Preeclampsia
Conditions
Keywords
Esomeprazole, Sildenafil Citrate, preterm preeclampsia
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.
Interventions
DRUGEsomeprazole with Sildenafil Citrate
Patients will take esomeprazole single dose of 40 mg orally once a day
DRUGSildenafil Citrate
Patients will take Sildenafil Citrate 40mg every 8 hours
DRUGPlacebo to Esomeprazole
Patients will take inert tablets similar in appearance, color, and consistency to esomeprazole single dose of 40 mg orally once a day
DRUGPlacebo to Sildenafil Citrate
Patients will take inert tablets similar in appearance, color, and consistency to Sildenafil Citrate 40mg every 8 hours
Sponsors
Aswan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
both participants and researchers will be blinded to the intervention given
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Egypt
Contacts
Primary Contacthany f sallam
Outcome results
None listed