Abstract
Objective: This study evaluates the effect of esomeprazole on the maternal serum levels of soluble fms-like tyrosine kinase-1 (sFlt-1) and soluble endoglin (sEng) in patients with early-onset preeclampsia.
Methods: A randomized, double-blind, placebo-controlled trial was carried out in a tertiary University hospital between March 2018, and September 2019 (Clinical Trials.Gov: NCT03213639). The study included women between 28 and 31+6 weeks gestational age who had been diagnosed as preeclampsia without severe features. They were randomly assigned in a 1:1 ratio into an esomeprazole group, which received esomeprazole 40 mg orally once a day, and a placebo group, which received one placebo tablet daily. Blood samples were obtained to assess levels of serum sFlt-1and sEng using ELISA testing. The primary outcome was the difference between the mean serum level of sFlt-1 and sEng at the start of treatment and at the termination of pregnancy in both groups.
Results: Eighty-eight patients were randomly assigned into both groups (44 in each). No statistically significant difference was found in the levels of sFlt-1 between both groups at admission and termination of pregnancy. The number of days of treatment for the esomeprazole group was slightly longer than the placebo group (11.4±9.4 vs. 10.3±6.3 days, P=0.515). No statistically significant difference in the rate of maternal and fetal complications occurred between the two groups. No side effects from the study medications were reported.
Conclusions: Esomeprazole, at the dosage used in this study did not effectively lower the serum levels of sFlt-1 and sEng in patients with early-onset preeclampsia. Furthermore, it did not prolong the duration of pregnancy, nor did it decrease maternal or fetal complications.