Blood Pressure After PREeclampsia/HELLP by SELF Monitoring Study

Not Applicable

Completed

• Conditions: Hypertension; Cardiovascular Diseases; Preeclampsia; Cardiovascular Risk Factor
• Interventions: Device: Home Blood Pressure Monitoring (HBPM)

• Registration Number: NCT03228082
• Lead Sponsor: Radboud University Medical Center

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-06-15
• Study Start: 2017-07-13
• Study First Submitted QC: 2017-07-19
• Study First Posted: 2017-07-24
• Primary Completion: 2019-12-30
• Study Completion: 2019-12-30
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-05
• Last Update Posted: 2020-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home Blood Pressure Monitoring (HBPM)	Home Blood Pressure Monitoring (HBPM)	Home monitoring of blood pressure will be performed. Blood pressure measurements will be entered automatically through a smartphone application into a patient-controlled medical record ('Patients Know Best'). The data will be available to the study coordinator, who will provide patients within 1 week with feedback on the measurements. If necessary lifestyle advice will be given, in case of hypertension patients will be referred to their GP. Once monthly a questionnaire on well-being (SF-12) and symptoms will be completed. After 6 months and 1 year patients will also receive a questionnaire on feasibility and usability of the blood pressure device.

Primary Outcome Measures

Name	Time	Method
Feasibility of HBPM after a previous preeclampsia to evaluate the prevalence of hypertension.	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 Outcome Measures

Name	Time	Method
Prevalence of hypertension	1 year	Prevalence of hypertension in both groups at 1 year of follow-up
Blood pressure values	1 year	Mean BP values (mmHg) in both study groups at 1 year of follow-up
Effect HBPM	1 year	Effect of regular self measurements on blood pressure levels at home at 1 year follow-up

Trial Locations

Locations (6)

Krankenhaus Bethanien; 🇩🇪 Moers, Germany

Radboudumc; 🇳🇱 Nijmegen, Netherlands

St. Josef Krankenhaus GmbH; 🇩🇪 Moers, Germany

Katholisches Karl-Leisner-Klinikum GmbH; 🇩🇪 Kleve, Germany

Rijnstate Ziekenhuis; 🇳🇱 Arnhem, Netherlands

Canisius-Wilhelmina Ziekenhuis; 🇳🇱 Nijmegen, Netherlands