Blood Pressure After PREeclampsia/HELLP by SELF Monitoring Study

Summary

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.

Conditions

• Preeclampsia
• Cardiovascular Risk Factor
• Cardiovascular Diseases
• Hypertension

Interventions

DEVICE

Home Blood Pressure Monitoring (HBPM)

Home blood pressure monitoring using the Withings Wireless BP monitor. Patients will be asked to measure their blood pressure twice daily for 7 consecutive days. This will be repeated for every month for 1 year.

Sponsors & Collaborators

• Interreg

  collaborator OTHER

• Radboud University Medical Center

  lead OTHER

Principal Investigators

• A.H.E.M. Maas, Prof.dr. · Radboudumc, department Cardiology

Study Design

Allocation

RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

60 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-07-13

Primary Completion

2019-12-30

Completion

2019-12-30

Countries

• Germany
• Netherlands

Study Locations