Mobil Monitoring Doppler Ultrasound (MoMDUS) study: protocol for a prospective, observational study investigating the use of artificial intelligence and low-cost Doppler ultrasound for the automated quantification of hypertension, pre-eclampsia and fetal growth restriction in rural Guatemala.

INTRODUCTION: Undetected high-risk conditions in pregnancy are a leading cause of perinatal mortality in low-income and middle-income countries. A key contributor to adverse perinatal outcomes in these settings is limited access to high-quality screening and timely referral to care. Recently, a low-cost one-dimensional Doppler ultrasound (1-D DUS) device was developed that front-line workers in rural Guatemala used to collect quality maternal and fetal data. Further, we demonstrated with retrospective preliminary data that 1-D DUS signal could be processed using artificial intelligence and deep-learning algorithms to accurately estimate fetal gestational age, intrauterine growth and maternal blood pressure. This protocol describes a prospective observational pregnancy cohort study designed to prospectively evaluate these preliminary findings. METHODS AND ANALYSIS: This is a prospective observational cohort study conducted in rural Guatemala. In this study, we will follow pregnant women (N =700) recruited prior to 18 6/7 weeks gestation until their delivery and early postpartum period. During pregnancy, trained nurses will collect data on prenatal risk factors and obstetrical care. Every 4 weeks, the research team will collect maternal weight, blood pressure and 1-D DUS recordings of fetal heart tones. Additionally, we will conduct three serial obstetric ultrasounds to evaluate for fetal growth restriction (FGR), and one postpartum visit to record maternal blood pressure and neonatal weight and length. We will compare the test characteristics (receiver operator curves) of 1-D DUS algorithms developed by deep-learning methods to two-dimensional fetal ultrasound survey and published clinical pre-eclampsia risk prediction algorithms for predicting FGR and pre-eclampsia, respectively. ETHICS AND DISSEMINATION: Results of this study will be disseminated at scientific conferences and through peer-reviewed articles. Deidentified data sets will be made available through public repositories. The study has been approved by the institutional ethics committees of Maya Health Alliance and Emory University.

Critical appraisal of technologies to assess electrical activity during atrial fibrillation: a position paper from the European heart rhythm association and European society of cardiology working group on ecardiology in collaboration with the heart rhythm society, Asia pacific heart rhythm society, Latin American Heart rhythm society and computing in cardiology

Abstract We aim to provide a critical appraisal of basic concepts underlying signal recording and processing technologies applied for (I) atrial fibrillation (AF) mapping to unravel AF mechanisms and/or identifying target sites for AF therapy and (ii) AF detection, to optimize usage of technologies, stimulate research aimed at closing knowledge gaps, and developing ideal AF recording and processing technologies. Recording and processing techniques for assessment of electrical activity during AF essential for diagnosis and guiding ablative therapy including body surface electrocardiograms (ECG) and endo- or epicardial electrograms (EGM) are evaluated. Discussion of (I) differences in uni-, bi-, and multi-polar (omnipolar/Laplacian) recording modes, (ii) impact of recording technologies on EGM morphology, (iii) global or local mapping using various types of EGM involving signal processing techniques including isochronal-, voltage- fractionation-, dipole density-, and rotor mapping, enabling derivation of parameters like atrial rate, entropy, conduction velocity/direction, (iv) value of epicardial and optical mapping, (v) AF detection by cardiac implantable electronic devices containing various detection algorithms applicable to stored EGMs, (vi) contribution of machine learning (ML) to further improvement of signals processing technologies. Recording and processing of EGM (or ECG) are the cornerstones of (body surface) mapping of AF. Currently available AF recording and processing technologies are mainly restricted to specific applications or have technological limitations. Improvements in AF mapping by obtaining highest fidelity source signals (e. g. catheter­electrode combinations) for signal processing (e. g. filtering, digitization, and noise elimination) is of utmost importance. Novel acquisition instruments (multi-polar catheters combined with improved physical modelling and ML techniques) will enable enhanced and automated interpretation of EGM recordings in the near future.

Estimating birth weight from observed postnatal weights in a Guatemalan highland community.

