ArticleBMJ innovations2018
Development and evaluation of a novel Vital Signs Alert device for use in pregnancy in low-resource settings.
Article in BMJ innovations, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
16 citing papers in PubMed, 1 synthesis or guideline pooled it, 32 citations in OpenAlex.
- The Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomised trials in Mozambique, Pakistan, and India: an individual participant-level meta-analysis.Lancet (London, England) · 2020Pooled it
- Effect of the CRADLE vital signs alert device intervention on referrals for obstetric haemorrhage in low-middle income countries: a secondary analysis of a stepped- wedge cluster-randomised control trial.BMC pregnancy and childbirth · 2021Trial
- Exploring the effect of implementation and context on a stepped-wedge randomised controlled trial of a vital sign triage device in routine maternity care in low-resource settings.Implementation science : IS · 2019Trial
- Effect of a novel vital sign device on maternal mortality and morbidity in low-resource settings: a pragmatic, stepped-wedge, cluster-randomised controlled trial.The Lancet. Global health · 2019Trial
- Terminal Digit Preference and Threshold Avoidance in Digital Blood Pressure Measurements During Pregnancy: Secondary Analysis of Data From the CLIP and PRECISE Cohorts.JMIR mHealth and uHealth · 2026Article
- Evaluating shock index for prediction of adverse maternal outcomes related to postpartum haemorrhage and maternal sepsis in Sierra Leone: a prospective observational cohort study.EClinicalMedicine · 2025Article
- Measured and self-reported hypertension among women of reproductive age, Gambia, Kenya, Mozambique.Bulletin of the World Health Organization · 2025Observational
- A novel approach to expedite evidence to impact in pre-eclampsia: co-developed policy labs in Zambia and Sierra Leone.BMC global and public health · 2025Article
- A compound analysis of medical device clinical trials registered in Africa on clinicaltrials.gov.Trials · 2024Review
- Article
- A Mobile Clinical Decision Support System for High-Risk Pregnant Women in Rural India (SMARThealth Pregnancy): Pilot Cluster Randomized Controlled Trial.JMIR formative research · 2023Article
- Understanding challenges as they impact on hospital-level care for pre-eclampsia in rural Ethiopia: a qualitative study.BMJ open · 2023Article
- Scale-up of a novel vital signs alert device to improve maternity care in Sierra Leone: a mixed methods evaluation of adoption.Reproductive health · 2023Article
- Home blood pressure monitoring: methodology, clinical relevance and practical application: a 2021 position paper by the Working Group on Blood Pressure Monitoring and Cardiovascular Variability of the European Society of Hypertension.Journal of hypertension · 2021Article
- A literature review and best practice advice for second and third trimester risk stratification, monitoring, and management of pre-eclampsia: Compiled by the Pregnancy and Non-Communicable Diseases Committee of FIGO (the International Federation of Gynecology and Obstetrics).International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2021Review
- SMARThealth Pregnancy: Feasibility and Acceptability of a Complex Intervention for High-Risk Pregnant Women in Rural India: Protocol for a Pilot Cluster Randomised Controlled Trial.Frontiers in global women's health · 2021Article
Corrections and comments
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Authors and funding
12 authors at 3 institutions in 3 countries.
Funding
Abstract
objectivesHaemorrhage, 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.
methodsThe development and the mixed-methods clinical evaluation of the VSA are described.
resultsPreliminary 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.
conclusionThe 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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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.