Preeclampsia Intervention with Esomeprazole (PIE) trial - Trial PACTR201504000771349

Timeline & Enrollment

Summary

Preeclampsia is one of the most serious complications of pregnancy, globally responsible for 60,000 maternal deaths per year, and far more fetal deaths. Once diagnosed, there are no drugs that can slow disease progression and delivery is the only cure. Esomeprazole is a proton pump inhibitor commonly used for the treatment of gastric acid-related disorders. These medications have been widely used in pregnancy for these indications and maternal and fetal safety is well establishedWe have generated preclinical data to suggest proton pump inhibitors may be candidate therapeutics to treat preeclampsia. We found proton pump inhibitors: 1. Potently decrease the release of soluble endoglin (sEng) and soluble Fms-like Tyrosine Kinase 1 (sFlt-1) from both primary placental tissue and primary endothelial cells in vitro. These are anti-angiogenic factors released from the placenta and thought to play a central role in the pathogenesis of preeclampsia.2. Potently upregulate heme oxygenase-1, a potent ¿cytoprotective¿ molecule in the placenta.3. Potently decrease endothelial dysfunction in in vitro assays. In South Africa, severe pre-eclampsia is extremely common, and limited access to tertiary neonatal care means that severe pre-eclampsia is managed conservatively with close surveillance until 34 weeks gestation. This creates a unique opportunity to test our hypothesis that esomeprazole could slow disease progression in severe early onset pre-eclampsia, allowing the fetus to safely gain gestation. If proven, it could be the first successful treatment for preeclampsia.Objectives:To examine whether 40mg of esomeprazole given to women with severe ealry onset preeclampsia can 1.prolong gestation for 5 days2.significantly decrease sFlt and/or sEng3. improve maternal and fetal outcomes4. be tolerated by baby and mother and is safe

ICD-10 Classifications