OBJECTIVE: Low birth weight is one of the leading contributors to global perinatal deaths. Detecting this problem close to birth enables the initiation of early intervention, thus reducing the long-term impact on the fetus. However, in low-and middle-income countries, sometimes newborns are weighted days or months after birth, thus challenging the identification of low birth weight. This study aims to estimate birth weight from observed postnatal weights recorded in a Guatemalan highland community. APPROACH: With 918 newborns recorded in postpartum visits at a Guatemalan highland community, we fitted traditional infant weight models (Count's and Reeds models). The model that fitted the observed data best was selected based on typical newborn weight patterns reported in the medical literature and previous longitudinal studies. Then, estimated birth weights were determined using the weight gain percentage derived from the fitted weight curve. MAIN RESULTS: The best model for both genders was the Reeds2 model, with a mean square error of 0.30 kg2 and 0.23 kg2 for male and female newborns, respectively. The fitted weight curves exhibited similar behavior to those reported in the literature, with a maximum weight loss around three to five days after birth, and birth weight recovery, on average, by day ten. Moreover, the estimated birth weight was consistent with the 2015 Guatemalan National Survey, no having a statistically significant difference between the estimated birth weight and the reported survey birth weights (two-sided Wilcoxon rank-sum test; [Formula: see text]). SIGNIFICANCE: By estimating birth weight at an opportune time, several days after birth, it may be possible to identify low birth weight more accurately, thus providing timely treatment when is required.

A Proxy for Detecting IUGR Based on Gestational Age Estimation in a Guatemalan Rural Population.

In-utero progress of fetal development is normally assessed through manual measurements taken from ultrasound images, requiring relatively expensive equipment and well-trained personnel. Such monitoring is therefore unavailable in low- and middle-income countries (LMICs), where most of the perinatal mortality and morbidity exists. The work presented here attempts to identify a proxy for IUGR, which is a significant contributor to perinatal death in LMICs, by determining gestational age (GA) from data derived from simple-to-use, low-cost one-dimensional Doppler ultrasound (1D-DUS) and blood pressure devices. A total of 114 paired 1D-DUS recordings and maternal blood pressure recordings were selected, based on previously described signal quality measures. The average length of 1D-DUS recording was 10.43 ± 1.41 min. The min/median/max systolic and diastolic maternal blood pressures were 79/102/121 and 50.5/63.5/78.5 mmHg, respectively. GA was estimated using features derived from the 1D-DUS and maternal blood pressure using a support vector regression (SVR) approach and GA based on the last menstrual period as a reference target. A total of 50 trials of 5-fold cross-validation were performed for feature selection. The final SVR model was retrained on the training data and then tested on a held-out set comprising 28 normal weight and 25 low birth weight (LBW) newborns. The mean absolute GA error with respect to the last menstrual period was found to be 0.72 and 1.01 months for the normal and LBW newborns, respectively. The mean error in the GA estimate was shown to be negatively correlated with the birth weight. Thus, if the estimated GA is lower than the (remembered) GA calculated from last menstruation, then this could be interpreted as a potential sign of IUGR associated with LBW, and referral and intervention may be necessary. The assessment system may, therefore, have an immediate impact if coupled with suitable intervention, such as nutritional supplementation. However, a prospective clinical trial is required to show the efficacy of such a metric in the detection of IUGR and the impact of the intervention.

mHealth intervention to improve the continuum of maternal and perinatal care in rural Guatemala: a pragmatic, randomized controlled feasibility trial.

BACKGROUND/OBJECTIVE: Guatemala's indigenous Maya population has one of the highest perinatal and maternal mortality rates in Latin America. In this population most births are delivered at home by traditional birth attendants (TBAs), who have limited support and linkages to public hospitals. The goal of this study was to characterize the detection of maternal and perinatal complications and rates of facility-level referral by TBAs, and to evaluate the impact of a mHealth decision support system on these rates. METHODS: A pragmatic one-year feasibility trial of an mHealth decisions support system was conducted in rural Maya communities in collaboration with TBAs. TBAs were individually randomized in an unblinded fashion to either early-access or later-access to the mHealth system. TBAs in the early-access arm used the mHealth system throughout the study. TBAs in the later-access arm provided usual care until crossing over uni-directionally to the mHealth system at the study midpoint. The primary study outcome was the monthly rate of referral to facility-level care, adjusted for birth volume. RESULTS: Forty-four TBAs were randomized, 23 to the early-access arm and 21 to the later-access arm. Outcomes were analyzed for 799 pregnancies (early-access 425, later-access 374). Monthly referral rates to facility-level care were significantly higher among the early-access arm (median 33 referrals per 100 births, IQR 22-58) compared to the later-access arm (median 20 per 100, IQR 0-30) (p = 0.03). At the study midpoint, the later-access arm began using the mHealth platform and its referral rates increased (median 34 referrals per 100 births, IQR 5-50) with no significant difference from the early-access arm (p = 0.58). Rates of complications were similar in both arms, except for hypertensive disorders of pregnancy, which were significantly higher among TBAs in the early-access arm (RR 3.3, 95% CI 1.10-9.86). CONCLUSIONS: Referral rates were higher when TBAs had access to the mHealth platform. The introduction of mHealth supportive technologies for TBAs is feasible and can improve detection of complications and timely referral to facility-care within challenging healthcare delivery contexts. TRIAL REGISTRATION: Clinicaltrials.gov NCT02348840 .

Agile Development of a Smartphone App for Perinatal Monitoring in a Resource-Constrained Setting.

Technology provides the potential to empower frontline healthcare workers with low levels of training and literacy, particularly in low- and middle-income countries. An obvious platform for achieving this aim is the smartphone, a low cost, almost ubiquitous device with good supply chain infrastructure and a general cultural acceptance for its use. In particular, the smartphone offers the opportunity to provide augmented or procedural information through active audiovisual aids to illiterate or untrained users, as described in this article. In this article, the process of refinement and iterative design of a smartphone application prototype to support perinatal surveillance in rural Guatemala for indigenous Maya lay midwives with low levels of literacy and technology exposure is described. Following on from a pilot to investigate the feasibility of this system, a two-year project to develop a robust in-field system was initiated, culminating in a randomized controlled trial of the system, which is ongoing. The development required an agile approach, with the development team working both remotely and in country to identify and solve key technical and cultural issues in close collaboration with the midwife end-users. This article describes this process and intermediate results. The application prototype was refined in two phases, with expanding numbers of end-users. Some of the key weaknesses identified in the system during the development cycles were user error when inserting and assembling cables and interacting with the 1-D ultrasound-recording interface, as well as unexpectedly poor bandwidth for data uploads in the central healthcare facility. Safety nets for these issues were developed and the resultant system was well accepted and highly utilized by the end-users. To evaluate the effectiveness of the system after full field deployment, data quality, and corruption over time, as well as general usage of the system and the volume of application support for end-users required by the in-country team was analyzed. Through iterative review of data quality and consistent use of user feedback, the volume and percentage of high quality recordings was increased monthly. Final analysis of the impact of the system on obstetrical referral volume and maternal and neonatal clinical outcomes is pending conclusion of the ongoing clinical trial.

An mHealth monitoring system for traditional birth attendant-led antenatal risk assessment in rural Guatemala.

Limited funding for medical technology, low levels of education and poor infrastructure for delivering and maintaining technology severely limit medical decision support in low- and middle-income countries. Perinatal and maternal mortality is of particular concern with millions dying every year from potentially treatable conditions. Guatemala has one of the worst maternal mortality ratios, the highest incidence of intra-uterine growth restriction (IUGR), and one of the lowest gross national incomes per capita within Latin America. To address the lack of decision support in rural Guatemala, a smartphone-based system is proposed including peripheral sensors, such as a handheld Doppler for the identification of foetal compromise. Designed for use by illiterate birth attendants, the system uses pictograms, audio guidance, local and cloud processing, SMS alerts and voice calling. The initial prototype was evaluated on 22 women in highland Guatemala. Results were fed back into the refinement of the system, currently undergoing RCT evaluation.