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Maternal haemodynamics in Hypertensive Disorders of Pregnancy under antihypertensive therapy (HyperDiP): study protocol for a prospective observational case-control study.

Palmrich, P; Haase, N; Sugulle, M; Kalafat, E; Khalil, A; Binder, J (2023) Maternal haemodynamics in Hypertensive Disorders of Pregnancy under antihypertensive therapy (HyperDiP): study protocol for a prospective observational case-control study. BMJ Open, 13 (6). e065444. ISSN 2044-6055 https://doi.org/10.1136/bmjopen-2022-065444
SGUL Authors: Khalil, Asma

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Abstract

INTRODUCTION: Hypertensive disorders of pregnancy (HDP) are associated with a high incidence of maternal and perinatal morbidity and mortality. HDP, in particular pre-eclampsia, have been determined as risk factors for future cardiovascular disease. Recently, the common hypothesis of pre-eclampsia being a placental disorder was challenged as numerous studies show evidence for short-term and long-term cardiovascular changes in pregnancies affected by HDP, suggesting a cardiovascular origin of the disease. Despite new insights into the pathophysiology of HDP, concepts of therapy remain unchanged and evidence for improved maternal and neonatal outcome by using antihypertensive agents is lacking. METHODS AND ANALYSIS: A prospective observational case-control study, including 100 women with HDP and 100 healthy controls, which will assess maternal haemodynamics using the USCOM 1A Monitor and Arteriograph along with cardiovascular markers (soluble fms-like kinase 1/placental-like growth factor, N-terminal pro-B type natriuretic peptide) in women with HDP under antihypertensive therapy, including a follow-up at 3 months and 1 year post partum, will be conducted over a 50-month period in Vienna. A prospective, longitudinal study of cardiovascular surrogate markers conducted in Oslo will serve as a comparative cohort for the Vienna cohort of haemodynamic parameters in pregnancy including a longer follow-up period of up to 3 years post partum. Each site will provide a dataset of a patient group and a control group and will be assessed for the outcome categories USCOM 1A measurements, Arteriograph measurements and Angiogenic marker measurements. To estimate the effect of antihypertensive therapy on outcome parameters, ORs with 95% CIs will be computed. Longitudinal changes of outcome parameters will be compared between normotensive and hypertensive pregnancies using mixed-effects models. ETHICS AND DISSEMINATION: Ethical approval has been granted to all participating centres. Results will be published in international peer-reviewed journals and will be presented at national and international conferences.

Item Type: Article
Additional Information: © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ. https://creativecommons.org/licenses/by/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
Keywords: Hypertension, Maternal medicine, Ultrasonography, Infant, Newborn, Female, Pregnancy, Humans, Pre-Eclampsia, Hypertension, Pregnancy-Induced, Antihypertensive Agents, Case-Control Studies, Prospective Studies, Longitudinal Studies, Placenta, Hemodynamics, Observational Studies as Topic, Placenta, Humans, Hypertension, Pregnancy-Induced, Pre-Eclampsia, Antihypertensive Agents, Case-Control Studies, Longitudinal Studies, Prospective Studies, Pregnancy, Infant, Newborn, Female, Hemodynamics, Observational Studies as Topic, 1103 Clinical Sciences, 1117 Public Health and Health Services, 1199 Other Medical and Health Sciences
SGUL Research Institute / Research Centre: Academic Structure > Molecular and Clinical Sciences Research Institute (MCS)
Journal or Publication Title: BMJ Open
ISSN: 2044-6055
Language: eng
Dates:
DateEvent
1 June 2023Published
16 May 2023Accepted
Publisher License: Creative Commons: Attribution 4.0
Projects:
Project IDFunderFunder ID
I 4149-Bustrian, German and Norwegian Research fundUNSPECIFIED
01KL1911ustrian, German and Norwegian Research fundUNSPECIFIED
297333ustrian, German and Norwegian Research fundUNSPECIFIED
PubMed ID: 37263704
Go to PubMed abstract
URI: https://openaccess.sgul.ac.uk/id/eprint/115682
Publisher's version: https://doi.org/10.1136/bmjopen-2022-065444

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