Hypertension Clinical Trial
Official title:
Blood Pressure After PREeclampsia/HELLP by SELF Monitoring
RATIONALE:
Women with a previous history of preeclampsia (PE)/HELLP have a twofold higher risk of
cardiovascular disease (CVD) and a fourfold increased risk to develop hypertension at a
relative young age. In the latest 2016 ESC guidelines 'CVD prevention', previous PE has been
acknowledged as a serious CVD risk factor in women. In clinical practice, however, these
women are still underappreciated for their CVD risk. It has not been established yet how
adequate lifelong prevention in these potentially high risk women can optimally be achieved
from their childbearing years onwards.
OBJECTIVE:
To evaluate feasibility, usability, acceptance and potential obstacles of blood pressure (BP)
home monitoring in high-risk women, aged 40-60 years, after a previous PE in pregnancy. In
addition to evaluate the effectiveness of BP home monitoring on the occurrence of
hypertension, the efficacy of BP treatment, quality of life (QOL), health-related symptoms,
work ability and life-style behaviour.
STUDY DESIGN:
Randomized, open label feasibility study to compare eHealth guided self management of BP
monitoring and lifestyle advice with 'usual care'.
STUDY POPULATION:
Approximately 200 women, aged ≥ 40 and ≤ 60 years, with a previous PE in pregnancy will be
invited to participate (both early and late PE). Patients will be recruited from the
departments of obstetrics/gynaecology in 6 centres in the Euregio Rhein-Waal and from the
department of cardiology Radboudumc.
INTERVENTION:
eHealth guided measurements of BP at regular intervals and recurrent lifestyle advice
(intervention-group) will be compared with "usual care".
PRIMARY OUTCOME:
Feasibility, usability, acceptance and potential obstacles of BP home monitoring in high-risk
women after a previous PE in pregnancy at 1 year of follow-up.
n/a
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