Clinical trial NCT03724838: Esomeprazole With Sildenafil Citrate in Women With Early-onset Preeclampsia
Official title: Esomeprazole Alone or With Sildenafil Citrate in Women With Early-onset Preeclampsia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preeclampsia
Keywords: Esomeprazole
Sildenafil Citrate
preterm preeclampsia
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2018-10-30
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Prolongation of gestation measured from the time of enrollment to the time of delivery.
timeFrame: 3 weeks
Secondary outcomes:
measure: Severe morbidity
timeFrame: 4 weeks
measure: Side effects
timeFrame: 4 weeks
measure: The change in serum level of sFlt-1 and endoglin before the start of treatment and at termination of pregnancy
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University
Study officials:
affiliation: Aswan University Hospital
name: hany f sallam, md
role: PRINCIPAL_INVESTIGATOR
References: