Extract

Background and study aims Every day about 800 women die in pregnancy or childbirth, and 99% of all of these deaths occur in the developing world. Women in rural communities with limited access to healthcare are at the greatest risk. The leading causes of death in these women include severe bleeding, overwhelming infections, and blood pressure problems. 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 life-saving. 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 blood pressure 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 medical 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 has been 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 £12. Through our previous work in rural community settings in Africa, we know that there is a need for access to blood pressure devices, as many clinics have no access to working, accurate machines. This study 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 study 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. Who can participate? Women who are pregnant or gave birth within the last 6 weeks, and living in the study catchment areas within the study time frame. What does the study involve? Pregnant women should have their blood pressure checked as part of routine antenatal care. This study involves replacing the current methods to measure blood pressure with the CRADLE VSA device, which is incorporated into routine care. There are no other changes to the patient’s care as part of the study. Healthcare practitioners may be asked to complete multiple-choice questionnaires or complete a log of their use of their device to assess the training materials. A sample of healthcare practitioners are also interviewed. A focus group discussion is undertaken at each site at three months. What are the possible benefits and risks of participating? By participating in this study, healthcare practitioners will get the chance to gain experience in using the blood pressure device and have improved access to accurate reliable equipment. Feedback provided by healthcare practitioners will help to improve the training and plan a larger study of this device in vulnerable women in pregnancy. The Microlife CRADLE VSA is used worldwide in pregnancy as a standard automated blood pressure device. We do not anticipate any risks to those using the devices or the participating women. A potential risk is that triggering of the traffic light early warning system may lead to more women being referred to a higher-level facility, thereby overwhelming the facility. Alternatively, the early warning system may give a false sense of stability of women, resulting in delay in referral. It is for this reason that the CRADLE package of care will include education about appropriate transport to facility, as well as instructions about how to manage women who do not trigger the early warning system but who are otherwise unwell. Where is the study run from? Morgenster Mission Hospital (Zimbabwe), Lusaka University Teaching Hospital (Zambia), Mulago Hospital, (Uganda), Haiti Hospital (Haiti), Tikur Anbessa University Hospital (Ethiopia), Zomba Hospital (Malawi), Ndola Central Hospital (Zambia), Princess Christian Maternity Hospital (Sierra Leone), Jawaharlal Nehru Medical College (India), Gimbie Adventist Hospital (Ethiopia), Mbale Regional Referral Hospital (Uganda), University of Zimbabwe (Zimbabwe). When is the study starting and how long is it expected to run for? October 2015 to March 2018 Who is funding the study? Medical Research Council (UK), Department Of Biotechnology (India), Department for International Development (UK). Who is the main contact? Prof Andrew Shennan [email protected]

Inclusion criteria

• Maternal mortality and major morbidity from the three leading causes of maternal death worldwide: obstetric haemorrhage, sepsis and pre-eclampsia

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