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.
Highlights
Preeclampsia is a disorder of widespread vascular endothelial malfunction and vasospasm that occurs after 20 weeks' gestation and can present as late as 4-6 weeks postpartum.[1]
All patients were followed until termination of pregnancy; in the esomeprazole group, three patients were lost to follow-up versus one patient in the placebo group. (Figure 1)
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), this difference was not statistically significant (P=0.515)
Summary
Preeclampsia is a disorder of widespread vascular endothelial malfunction and vasospasm that occurs after 20 weeks' gestation and can present as late as 4-6 weeks postpartum.[1] Among all cases of preeclampsia, only 10% occur in pregnancies of less than 34 weeks gestation. The global incidence of preeclampsia has been estimated to affect 5-14% of all pregnancies. The incidence of the disease is reported to be 4-18%.2,3. Preeclampsia is responsible for more than 60,000 maternal deaths annually.[4] while early delivery of patients with preeclampsia can reduce maternal mortality, it has adverse consequences for the babies delivered. Fetuses delivered at less than 33 weeks' gestation are at significant risk of severe disability, including cerebral palsy, stroke (intracerebral bleeding), retinopathy of prematurity, chronic lung disease and death.[5]
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