Development and evaluation of a novel Vital Signs Alert device for use in pregnancy in low-resource settings
Open accessAbstract
OBJECTIVES: Haemorrhage, hypertension, sepsis and abortion complications (often from haemorrhage or sepsis) contribute to 60% of all maternal deaths. Each is associated with vital signs (blood pressure (BP) and pulse) abnormalities, and the majority of deaths are preventable through simple and timely intervention. This paper presents the development and evaluation of the CRADLE Vital Signs Alert (VSA), an accurate, low-cost and easy-to-use device measuring BP and pulse with an integrated traffic light early warning system. The VSA was designed to be used by all cadres of healthcare providers for pregnant women in low-resource settings with the aim to prevent avoidable maternal mortality and morbidity. METHODS: The development and the mixed-methods clinical evaluation of the VSA are described. RESULTS: Preliminary fieldwork identified that introduction of BP devices to rural clinics improved antenatal surveillance of BP in pregnant women. The aesthetics of the integrated traffic light system were developed through iterative qualitative evaluation. The traffic lights trigger according to evidence-based vital sign thresholds in hypertension and haemodynamic compromise from haemorrhage and sepsis. The VSA can be reliably used as an auscultatory device, as well as its primary semiautomated function, and is suitable as a self-monitor used by pregnant women. CONCLUSION: The VSA is an accurate device incorporating an evidence-based traffic light early warning system. It is designed to ensure suitability for healthcare providers with limited training and may improve care for women in pregnancy, childbirth and in the postnatal period.
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The CRADLE VSA device is a hand-held, semi-automated, low-cost blood pressure and heart rate measuring device with a built-in traffic-light warning system developed for use in low-income settings.
“The CRADLE Vital Sign Alert (VSA) device is a hand-held, semi-automated, low-cost BP and HR measuring device with a built-in traffic-light warning system that has been especially developed for use in low-income settings during pregnancy and the postpartum period [11].”
The CRADLE VSA device has undergone extensive testing for accuracy and is one of few blood pressure devices validated as accurate in pregnancy (including pre-eclampsia and hypotension) and in non-pregnant adults.
“The device has undergone extensive testing for accuracy and is one of few BP devices to have been validated as accurate in pregnancy (including pre-eclampsia and hypotension) and in non-pregnant adults [11, 23, 24].”
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- Authors
- Nathan, H. L., Vousden, N., Lawley, E., de Greeff, A., Hezelgrave, N. L., Sloan, N., Tanna, N., Goudar, S. S., Gidiri, M. F., Sandall, J., Chappell, L. C., & Shennan, A. H.
- Affiliations
- King's College London (GB)
- Validate Global, Kimberley, South Africa
- Jawaharlal Nehru Medical College (IN)
- University of Zimbabwe (ZW)
- Corresponding author
- Nathan, Hannah L
- ORCID
- Venue
- BMJ Innovations
- Publisher
- BMJ
- Published
- 2018-09-19
- Volume
- 4
- Issue
- 4
- Pages
- 192-198
- ISSN
- 2055-642X (ISSN-L)
- 2055-8074
- PMC
- PMC6173817
- OpenAlex
- W2889814070
- Cited by
- 31
- References
- 35
- Citations by year
- 2026: 1 · 2025: 4 · 2024: 2 · 2023: 8 · 2022: 1 · 2021: 7 · 2020: 3 · 2019: 4 · 2018: 1
- FWCI
- 1.50
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- cc-by
- Locations
- BMJ Innovations (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, other-oa)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Research Portal (King's College London) (submittedVersion, cc-by)
- UTS ePRESS (University of Technology Sydney) (submittedVersion)
- Greater South Information System
- Funders
- Bill and Melinda Gates Foundation (OPP1086183)
- National Institute for Health and Care Research (NF-SI-0514-10145, DRF-2013-06-171, ACF-2013-17-017, RP-2014-05-019)
- Medical Research Council (MR/N006240/1)
- Topics
- Physical Sciences › Engineering › Biomedical Engineering › Non-Invasive Vital Sign Monitoring
- Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Global Maternal and Child Health
- Keywords
- blood pressure measurement, pulse measurement, pregnancy, maternal mortality, hypertension in pregnancy, hemorrhage, sepsis, abortion complications, low-cost medical device, resource-limited settings, antenatal surveillance, self-monitoring, maternal health
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