Evaluation of the introduction of a novel device in the management of hypertension and shock in pregnancy in low-resource settings

Every day, approximately 800 women die in pregnancy or childbirth. 99% of all of these deaths occur in the developing world, with women in rural communities, with limited access to healthcare, at the greatest risk. The leading causes of death in these women include severe bleeding, overwhelming infections, and blood pressure problems. It is widely recognised that many women die in pregnancy because the problem is recognised too late. In all of these instances, simply monitoring women's blood pressure and pulse could be lifesaving. A woman would be recognised as being unwell and appropriately treated before serious, irreversible complications set in. In the developing world many healthcare providers do not have access to working blood pressure devices. Many devices that are available are often inaccurate in pregnancy, particularly in women with BP problems. This means that unwell women go unrecognised and treatment is either delayed or not given, which can result in serious illness and even death.

We have developed a simple, accurate, handheld device to measure blood pressure and pulse. This device has some special features that make it ideal for use in the developing world. It does not require medically training and anyone can use the device with minimal skill. This makes it ideal for use in communities, particularly rural settings, where untrained health workers commonly visit women and their babies. Another special feature is the 'traffic light' system; the device tells the user if the blood pressure and pulse measurements are normal (green), worrying (amber) or severely abnormal (red). This enables the device to signpost women who are unwell, or becoming unwell, to untrained observers. This will enable more appropriate and early referral to higher-level care. The device has been tested extensively and is shown to be accurate in pregnant women, even those with blood pressure problems. The device can be charged through a regular mobile phone charger, has a long power life and a large easy-to-read screen. The device is cheap at less than 20 euros.

Through our previous work in rural community settings in Africa, we know that there is a need for access to blood pressure devices; many clinics have no access to working, accurate machines. This project will improve access for women to have accurate measurements of their blood pressure and pulse (a fundamental part of care for women in pregnancy). Our project intends to put these simple devices into communities with the aim of improving detection of pulse and blood pressure problems. By highlighting those who are unwell, we hope use of the device will lead to more women receiving the best, most appropriate care and fewer women dying or becoming seriously unwell from these devastating diseases.

Hypothesis: Implementation of the CRADLE package, the Microlife CRADLE Vital Sign Alert (VSA) device, a novel semi-automated vital-sign device incorporating a traffic light early warning system, and simple education package, to healthcare providers (HCPs) at community and facility levels will reduce maternal mortality and morbidity in low-income country (LIC) populations.

Aim: To reduce a composite of (all-cause) maternal mortality or major morbidity by 25%.

Objective:

To determine whether the CRADLE package prevents adverse maternal outcomes of the three leading causes of maternal death worldwide (obstetric haemorrhage, sepsis and pre-eclampsia)

Study Design: A multicentre stepped wedge cluster randomised controlled trial of the CRADLE package to maternity care settings (comprising of secondary or tertiary health centre with multiple satellite primary care centres). Eight LIC trial areas (Zimbabwe, Zambia (x2 areas), Sierra Leone, Uganda (x2 areas), Haiti, Malawi, and Ethiopia) and one Indian area will take part in the RCT and, before the trial begins, randomly allocated the date from when they are given the intervention.7 Outcomes: Primary outcome: a composite of maternal mortality or major morbidity (one of maternal death, ICU admission, eclampsia, stroke, or hysterectomy with no double counting).

Exploitation of research results: Following trial completion, we plan to publish our findings in high impact peer-reviewed research journals, with open-access publication, as well as disseminating our findings through high profile international and national global health and women's health conferences (e.g. FIGO).

Pregnant and Postpartum Women
Postpartum haemorrhage (PPH), sepsis and hypertension account > 50% of maternal deaths worldwide, 99% of which occur in LMICs. Assessment of these conditions relies on measuring vital signs - pulse and BP. In LMICs, pre-eclampsia is frequently under-detected, due to poor availability/poorly functioning BP devices and inadequate training. Accurate BP measurement is vital for detecting and monitoring pre-eclampsia allowing for medical therapy and appropriate transfer for delivery and cure. Vital sign measurement is crucial to manage other life threatening maternal conditions including haemorrhage and sepsis. Given that PPH can kill rapidly, early recognition is essential. Even when devices do exist, the recognition of compromise is often detected too late for referral for appropriate-level care. This can significantly impact on maternal mortality and morbidity.

The Microlife CRADLE Vital Sign Alert (VSA) is an accurate, easy-to-use and cheap vital sign-measuring device, suitable for low-resource settings use, which will aid in assessment of all these life-threatening conditions. It has the potential to benefit pregnant and postpartum women in LMICs, by enabling more reliable assessment of their wellbeing. It can be used in a wide variety of environments, from the community to high-level facilities. A traffic-light early warning system (EWS) has been incorporated into the device to alert HCPs to abnormalities in vital signs, which will enable prompt referral. The benefits to the public are far reaching; to the mother's unborn/newborn child, as well as her existing children. As well as the benefit to women in LMICs, the device is also well suited for use in pregnancy in high-income countries, and for non-pregnant adults.

Healthcare Providers
The CRADLE device fulfils the World Health Organization (WHO) requirements for use in LMICs and has a micro-USB port, enabling charging through generic mobile phone chargers, increasingly ubiquitous in the African continent. Compared to the vast majority of automated devices, it is accurate in pregnancy. This device will be of benefit to all including community end-users (HCPs), as it is easy-to-use, accurate and the traffic-light EWS alerts HCPs to abnormalities in vital signs, suggesting need for intervention. Our CRADLE 1&2 work has highlighted the inadequate access to appropriate devices and the enthusiasm and need for better devices by HCPs. It is likely that the introduction of the CRADLE package, including basic training, will positively impact on the workload of HCPs. The device is more portable and easier to use than nearly all alternative BP devices used. It will provide increased autonomy of HCPs, giving improved decision-making tools (EWS).

Stakeholders and policy-makers
Although there has been a downturn in maternal deaths worldwide, this is far from the goals stated in the Millennium Development Goals, and that achieved in high-income countries. We are proposing to introduce the novel CRADLE device through all levels from community to tertiary level facilities. This will be of interest to local, national and potentially international health policy makers, as the intervention (and consequent action to reduce morbidity/mortality) is relatively cheap, easy to integrate into current health systems and sustainable. We anticipate a low regulatory hurdle and rapid progression to adoption.

The information gained from the trial will provide evidence for improved commercialisation of the device, ensuring positive economic impact, as well as widespread access to our innovation. The distribution of a low-cost, yet reliable and accurate device will promote economic competitiveness in the area of BP (and vital sign) measuring devices and will offer local business opportunities, with the potential to generate sustained local demand and investments and ensuring effective global distribution and sustainability.