Extrait

Background and study aims Pre-eclampsia is a condition which affects pregnant women, and can put both mother and baby at risk. The warning signs of pre-eclampsia include high blood pressure and protein in the urine. Around 10-15% of women develop high blood pressure during pregnancy. If not treated, pre-eclampsia can lead to seizures, kidney and blood clotting problems in the mother. For babies, it can lead to low birth weight and an increased risk of dying before birth. Treatment is usually in the form of blood pressure lowering drugs. Around 5% of women have chronic hypertension (long-term high blood pressure) before they become pregnant. This puts them at a higher risk of developing pre-eclampsia than those without chronic high blood pressure. Because of this, their blood pressure needs to be closely monitored and managed via more frequent antenatal clinic visits. Despite more frequent monitoring however, women's blood pressure can rise between these visits, putting mother and baby at risk. One possible solution to this problem is for the women to keep track of their blood pressure at home (self-monitoring). This could help to identify rising blood pressure sooner, so that it can be brought to the attention of their care team. This could lead to earlier diagnosis and treatment to prevent complications developing. Care teams would be able to use the more frequent blood pressure readings to make better and timelier treatment decisions. For example, by raising or lowering blood pressure medication as needed. This could lead to improved health outcomes for mothers and their babies, and may prove to be a cost-effective way to improve their care. The aim of this study is to conduct a small study looking at whether it is acceptable to pregnant women with high blood pressure to monitor their blood pressure at home, and to work out whether it is feasible to conduct a larger scale study. Who can participate? Pregnant women with long-term high blood pressure. What does the study involve? Participants are randomly allocated to one of two groups. Those in the first group receive standard care alone, which involves attending antenatal clinic visits to have their blood pressure measured. Those in the second group also receive standard care as well as monitoring their blood pressure at home. The women are taught how to use a home blood pressure monitor and asked to measure it every day and record the results in a diary. They are also given advice about any action they should take if their blood pressure becomes too high or too low. Participants in both groups attend routine clinical visits at 20, 28, and 34 weeks pregnancy, and 6 weeks after they have had their baby. At these visits, blood pressure measurements are taken and questionnaires about quality of life and medication use are completed. Women who have been monitoring their blood pressure also provide their self-monitoring results at these visits. What are the possible benefits and risks of participating? There are no direct benefits to participants taking part in this study, although the study will provide information about how blood pressure self-monitoring could help improve the health of women with chronic high blood pressure in pregnancy. This could lead to fewer complications during pregnancy, protecting the health of both mother and baby. All women in the study will receive at least usual care, so there is no risk from missing out on any standard clinical care. No direct risks for those women self-monitoring blood pressure at home are expected as measuring blood pressure is a safe procedure. Women will be counselled how to correctly measure their blood pressure using the provided monitors and when and how to contact clinical teams if they have low or high blood pressure readings. It is possible that blood pressure self-monitoring may increase anxiety in participants but previous work by the study team in the pregnant population has found this to be very uncommon. Where is the study run from? 1. The Women's Centre, John Radcliffe Hospital (UK) 2. St Thomas' Hospital Maternity Services (UK) 3. New Cross Hospital Maternity Services (UK) When is the study starting and how long is it expected to run for? April 2015 to October 2018 Who is funding the study? National Institute for Health Research (UK) Who is the main contact? Dr Louise Pealing [email protected]

Critère d'inclusion

• Specialty: Reproductive health and childbirth, Primary sub-specialty: Reproductive health and childbirth (migration)

Liens

• ictrp
• isrctn