Pravastin as a new treatment at high risk women for preterm preeclampsia: a controlled, randomized, double-blind, clinical trial
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Background
Preeclampsia complicates approximately 3% to 5% of pregnancies and remains a major
cause of neonatal and maternal morbimortality. The pathophysiological similarities with adult
cardiovascular disease, risk factors and its pleiotropic effects give an important role to
Pravastatin, a hydrophilic 3-hydroxy-3-methyl-glutaryl-coenzyme A reductase inhibitor. This
statin has shown in preclinical studies and pilot clinical trials compares to placebo, to restore
several pathogenic pathways associated with preeclampsia, providing biological feasibility and
security for its use for preeclampsia. Although many therapeutic interventions have been
proposed, aspirin is the only prevent method with clinical evidence that seems to decrease
the incidence of the disease. Nevertheless, mortality and morbidity rates still remain
considerable.
Objective
The aim of this study is to determine the efficacy of Pravastatin compared to Aspirin
treatment in pregnant women at high risk for preterm preeclampsia. We are interested in
finding as well clinical severity differences depending on patient’s treatment when episodes
are happening by measuring analytical parameters (thrombocytopenia and seric creatinine
level).
Study design
It will be a multicentre, controlled, randomized, double-blind clinical trial involving women at
high-risk for preterm preeclampsia. It will be executed at Hospital Universitari Josep Trueta
of Girona, Hospital Universitari de Vall’Hebron, Hospital Sant Pau, Hospital Sant Joan de Déu
of Barcelona, Hospital Germans Trias i Pujol of Badalona, Hospital Arnau de Vilanova of
Lleida and Hospital Universitari Joan XXIII of Tarragona.
Methods
An estimated sample size of 4.646 women with singleton and non-anomalous pregnancies
older than 18 years of age that they are at a high risk of preterm preeclampsia at first
trimester will be assigned to daily aspirin 150 mg (Group 1) or pravastatin 10 mg (Group 2)
by oral administration before going to bed until 36 weeks of gestational age.
The study will be approximately conducted in four years
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