Pravastin as a new treatment at high risk women for preterm preeclampsia: a controlled, randomized, double-blind, clinical trial

Abstract

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