Fetal and Neonatal Heart Rate Monitor for Developing Countries

2018

In most developing countries, although the vast majority of the people are living in the rural areas, the qualified medical doctors are not available there. Health care workers and paramedics, called village doctors, informal healthcare providers, are largely responsible for the rural medical care. Mishaps due to wrong diagnosis and inappropriate medication have been causing serious suffering that is preventable. While innovators have created many devices, the vast majority of these technologies do not find applications to address the needs and conditions in low-resource settings. The primary motive is to address the acute lack of affordable medical technologies for the poor people in low-resource settings. A low cost smart medical device that is portable, battery operated and can be used at any point of care has been developed to detect breathing rate, electrocardiogram (ECG) and arterial pulse rate to improve diagnosis and monitoring of patients and thus improve care and safety&lt...

BMJ Open

IntroductionContinuous physiological monitoring devices are often not available for monitoring high-risk neonates in low-resource settings. Easy-to-use, non-invasive, multiparameter, continuous physiological monitoring devices could be instrumental in providing appropriate care and improving outcomes for high-risk neonates in these low-resource settings.Methods and analysisThe purpose of this prospective, observational, facility-based evaluation is to provide evidence to establish whether two existing non-invasive, multiparameter, continuous physiological monitoring devices developed by device developers, EarlySense and Sibel, can accurately and reliably measure vital signs in neonates (when compared with verified reference devices). We will also assess the feasibility, usability and acceptability of these devices for use in neonates in low-resource settings in Africa. Up to 500 neonates are enrolled in two phases: (1) a verification and accuracy evaluation phase at Aga Khan Univers...

Reproductive health, 2018

Vital signs measurement can identify pregnant and postpartum women who require urgent treatment or referral. In low-resource settings, healthcare workers have limited access to accurate vital signs measuring devices suitable for their environment and training. The CRADLE Vital Signs Alert (VSA) is a novel device measuring blood pressure and pulse that is accurate in pregnancy and designed for low-resource settings. Its traffic light early warning system alerts healthcare workers to the need for escalation of care for women with hypertension, haemorrhage or sepsis. This study evaluated the usability and acceptability of the CRADLE VSA device. Evaluation was conducted in community and primary care settings in India, Mozambique and Nigeria and tertiary hospitals in South Africa. Purposeful sampling was used to convene 155 interviews and six focus groups with healthcare workers using the device (n = 205) and pregnant women and their family members (n = 41). Interviews and focus groups w...

Archives of Disease in Childhood, 2021

BackgroundGlobally, 2.5 million neonates died in 2018, accounting for 46% of under-5 deaths. Multiparameter continuous physiological monitoring (MCPM) of neonates allows for early detection and treatment of life-threatening health problems. However, neonatal monitoring technology is largely unavailable in low-resource settings.MethodsIn four evaluation rounds, we prospectively compared the accuracy of the EarlySense under-mattress device to the Masimo Rad-97 pulse CO-oximeter with capnography reference device for heart rate (HR) and respiratory rate (RR) measurements in neonates in Kenya. EarlySense algorithm optimisations were made between evaluation rounds. In each evaluation round, we compared 200 randomly selected epochs of data using Bland-Altman plots and generated Clarke error grids with zones of 20% to aid in clinical interpretation.ResultsBetween 9 July 2019 and 8 January 2020, we collected 280 hours of MCPM data from 76 enrolled neonates. At the final evaluation round, the...

BMC pregnancy and childbirth, 2018

Neonatal mortality is a global challenge, with an estimated 1.3 million intrapartum stillbirths in 2015. The majority of these were found in low resource settings with limited options to intrapartum fetal heart monitoring devices. This trial compared frequency of abnormal fetal heart rate (FHR) detection and adverse perinatal outcomes (i.e. fresh stillbirths, 24-h neonatal deaths, admission to neonatal care unit) among women intermittently assessed by Doppler or fetoscope in a rural low-resource setting. This was an open-label randomized controlled trial conducted at Haydom Lutheran Hospital from March 2013 through August 2015. Inclusion criteria were; women in labor, singleton, cephalic presentation, normal FHR on admission (120-160 beats/minute), and cervical dilatation ≤7 cm. Verbal consent was obtained. A total of 2684 women were recruited, 1309 in the Doppler and 1375 in the fetoscope arms, respectively. Abnormal FHR was detected in 55 (4.2%) vs 42 (3.1%). (RR = 1.38; 95%CI: 0....

