gestation, early pregnancy loss (<24 weeks of gestation), low birthweight, and rate of neonatal demise (up to 28 days after birth). METHODS: The random-effect model was used to pool the mean differences or odds ratios and the corresponding 95% confidence intervals. To provide a range of expected effects if a new study was conducted, 95% prediction intervals were calculated for outcomes presented in >3 studies. RESULTS: Of note, 10 studies with 2543 triplet pregnancies undergoing fetal reduction, of which 2035 reduced to twin pregnancies and 508 reduced to singleton pregnancies, met the inclusion criteria. Reduction to twin pregnancies had a lower rate of fetal survival (odds ratio, 0.61; 95% confidence interval, 0.40-0.92; P=.02; 95% prediction interval, 0.36-1.03) and comparable rates of early pregnancy loss (odds ratio, 0.89; 95% confidence interval, 0.58-1.38; P=.61; 95% prediction interval, 0.54-1.48) and neonatal demise (odds ratio, 0.57; 95% confidence interval, 0.09-3.50; P=.55) than reduction to singleton pregnancies. Reduction to twin pregnancies had a significantly lower gestation age at birth (weeks) (mean difference, -2.20; 95% confidence interval, -2.80 to -1.61; P<.001; 95% prediction interval, -4.27 to - 0.14) than reduction to singleton pregnancies. Furthermore, reduction to twin pregnancies was associated with lower birthweight and greater risk of preterm birth at <32 and <34 weeks of gestation. CONCLUSION: Triplet pregnancies reduced to twin pregnancies had a lower fetal survival rate of all remaining fetuses, lower gestational age at birth, higher risk of preterm birth, and lower birthweight than triplet pregnancies reduced to singleton pregnancies; reduction to twin pregnancies vs reduction to singleton pregnancies showed no substantial difference for the rates of early pregnancy loss and neonatal death.
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.
Fetal and neonatal monitoring are used in the vast majority of labors in high income countries and less in many low and middle income countries. The purpose is to identify compromise during the birth process, related mostly to hypoxemia, which if not quickly remediated can cause neurodevelopmental abnormalities. Monitoring can be continuous or intermittent, biochemical or biophysical, focused on a wide range of physiological parameters, or limited. There have been various protocols promoted over the past 50+ years which have strengths and weaknesses - both technical and interpretive. We have shown that continued monitoring postpartum should be an integral component. Our goal here is to improve the quality of neonatal monitoring to make it widely available, inexpensive, and to have sufficient statistical performance to change and improve clinical management both before and after delivery. Here, we describe preliminary results comparing several modes of carbon dioxide and pH sensing towards integration of these sensors against standard sensors for temperature, oxygen, and heart rate.
Abstract 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.
Medical College of Georgia at Augusta University, Augusta, Georgia Fetal Medicine Foundation of America, New York, New York Icahn School of Medicine at Mt. Sinai and Fetal Medicine Foundation of America, New York, New York Financial Disclosure Dr. Evans has patents and publication on the Fetal Reserve Index, which is mentioned in the Letter. The other authors did not report any potential conflicts of interest. Editor's Note:Johnson et al declined to respond.
A false negative can happen in many kinds of medical tests, regardless of whether they are screening or diagnostic in nature. However, it inevitably poses serious concerns especially in a prenatal setting because its sequelae can mark the birth of an affected child beyond expectation. False negatives are not a new thing because of emerging new tests in the field of reproductive, especially prenatal, genetics but has occurred throughout the evolution of prenatal screening and diagnosis programs. In this paper we aim to discuss the basic differences between screening and diagnosis, the trade-offs and the choices, and also shed light on the crucial points clinicians need to know and be aware of so that a quality service can be provided in a coherent and sensible way to patients so that vital issues related to a false negative result can be appropriately comprehended by all parties.
Advanced maternal age was the be all and end all of prenatal risk assessment for aneuploidy for nearly half a century. In virtually all countries, women a given age cutoff were regarded as being at high enough risk of aneuploidy to warrant the costs, hazards of performing an invasive, diagnostic procedure. Since alpha-fetoprotein (AFP) was already widely being used to screen for neural tube defects, at 16 to 18 weeks of gestation, it was relatively simple to include aneuploidy. Maternal serum AFP screening for aneuploidy was widely adopted, had the potential to increase the detection rate, but it was inefficient. While the diagnosis of Mendelian disorders may be possible by fetal cells or cell-free DNA, it is very likely that aneuploidy detection will be seen as a screening test to modify risk as a predicate for invasive diagnostic procedures. Considerable work in the mid-1990s focused on the development of ultrasound markers to be used to modify the risk of aneuploidy.
