This study is a double-blind randomized placebo-controlled trial of 1,550 high-risk women to
assess whether daily treatment with pravastatin administered early in pregnancy reduces the
rate of a composite outcome of preeclampsia, fetal loss and maternal death. Women with a
prior history of preeclampsia with preterm delivery less than 34 weeks will be randomized to
pravastatin or placebo daily until delivery. Women will have monthly study visits during
pregnancy, a follow-up visit at 6 weeks postpartum and children will have follow-up visits at
2 and 5 years of age.
Phase:
Phase 3
Details
Lead Sponsor:
The George Washington University Biostatistics Center
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Heart, Lung, and Blood Institute (NHLBI)