Blood pressure after PREeclampsia/HELLP by SELF monitoring (BP-PRESELF): rationale and design of a multicenter randomized controlled trial.

BACKGROUND: Hypertensive disorders of pregnancy (HDP), such as preeclampsia (PE) or the Hemolysis Elevated Liver enzymes and Low Platelets (HELLP) syndrome are associated with elevated cardiovascular disease (CVD) risks, but standardized prevention guidelines after such pregnancies are lacking. Hypertension is the first emerging risk factor after PE/HELLP pregnancies and is a major risk factor for CVD. Hypertension before the age of 55 years may lead to various manifestations of end-organ damage at relatively young age. Therefore, timely treatment of elevated blood pressure is mandatory, but many of these high-risk women have long-term undetected and untreated hypertension before adequate treatment is initiated. AIM: The aim of our study is to assess whether home blood pressure monitoring (HBPM) in women with a previous PE/HELLP pregnancy is a valuable tool for the early detection of hypertension. METHODS: Women with a history of both early and late PE/HELLP syndrome aged 40-60 years are invited to participate. Patients with a history of CVD, known hypertension and/or use of antihypertensive medication are excluded. Women are randomized between HPBM or 'usual care'. The primary outcome is feasibility and usability of HBPM after 1 year of follow-up. Secondary outcomes will be the effectiveness of HPBM to detect hypertension, the efficacy of BP treatment, quality of life, health-related symptoms, work ability, and life-style behaviour. The results of this study will provide better strategies for timely detection and prevention of hypertension in women after PE/HELLP. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03228082. Registered June 15, 2017.

Home blood pressure monitoring detects unrevealed hypertension in women with a history of preeclampsia: Results of the BP-PRESELF study.

Objectives: The risk of cardiovascular disease more than doubles after hypertensive disorders of pregnancy. As early onset chronic hypertension contributes to cardiovascular risk, implementation of screening strategies, using home blood pressure monitoring (HBPM), may help to improve long-term cardiovascular health.We evaluated whether HBPM among women with a history of preeclampsia/HELLP syndrome is feasible for early detection and management of hypertension. Methods: The BP-PRESELF study is a multicenter randomized controlled trial. Participants were randomized to intervention group with HBPM for the duration of 1 year or the control group with 'usual care'. The primary outcome was feasibility of HBPM during 1 year of follow-up, defined as protocol adherence, protocol persistence and patient acceptance. Secondary outcomes were blood pressure levels and prevalence of hypertension. Results: We recruited 198 women with a mean age of 45 years. Protocol adherence decreased during the first 6 months, after which it stabilized. Protocol persistence remained high throughout follow-up. During the study period, 33 women (34%) in the intervention group were diagnosed with hypertension versus only 10 women (11%) in the control group, P<0.001. At 1-year follow-up, mean systolic blood pressure (SD) was 120.4 (11.6) mmHg in the intervention group versus 126.1 (14.3) mmHg in the control group, P=0.003. Mean diastolic blood pressure (SD) values were 77.1 (8.0) mmHg versus 81.7 (9.4) mmHg, P<0.001, respectively. Adjusted systolic and diastolic differences (95% confidence interval) were -6.81 (-10.17, -3.45) and -4.93 (-7.26, -2.61) mm Hg, with 80% less hypertension at 1-year follow-up in the intervention group. Conclusions: HBPM appears to be feasible for follow-up of blood pressure in women after preeclampsia/HELLP syndrome, while it detected hypertension and blood pressure levels reduced in one-third of women in this group.