American Journal of Obstetrics and Gynecology
Oral Concurrent 3Thursday, February 1 • 1:15 PM - 4:00 PM • Grand Ballroom D-E34: The Pre-eclampsia Intervention with Esomeprazole trial (PIE trial)
Section snippets
Objective
Preeclampsia is a major pregnancy complication globally responsible for thousands of deaths. We have shown in preclinical studies that esomeprazole can potently decrease sFlt secretion and mitigate endothelial dysfunction. We therefore set out to examine whether esomeprazole could prolong pregnancy in women diagnosed with very preterm preeclampsia.
Study Design
We performed a double blind, randomised, placebo controlled trial at Tygerberg Hospital in South Africa. Women with a singleton pregnancy who were diagnosed with preterm preeclampsia (gestational age (GA) of 26+0 to 31+6) were randomised (stratified to GA above or below 29 weeks) to 40 mg daily esomeprazole or an identical placebo until delivery. The primary outcome was prolongation of gestation. Secondary outcomes included maternal and neonatal composites and individual outcomes. Serial
Results
Between January 2016 and April 2017 we randomised 120 women. One participant was excluded due to incorrect randomisation (59 esomeprazole vs 60 placebo). Baseline characteristics were comparable with a median GA at enrolment of 29+4 weeks in both groups. Mean time from randomisation to delivery was 12.9 days in the esomeprazole group versus 13.1 days in the placebo group (P-value 0,92, Figure 1). Secondary outcomes are shown in Table 1. There was a statistically significant reduction in the
Conclusion
In women with preterm preeclampsia, 40 mg daily esomeprazole did not prolong pregnancy.