Previous studies have shown that expectant management of preeclampsia in the context of extreme prematurity may improve perinatal outcomes. Indeed, it has been estimated that for each additional day of pregnancy prolongation between 24 and 32 weeks of gestation, there is a nonlinear corresponding gain of 1% in fetal survival. In this study, we evaluate the use of Esomeprazole alone or with Sildenafil Citrate for the treatment of singleton pregnancies complicated by preeclampsia. We hypothesized that the potential increase in uteroplacental and fetoplacental blood flow with the use of Esomeprazole alone or with Sildenafil Citrate may be associated with pregnancy prolongation (the primary study outcome) and improved maternal and perinatal outcomes.
The etiology and pathophysiology of preeclampsia have not been clearly established; impaired immunologic adaptation and genetic incompatibility seem to be involved in deficient trophoblastic implantation. Placental hypoxia and endothelial dysfunction may lead to preeclampsia through an exacerbated systemic inflammatory reaction. Increased placental expression and secretion of soluble fms-like tyrosine kinase 1 appear to play a central role in the pathogenesis of preeclampsia. The soluble fms-like tyrosine kinase 1 antagonizes the proangiogenic biologic activity of circulating vascular endothelial growth factor and placental growth factor, leading to a failure of nitric oxide signaling to smooth muscle The investigators will conduct a randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of Esomeprazole alone or with Sildenafil Citrate in preterm pregnancies complicated by preeclampsia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
180
Patients will take esomeprazole single dose of 40 mg orally once a day
Patients will take Sildenafil Citrate 40mg every 8 hours
Patients will take inert tablets similar in appearance, color, and consistency to esomeprazole single dose of 40 mg orally once a day
Patients will take inert tablets similar in appearance, color, and consistency to Sildenafil Citrate 40mg every 8 hours
Aswan University
Aswān, Egypt
RECRUITINGProlongation of gestation measured from the time of enrollment to the time of delivery.
Prolongation of gestation measured from the time of enrollment to the time of delivery
Time frame: 3 weeks
Severe morbidity
Severe morbidity including eclampsia, liver or renal failure, hemolysis, elevated liver enzymes and low platelets syndrome (HELLP), disseminated intravascular coagulation (DIC), stroke, and pulmonary edema
Time frame: 4 weeks
Side effects
any side effects or adverse events related to the intervention, intervention stopped due to side effects
Time frame: 4 weeks
The change in serum level of sFlt-1 and endoglin before the start of treatment and at termination of pregnancy
The change in serum level of sFlt-1 and endoglin before the start of treatment and at termination of pregnancy
Time frame: 4 weeks
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