A Prospective, Pre-ecLampsia/Eclampsia Prevention IntervEntion

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Preeclampsia is a common, serious complication of pregnancy, affecting 5-8% of pregnancies. It is responsible for 70,000 maternal and 500,000 infant deaths globally every year, with this burden largely shouldered by lower-middle income populations. Currently there is no medical treatment for preeclampsia and the only way to stop disease progression is delivery of the pregnancy. When this occurs at early gestations, the serious potential complications of prematurity are inflicted on the newborn. The establishment of a safe preventative treatment for preeclampsia would therefore be a major advance in the clinical care of pregnant women and their babies. Laboratory work undertaken by the Translational Obstetrics Group at the University of Melbourne has shown that Proton Pump Inhibitor (PPI) drugs may play an important role in preventing or treating preeclampsia. Esomeprazole, was shown to be particularly effective at reducing high blood pressure associated with preeclampsia in animal studies and when tested on donated human placental tissues. The drugs were also observed to reduce and partially reverse damage to the blood vessel linings (endothelium) caused by preeclampsia. Another study has shown that women who have a high risk of developing preeclampsia and are coincidentally taking PPIs have lower levels of preeclampsia biomarkers present in their bloodstream than other high-risk women who are not taking PPIs. In large studies of >1,000,000 pregnant women, PPIs (commonly prescribed in pregnancy to treat symptoms of acid reflux) have been shown to be safe to take, with no increase in the risk of fetal malformation (structural damage to the baby), premature birth, or miscarriage. Given these promising early results, coupled with esomeprazole’s established low-risk harm profile in pregnancy, we propose to progress this concept by undertaking a clinical trial to evaluate esomeprazole as a preventative therapy for preeclampsia. We plan to recruit a total of 5,500 women with a Body Mass Index (BMI) =>30kg/m² at the time of their first hospital visit, from a number of different hospital sites in Australia, Chile and the UK, leading up to the birth of their first baby. This group of women has been chosen because they have a higher risk of developing preeclampsia than other pregnant women. We will randomly allocate these women to either receive 40mg oral esomeprazole, or an inert placebo (sugar pill), each day from recruitment until the birth of their baby. We will monitor for the diagnosis of preeclampsia in these two groups, as well as collecting information about the outcomes of the women and their babies. We will also monitor key biochemical features of preeclampsia in a subset of women who are recruited at the Mercy Hospital for Women. At the completion of this study, we hope to have sufficient evidence to justify recommending routine esomeprazole therapy as a preventative treatment for preeclampsia in pregnant women with a BMI =>30kg/m².

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