Hella E C Muijsers1, Olivier W H van der Heijden2, Karin de Boer3, Chantal van Bijsterveldt4, Ciska Buijs5, Jens Pagels6, Peter Tönnies7, Susanne Heiden8, Nel Roeleveld9, Angela H E M Maas10. 1. Department of Cardiology, Radboud university medical center, Geert-Grooteplein Zuid 10, 6525, GA, Nijmegen, The Netherlands. Hella.Muijsers@radboudumc.nl. 2. Department of Obstetrics and Gynecology, Radboud university medical center, Geert-Grooteplein Zuid 10, 6525, GA, Nijmegen, The Netherlands. 3. Department of Obstetrics and Gynecology, Rijnstate, Wagnerlaan 55, 6815, AD, Arnhem, The Netherlands. 4. Department of Obstetrics and Gynecology, Canisius-Wilhelmina Hospital, Weg door Jonkerbos 100, 6532, SZ, Nijmegen, The Netherlands. 5. Department of Obstetrics and Gynecology, Maasziekenhuis Pantein, Dokter Kopstraat 1, 5835 BV, Beugen, The Netherlands. 6. Department of Obstetrics and Gynecology, St. Josef Hospital Moers, Asberger Strasse 4, 47441, Moers, Germany. 7. Department of Obstetrics and Gynecology, Bethanien Hospital Moers, Bethanienstrasse 21, 47441, Moers, Germany. 8. Department of Obstetrics and Gynecology, St. Antonius Hospital Kleve, Albersallee 5-7, 47533, Kleve, Germany. 9. Department for Health Evidence, Radboud Institute for Health Sciences, Radboud university medical center, Geert-Grooteplein Zuid 10, 6525, GA, Nijmegen, The Netherlands. 10. Department of Cardiology, Radboud university medical center, Geert-Grooteplein Zuid 10, 6525, GA, Nijmegen, The Netherlands.
Abstract
BACKGROUND:Hypertensive disorders of pregnancy (HDP), such as preeclampsia (PE) or the Hemolysis Elevated Liver enzymes and Low Platelets (HELLP) syndrome are associated with elevated cardiovascular disease (CVD) risks, but standardized prevention guidelines after such pregnancies are lacking. Hypertension is the first emerging risk factor after PE/HELLP pregnancies and is a major risk factor for CVD. Hypertension before the age of 55 years may lead to various manifestations of end-organ damage at relatively young age. Therefore, timely treatment of elevated blood pressure is mandatory, but many of these high-risk women have long-term undetected and untreated hypertension before adequate treatment is initiated. AIM: The aim of our study is to assess whether home blood pressure monitoring (HBPM) in women with a previous PE/HELLP pregnancy is a valuable tool for the early detection of hypertension. METHODS:Women with a history of both early and late PE/HELLP syndrome aged 40-60 years are invited to participate. Patients with a history of CVD, known hypertension and/or use of antihypertensive medication are excluded. Women are randomized between HPBM or 'usual care'. The primary outcome is feasibility and usability of HBPM after 1 year of follow-up. Secondary outcomes will be the effectiveness of HPBM to detect hypertension, the efficacy of BP treatment, quality of life, health-related symptoms, work ability, and life-style behaviour. The results of this study will provide better strategies for timely detection and prevention of hypertension in women after PE/HELLP. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03228082. Registered June 15, 2017.
RCT Entities:
BACKGROUND:Hypertensive disorders of pregnancy (HDP), such as preeclampsia (PE) or the Hemolysis Elevated Liver enzymes and Low Platelets (HELLP) syndrome are associated with elevated cardiovascular disease (CVD) risks, but standardized prevention guidelines after such pregnancies are lacking. Hypertension is the first emerging risk factor after PE/HELLP pregnancies and is a major risk factor for CVD. Hypertension before the age of 55 years may lead to various manifestations of end-organ damage at relatively young age. Therefore, timely treatment of elevated blood pressure is mandatory, but many of these high-risk women have long-term undetected and untreated hypertension before adequate treatment is initiated. AIM: The aim of our study is to assess whether home blood pressure monitoring (HBPM) in women with a previous PE/HELLP pregnancy is a valuable tool for the early detection of hypertension. METHODS:Women with a history of both early and late PE/HELLP syndrome aged 40-60 years are invited to participate. Patients with a history of CVD, known hypertension and/or use of antihypertensive medication are excluded. Women are randomized between HPBM or 'usual care'. The primary outcome is feasibility and usability of HBPM after 1 year of follow-up. Secondary outcomes will be the effectiveness of HPBM to detect hypertension, the efficacy of BP treatment, quality of life, health-related symptoms, work ability, and life-style behaviour. The results of this study will provide better strategies for timely detection and prevention of hypertension in women after PE/HELLP. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03228082. Registered June 15, 2017.