Abstract:

Objectives: To evaluate the effect of Esomeprazole on prolongation of gestation in patients with early onset preeclampsia (EOPE).

Methods: A randomized, triple-blind, placebo-controlled study (NCT03213639) was conducted in a tertiary University hospital between March 2018 and July 2020. Patients diagnosed as PE without severe features were included if they carry singleton pregnancy between 26 and 32 weeks. We randomly assigned all participants in a 1:1 ratio into one of two groups: esomeprazole group: patients was given single dose of Esomeprazole 40 mg orally once a day and placebo group: patients was given an inert placebo tablet. The primary outcome is the prolongation of gestation measured from the time of enrolment to the time of delivery in days.

Results: The study included 205 patients assigned into esomeprazole group (n=102) and placebo group (n=103). The mean gestational age at inclusion was 29.6±1.6 weeks in esomeprazole group vs. 30.1±1.2 weeks in the placebo group (p=0.113). Kaplan-Meier survival analysis of patients from randomization until termination of pregnancy was done. The mean survival time for Esomeprazole group was slightly longer than placebo group (10.8±9.7 [95% CI= 8.9, 12.7] vs. 10.6 ± 6.7 [95% CI= 9.3, 11.9]) but this difference was statistically not significant (p=0.461). There was no statistically significant difference in the rate of maternal or fetal complications between both groups.

Conclusions: Esomeprazole has no effect on prolongation of the duration of gestation in patients with EOPE. Furthermore, it has no effect on decreasing the rate of maternal or fetal complications