Esomeprazole With Sildenafil Citrate in Women With Early-onset Preeclampsia
- Conditions
- Preeclampsia
- Interventions
- Drug: Placebo to Esomeprazole
- Registration Number
- NCT03724838
- Lead Sponsor
- Aswan University Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 180
- Pregnant women presenting at a Gestational age between 28 + 0 weeks and 32 + 0 weeks presented with preterm preeclampsia
- The patient will be managed with an expectant management
- Give written informed consent
- Multiple pregnancies.
- Previous hypersensitivity reaction esomeprazole or sildenafil citrate
- Contraindications to the use of esomeprazole or sildenafil citrate
- The patient is unable or unwilling to give consent
- An established fetal compromise that necessitates delivery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Esomeprazole with Sildenafil Citrate Esomeprazole with Sildenafil Citrate Patients will take esomeprazole single dose of 40 mg orally once a day plus three doses of Sildenafil Citrate 40mg orally every 8 hours Esomeprazole with Sildenafil Citrate Sildenafil Citrate Patients will take esomeprazole single dose of 40 mg orally once a day plus three doses of Sildenafil Citrate 40mg orally every 8 hours Esomeprazole alone plus placebo to Sildenafil Citrate Placebo to Sildenafil Citrate Patients will take esomeprazole single dose of 40 mg orally once a day plus three doses of placebo identical in shape and consistency withSildenafil Citrate 40mg orally every 8 hours placebo to Esomeprazole plus placebo to Sildenafil Citrate Placebo to Esomeprazole Patients will take placebo identical in shape and consistency with esomeprazole single dose of 40 mg orally once a day plus three doses of placebo identical in shape and consistency withSildenafil Citrate 40mg orally every 8 hours placebo to Esomeprazole plus placebo to Sildenafil Citrate Placebo to Sildenafil Citrate Patients will take placebo identical in shape and consistency with esomeprazole single dose of 40 mg orally once a day plus three doses of placebo identical in shape and consistency withSildenafil Citrate 40mg orally every 8 hours Esomeprazole alone plus placebo to Sildenafil Citrate Esomeprazole with Sildenafil Citrate Patients will take esomeprazole single dose of 40 mg orally once a day plus three doses of placebo identical in shape and consistency withSildenafil Citrate 40mg orally every 8 hours
- Primary Outcome Measures
Name Time Method Prolongation of gestation measured from the time of enrollment to the time of delivery. 3 weeks Prolongation of gestation measured from the time of enrollment to the time of delivery
- Secondary Outcome Measures
Name Time Method Severe morbidity 4 weeks 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
Side effects 4 weeks any side effects or adverse events related to the intervention, intervention stopped due to side effects
The change in serum level of sFlt-1 and endoglin before the start of treatment and at termination of pregnancy 4 weeks The change in serum level of sFlt-1 and endoglin before the start of treatment and at termination of pregnancy
Trial Locations
- Locations (1)
Aswan University
🇪🇬Aswan, Egypt