There has been a geometric explosion in genetic capabilities such that currently a wide variety of prenatal screening and diagnostic testing for fetal chromosomal abnormalities are available. Ideally, all woman should be counseled in each pregnancy about the benefits and limitations of available testing (American College of Obstetricians and Gynecologists, 2020). In countries where equity and budgets are prioritized over personal choice by the various National Health Services, testing is offered only when a specific risk cut-off is reached. In the present issue, Antoni Borrell enlightens us on the impact of health education on informed decision. A randomized controlled trial was conducted on 160 pregnant women undergoing first trimester aneuploidy screening (Miño et al., https://doi.org/10.3389/fgene.2020.561283). After receiving an extensive counseling, more women opted for an invasive prenatal testing while less women opted for the first trimester combined test and cell free DNA testing, as compared to those without extensive counseling (Miño et al., https://doi.org/10.3389/fgene.2020.561283).Recently, American College of Medical Genetics and Genomics (ACMG) recommends a consistent and equitable approach for offering carrier screening to all women during pregnancy or before This is a provisional file, not the final typeset article conception (Gregg et al., 2021
Nakao et al1Nakao M. Okumura A. Hasegawa J. et al.Fetal heart rate pattern in term or near-term cerebral palsy: a nationwide cohort study.Am J Obstet Gynecol. 2020; 223: 907.e1-907.e13Abstract Full Text Full Text PDF Scopus (5) Google Scholar rigorously categorized electronic fetal monitoring (EFM) for 1069 cases of severe cerebral palsy (CP). However, our interpretation of their data is somewhat different than the authors. They concluded that, on admission, approximately 30% of cases were already damaged. Accurately identifying such cases would suggest that better strategies for antepartum assessment and action are needed. Some cases of CP certainly have genetic origin and are not preventable, but other cases of CP might have benefited from earlier intervention. We believe that using our multipublished metric, the Fetal Reserve Index (FRI), those cases would likely on admission have been scored as red zone, implying that the fetuses were already in trouble. We consider EFM to be a classic screening test. As such, frequent unanalyzable cases constitute poor screening test metrics. Consequently, more than 20% of their cases were “unclassified” and not included. In addition, they concluded that another 20% of their cases were of postpartum origin. Focusing only on the R-Hon pattern, the authors concluded that only 16% of cases were preventable, which artificially dilutes the importance of labor management. Such method perceptually minimizes the need for adequate evaluation, management, and personnel being available. By removing the damaged cases and 10% of unclassified cases (hypothesizing half of unclassified cases might be identified with a better system), many more cases could actually be amenable to risk reduction with precision evaluation. We have taken an expansive approach to EFM interpretation. With EFM evaluation contextualized by uterine activity and maternal, fetal, and obstetrical risk factors (FRI), our data suggested that screening metrics can be improved.2Evans M.I. Eden R.D. Britt D.W. Evans S.M. Schifrin B.S. Re-conceptualizing fetal monitoring.Eur J Gynecol Obstet. 2019; 1: 10-17Google Scholar, 3Evans M.I. Britt D.W. Eden R.D. Evans S.M. Schifrin B.S. Earlier and improved screening for impending fetal compromise.J Matern Fetal Neonatal Med. 2020; ([Epub ahead of print])Crossref Scopus (5) Google Scholar, 4Eden R.D. Evans M.I. Britt D.W. Evans S.M. Gallagher P. Schifrin B.S. Combined prenatal and postnatal prediction of early neonatal compromise risk.J Matern Fetal Neonatal Med. 2019; ([Epub ahead of print])Crossref Scopus (6) Google Scholar In addition, the 20% of cases that Nakoa categorized as having “postpartum” etiologies were consistent with our published observations that fetal and neonatal acid base balances (pH and base excess) typically worsen after birth before they get better, and 85% of neonates have a transient, significant tachycardia (both often beyond risk threshold levels).4Eden R.D. Evans M.I. Britt D.W. Evans S.M. Gallagher P. Schifrin B.S. Combined prenatal and postnatal prediction of early neonatal compromise risk.J Matern Fetal Neonatal Med. 2019; ([Epub ahead of print])Crossref Scopus (6) Google Scholar The last FRI score before birth accurately predicted high-risk neonatal cases, which forces us to question the authors’ conclusions that the etiology of such postpartum cases was beyond the scope of labor management. We believe that the research data of Nakao et al1Nakao M. Okumura A. Hasegawa J. et al.Fetal heart rate pattern in term or near-term cerebral palsy: a nationwide cohort study.Am J Obstet Gynecol. 2020; 223: 907.e1-907.e13Abstract Full Text Full Text PDF Scopus (5) Google Scholar are an important contribution, but we suggest that for patients who come into labor, without evidence of existing damage, most CP cases are at least potentially within the control of healthcare providers to maximize the likelihood of good outcomes. What happens after patients arrive and before mothers and babies leave are critical issues amenable to provider influence. Fetal heart rate pattern in term or near-term cerebral palsy: a nationwide cohort studyAmerican Journal of Obstetrics & GynecologyVol. 223Issue 6PreviewIt is crucial to interpret fetal heart rate patterns with a focus on the pattern evolution during labor to estimate the relationship between cerebral palsy and delivery. However, nationwide data are not available. Full-Text PDF Categorization of cerebral palsy cases: a different perspectiveAmerican Journal of Obstetrics & GynecologyVol. 225Issue 2PreviewWe thank Drs Evans and Britt for their Letter to the Editors1 regarding our original paper in the American Journal of Obstetrics & Gynecology.2 Full-Text PDF