Title: Optimising the monitoring and management of raised blood pressure during and after pregnancy
Funder: Department of Health and Social Care

Abstract: Aims, Objectives and Research Questions The overall aim of this programme of work is to evaluated whether self-monitoring of BP can improve the detection of raised BP during pregnancy, whether it is feasible for use in the titration of antihypertensive medication in pregnancy hypertension and whether women with raised BP in pregnancy can accurately test their urine for proteinuria. Linked qualitative and economic components assess patient and professional experiences of self-monitoring and responses to it along with cost effectiveness within the trial and in the longer term. The key research questions are: WS1: Development What are the best self-monitoring interventions to use? How can self-monitoring of BP and urine best integrate into current antenatal care pathways? WS2: Self-monitoring to detect raised BP in pregnancy What is current practice in BP self-monitoring in pregnancy? Can BP self-monitoring improve the detection of BP during pregnancy? How is BP self-monitoring in pregnancy implemented in daily life and routine clinical practice? Is BP self-monitoring in pregnancy cost-effective? WS3: BP self-monitoring during and after pregnancy for detection of hypertension and antihypertensives titration Is titration of antihypertensive medication during and after pregnancy using self-monitoring feasible? What is the participant and professional experience of such monitoring and titration? WS4: Self-monitoring of urinary protein in hypertensive pregnancy Can pregnant women with hypertension accurately self-monitor for proteinuria and could this detect pre-eclampsia earlier than usual care? Is self-monitoring of urine practical and acceptable to hypertensive pregnant women, their midwives and obstetricians? WS5: Modelling of the potential long term costs and consequences Is self-monitoring of blood pressure and protein in hypertensive pregnancy potentially cost-effective and what are the key parameters affecting this? Background and rationale Raised BP affects 10% of pregnancies worldwide of which around half develop pre-eclampsia &ndash; hypertension plus proteinuria - a leading cause of maternal and perinatal morbidity and mortality. Early detection and subsequent management of pregnancy hypertension is therefore important and could be improved through self-monitoring whilst empowering women and allowing reduced antenatal visits. Our systematic review has shown that little evidence is currently available to guide the utilisation of self-monitoring. Feasibility work by ourselves in Oxford and Birmingham including 201 women has shown that self-monitoring of BP and urine in pregnancy has potential and is well tolerated by women. The proposed programme is organised in five work streams (WS). Research plan WS1 will fine tune our already developed interventions, finalise them with our patient participant groups and through focus groups with professionals and ensure that they can be integrated into usual care. WS2 will test self-monitoring of hypertension in women at higher risk of hypertension in pregnancy as a screening tool. 2268 women will be individually randomised to either usual care or self-monitoring at 20 weeks gestation and followed up until delivery. The primary outcome will be time to first detection of raised clinic BP. Process evaluation will assess both quantitative (intervention fidelity for women and the professionals) and qualitative (patient and professional experiences of self-monitoring including ethnographic observation) aspects. Economic analyses will assess cost effectiveness. WS3 will evaluate the feasibility of using self-monitoring of BP to guide the titration of antihypertensive treatment both during and immediately after pregnancy. 160 pregnant women (80 with gestational hypertension and 80 with chronic hypertension) will be randomised to either self-monitoring of BP or usual care and followed up until six weeks postpartum. Linked process evaluation will assess both quantitative and qualitative outcomes. WS4 comprises a diagnostic test accuracy study with linked feasibility work testing the ability of pregnant women with raised BP to detect proteinuria in comparison to both midwives and a laboratory reference standard. Thrice weekly testing will assess whether a trial of self-testing might detect the development of pre-eclampsia earlier than usual care. Linked process evaluation will assess both quantitative and qualitative outcomes. WS5 will combine data from WS3 and 4 along with the prognostic literature and published costs into a mathematical model which will estimate long term cost-effectiveness along with the key parameters affecting this. Projected outputs & dissemination plans We have a strong track record of high impact publications which have been quickly adopted into national guidance and will ensure that the key outputs from this work receive wide exposure. Dissemination and implementation of our work will comprise a strategy of multiple outcomes: a) Scientific dissemination. b) Dissemination via professional societies. c) Implementation via National Guidelines. d) Dissemination via patient groups including Action on Pre-eclampsia. e) Dissemination via a multi media strategy. Benefits to patients and the NHS. Should self-monitoring of BP and urinary protein prove to be effective and cost-effective, then there will be the potential for substantial benefit for patients and the NHS, in terms of health gains, reduction in patient burden and reduced costs for both the health service and individuals.

Lay abstract: Background Raised blood pressure is a common problem in pregnancy. Pre-eclampsia is diagnosed if the mother has raised blood pressure and protein in her urine after the 20th week of pregnancy. Women with pre-eclampsia are at risk of developing problems with their kidneys, liver and blood clotting. They are also at risk of developing eclampsia &ndash; a serious condition with seizures - and their babies can be small or occasionally die before birth. Raised blood pressure and pre-eclampsia affect about one in ten women and are a major cause of death and premature birth. There is no test currently to predict who will get pre-eclampsia; diagnosis is made from monitoring blood pressure and urine at antenatal visits throughout the pregnancy. Early diagnosis of pre-eclampsia can reduce complications for both the mother and the baby. Antenatal visits take place approximately every four weeks in first pregnancies. Many women have expressed an interest in monitoring their own blood pressure in between these visits but there has been very little research to guide this. We would like to know if we could improve the diagnosis of raised blood pressure if women were able to monitor their own blood pressure and urine safely at home. We have conducted a study of 201 pregnant women who monitored their own blood pressure, of which 30 additionally monitored their urine. This research suggests, that with support from midwives and doctors, it is possible for women to monitor blood pressure and urine safely, potentially identifying problems earlier and controlling blood pressure better. Key Aims We will work with pregnant women, doctors and midwives to: Develop a simple and accurate method of self-monitoring blood pressure and urine in pregnancy. To compare self-monitoring with current care and to assess if self-monitoring can identify raised blood pressure earlier and so lower blood pressure. To see if self-monitoring helps doctors to decide the dose of blood pressure medication when looking after women who already have high blood pressure without pre-eclampsia. To assess if self-monitoring is cost effective. Expertise This work brings together leading experts in blood pressure, home monitoring, medicine in pregnancy, pre-eclampsia diagnosis, midwifery, safety, quality, clinical trials, statistics, sociology of health, anthropology and economics with a supportive group of women. Costs: We are asking for funding to cover the staff time and equipment needed to complete this work. NHS costs are required to cover the time of health professionals helping with the study. Ethical considerations This study involves pregnant women and their welfare is paramount. All study procedures will be over and above usual care. We will ensure that participating women receive care at least as good as usual and that data collection respects womens' privacy and dignity.

Research activity codes: 4.2 EVALUATION OF MARKERS AND TECHNOLOGIES;4.1 DISCOVERY AND PRECLINICAL TESTING OF MARKERS AND TECHNOLOGIES
Health categories: CARDIOVASCULAR;REPRODUCTIVE HEALTH AND CHILDBIRTH