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Completed

NCT Number: NCT03228082

Blood Pressure After PREeclampsia/HELLP by SELF Monitoring Study

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.

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Key information

Age range

40 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Katholisches Karl-Leisner-Klinikum GmbH, Kleve, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • previous preeclampsia/HELLP syndrome, defined as diastolic BP≥90 mmHg with proteinuria ≥ 0.3gram/24 h, during one or more pregnancies, more than 1 year ago.
  • 'early' or 'late' PE/HELLP
  • age ≥40 and ≤ 60 years

Exclusion criteria

  • pregnant women or women wishing for future pregnancie(s)
  • inability to perform self BP measurements
  • not having a smartphone (Apple or Android)
  • already having regular hypertension control by GP or medical specialist
  • previous cardiovascular events, such as myocardial infarction , stroke, heart failure and symptomatic ischemic heart disease

Treatment and study plan

Home Blood Pressure Monitoring (HBPM)

Device

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.

Primary outcomes

  1. Feasibility of HBPM after a previous preeclampsia to evaluate the prevalence of hypertension.

    Time frame: 1 year

    To evaluate feasibility of blood pressure home monitoring to diagnose hypertension at 1 year follow-up, in high-risk women with a previous preeclampsia. Feasibility will be measured using questionnaires (Likert scales).

Secondary outcomes

  1. Blood pressure values

    Time frame: 1 year

    Mean BP values (mmHg) in both study groups at 1 year of follow-up

  2. Prevalence of hypertension

    Time frame: 1 year

    Prevalence of hypertension in both groups at 1 year of follow-up

  3. Effect HBPM

    Time frame: 1 year

    Effect of regular self measurements on blood pressure levels at home at 1 year follow-up

Other outcomes

  1. Quality of Life

    Time frame: 1 year

    QOL measures related to blood pressure by repeated validated questionnaires

  2. Occupational activity

    Time frame: 1 year

    Questionnaires on ability to work and work-related obstacles

  3. BP patterns

    Time frame: 1 year

    Patterns of BP levels and incidence of hypertension during follow-up

  4. Cardiac symptoms

    Time frame: 1 year

    Cardiac symptoms and blood-pressure related symptoms

  5. Costs

    Time frame: 1 year

    Cost-effectiveness of BP self-management versus regular office-based visits

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Interreg

Registry information

Official study title

Blood Pressure After PREeclampsia/HELLP by SELF Monitoring

Acronym: BP-PRESELF

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 24, 2017
Registry last updated
Oct 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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