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Blood Pressure After PREeclampsia/HELLP by SELF Monitoring Study (BP-PRESELF)

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ClinicalTrials.gov Identifier: NCT03228082
Recruitment Status : Recruiting
First Posted : July 24, 2017
Last Update Posted : July 24, 2017
Information provided by (Responsible Party):
Radboud University

Brief Summary:


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.


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.


Randomized, open label feasibility study to compare eHealth guided self management of BP monitoring and lifestyle advice with 'usual care'.


Approximately 300 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.


eHealth guided measurements of BP at regular intervals and recurrent lifestyle advice (intervention-group) will be compared with "usual care".


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.

Condition or disease Intervention/treatment
Preeclampsia Cardiovascular Risk Factor Cardiovascular Diseases Hypertension Device: Home Blood Pressure Monitoring (HBPM)

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized at the end of the baseline visit to self-measurement of bloodpressure at home (intervention group) or usual care (control group).
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Blood Pressure After PREeclampsia/HELLP by SELF Monitoring
Actual Study Start Date : July 13, 2017
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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.

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.
No Intervention: Control group
Patients in the control group will be asked to register their blood pressure if measured during a doctor's visit, and to note medication use if applicable. They will also be asked to complete a short questionnaire on well-being (SF-12) once per month, which will be evaluated at the end of the study. No interim contact with the study coordinator is scheduled.

Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03228082

Contact: H.E.C. Muijsers, drs. 0243094069 ext 0031 hella.muijsers@radboudumc.nl
Contact: A.H.E.M. Maas, Prof.dr. 0243614533 ext 0031 onderzoekhellp.cardio@radboudumc.nl

Katholisches Karl-Leisner-Klinikum GmbH Not yet recruiting
Kleve, Germany
Contact: S. Heiden, dr.         
Contact: L. Trnka, dr.         
Krankenhaus Bethanien Recruiting
Moers, Germany
Contact: P. Tonnies, dr.         
Contact: D. Brunotte, dr.         
St. Josef Krankenhaus GmbH Recruiting
Moers, Germany
Contact: J. Pagels, dr.         
Contact: M. Saxe, dr.         
Rijnstate Ziekenhuis Not yet recruiting
Arnhem, Netherlands
Contact: K. de Boer, dr.         
Radboudumc Recruiting
Nijmegen, Netherlands, 6500 HB
Contact: H.E.C. Muijsers, drs.    +31243094069    hella.muijsers@radboudumc.nl   
Principal Investigator: A.H.E.M. Maas, Professor         
Sub-Investigator: H.E.C. Muijsers, drs.         
Sub-Investigator: O.W.H. van der Heijden, dr.         
Sub-Investigator: N. Roeleveld, Professor         
Sub-Investigator: J. Lancee         
Canisius-Wilhelmina Ziekenhuis Not yet recruiting
Nijmegen, Netherlands, 6532 SZ
Contact: C.D. van Bijsterveldt, dr         
Sponsors and Collaborators
Radboud University
Principal Investigator: A.H.E.M. Maas, Prof.dr. Radboudumc, department Cardiology

Writing Group Members, Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, Das SR, de Ferranti S, Després JP, Fullerton HJ, Howard VJ, Huffman MD, Isasi CR, Jiménez MC, Judd SE, Kissela BM, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Magid DJ, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Rosamond W, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee; Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2016 Update: A Report From the American Heart Association. Circulation. 2016 Jan 26;133(4):e38-360. doi: 10.1161/CIR.0000000000000350. Epub 2015 Dec 16. Erratum in: Circulation. 2016 Apr 12;133(15):e599.
Piepoli MF, Hoes AW, Agewall S, Albus C, Brotons C, Catapano AL, Cooney MT, Corrà U, Cosyns B, Deaton C, Graham I, Hall MS, Hobbs FDR, Løchen ML, Löllgen H, Marques-Vidal P, Perk J, Prescott E, Redon J, Richter DJ, Sattar N, Smulders Y, Tiberi M, van der Worp HB, van Dis I, Verschuren WMM, Binno S; ESC Scientific Document Group . 2016 European Guidelines on cardiovascular disease prevention in clinical practice: The Sixth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of 10 societies and by invited experts)Developed with the special contribution of the European Association for Cardiovascular Prevention & Rehabilitation (EACPR). Eur Heart J. 2016 Aug 1;37(29):2315-2381. doi: 10.1093/eurheartj/ehw106. Epub 2016 May 23.

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT03228082     History of Changes
Other Study ID Numbers: NL59836.091.16
First Posted: July 24, 2017    Key Record Dates
Last Update Posted: July 24, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Radboud University:
Patient empowerment
Women's Health
Home Blood Pressure Monitoring

Additional relevant MeSH terms:
Cardiovascular Diseases
Hypertension, Pregnancy-Induced
Pregnancy Complications