Randomised controlled trial with pravastatin versus placebo for prevention of preeclampsia (STATIN trial)
This is a double-blind randomised placebo-controlled trial for which the eligible participants will be identified by a screening study. In the participating centres, in Spain, Italy, Belgium, Romania and the UK, all women attending for their routine hospital visit in pregnancy at 35+0-36+6 weeks’ gestation will be screened to identify a high-risk group for development of preeclampsia (PE). In this visit we will record maternal characteristics and medical history, measure the maternal MAP and serum PLGF and sFLT-1 and on the basis of these results estimate the risk for PE. Women that are screened positive for PE will be invited to participate in the randomised trial of pravastatin. The aim of the trial is to examine if the prophylactic use of pravastatin from 35-37 weeks’ gestation in women at increased risk for PE can reduce the incidence and severity of the disease.
The trial is powered for a 50% reduction in incidence of term-PE from 12% in the placebo group to 6% in the pravastatin group. For a power of 90%, using a two sided test at the 5% level of significance, it is necessary to randomise 1,020 high-risk pregnancies.