BMC Pregnancy and Childbirth, 2021

Background Women in sub-Saharan Africa have the highest rates of morbidity and mortality during childbirth globally. Despite increases in facility-based childbirth, gaps in quality of care at facilities have limited reductions in maternal deaths. Infrequent physiologic monitoring of women around childbirth is a major gap in care that leads to delays in life-saving interventions for women experiencing complications. Methods We will conduct a type-2 hybrid effectiveness-implementation study over 12 months to evaluate using a wireless physiologic monitoring system to detect and alert clinicians of abnormal vital signs in women for 24 h after undergoing emergency cesarean delivery at a tertiary care facility in Uganda. We will provide physiologic data (heart rate, respiratory rate, temperature and blood pressure) to clinicians via a smartphone-based application with alert notifications if monitored women develop predefined abnormalities in monitored physiologic signs. We will alternate ...

Scientific Reports

Multiparameter continuous physiological monitoring (MCPM) technologies are critical in the clinical management of high-risk neonates; yet, these technologies are frequently unavailable in many African healthcare facilities. We conducted a prospective clinical feasibility study of EarlySense’s novel under-mattress MCPM technology in neonates at Pumwani Maternity Hospital in Nairobi, Kenya. To assess feasibility, we compared the performance of EarlySense’s technology to Masimo’s Rad-97 pulse CO-oximeter with capnography technology for heart rate (HR) and respiratory rate (RR) measurements using up-time, clinical event detection performance, and accuracy. Between September 15 and December 15, 2020, we collected and analyzed 470 hours of EarlySense data from 109 enrolled neonates. EarlySense’s technology’s up-time per neonate was 2.9 (range 0.8, 5.3) hours for HR and 2.1 (range 0.9, 4.0) hours for RR. The difference compared to the reference was a median of 0.6 (range 0.1, 3.1) hours fo...

BMC Pregnancy and Childbirth

Background: Regular fetal heart rate monitoring during labor can drastically reduce fresh stillbirths and neonatal mortality through early detection and management of fetal distress. Fetal monitoring in low-resource settings is often inadequate. An electronic strap-on fetal heart rate monitor called Moyo was introduced in Tanzania to improve intrapartum fetal heart rate monitoring. There is limited knowledge about how skilled birth attendants in low-resource settings perceive using new technology in routine labor care. This study aimed to explore the attitude and perceptions of skilled birth attendants using Moyo in Dar es Salaam, Tanzania. Methods: A qualitative design was used to collect data. Five focus group discussions and 10 semi-structured indepth interviews were carried out. In total, 28 medical doctors and nurse/midwives participated in the study. The data was analyzed using qualitative content analysis. Results: The participants in the study perceived that the device was a useful tool that made it possible to monitor several laboring women at the same time and to react faster to fetal distress alerts. It was also perceived to improve the care provided to the laboring women. Prior to the introduction of Moyo, the participants described feeling overwhelmed by the high workload, an inability to adequately monitor each laboring woman, and a fear of being blamed for negative fetal outcomes. Challenges related to use of the device included a lack of adherence to routines for use, a lack of clarity about which laboring women should be monitored continuously with the device, and misidentification of maternal heart rate as fetal heart rate. Conclusion: The electronic strap-on fetal heart rate monitor, Moyo, was considered to make labor monitoring easier and to reduce stress. The study findings highlight the importance of ensuring that the device's functions, its limitations and its procedures for use are well understood by users.

International Journal of Environmental Research and Public Health

High-quality intrapartum care, including intermittent monitoring of fetal heart rates (FHR) to detect and manage abnormalities, is recommended by WHO and the Government of Tanzania (GoT) and creates potential to save newborn lives in Tanzania. Handheld Doppler devices have been investigated in several low-resource countries as an alternative to Pinard stethoscope and are more sensitive to detecting accelerations and decelerations of the fetal heart as compared to Pinard. This study assessed perspectives of high-level Tanzanian policymakers on facilitators and barriers to scaling up use of the hand-held Doppler for assessing FHR during labor and delivery. From November 2018–August 2019, nine high-level policymakers and subject matter experts were interviewed using a semi-structured questionnaire, with theoretical domains drawn from Proctor’s implementation outcomes framework. Interviewees largely saw use of Doppler to improve intrapartum FHR monitoring as aligning with national prior...

PUINOVAKESMAS, 2021

The prevalence of infant mortality rate in the world is still high, especially in Indonesia. One of the contributing factors to the high infant mortality rate is the delay in the early detection of fetal emergencies. Medical devices used in the health service at this time, can not be reached by all pregnant women independently. The fetal emergency early detection device is designed like a Doppler to listen to the fetal heart rate, but it is equipped with LED lights and alarms that will light up when the fetal heart rate indicates an emergency. This study will analyze the sensitivity, specificity, and acceptance rate of this fetal emergency detection device compared to Fetal Doppler as Gold Standard. This study is an experimental study, an experiment to determine the sensitivity and specificity of fetal emergency detection devices by comparing sensitivity and specificity with Fetal Doppler (Gold Standard) when used in pregnant women with >12 weeks pregnancy age. The results of thi...