Esomeprazole Alone or With Sildenafil Citrate in Women With Early-onset Preeclampsia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Prolongation of gestation measured from the time of enrollment to the time of delivery.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
both participants and researchers will be blinded to the intervention given
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Esomeprazole with Sildenafil Citrate (Drug)
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
干预措施: Sildenafil Citrate (Drug)
Esomeprazole alone plus 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
干预措施: Esomeprazole with Sildenafil Citrate (Drug)
Esomeprazole alone plus 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
干预措施: Placebo to Sildenafil Citrate (Drug)
placebo to Esomeprazole plus 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
干预措施: Placebo to Esomeprazole (Drug)
placebo to Esomeprazole plus 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
干预措施: Placebo to Sildenafil Citrate (Drug)
结局指标
主要结局
Prolongation of gestation measured from the time of enrollment to the time of delivery.
时间窗: 3 weeks
Prolongation of gestation measured from the time of enrollment to the time of delivery
次要结局
- Severe morbidity(4 weeks)
- Side effects(4 weeks)
- The change in serum level of sFlt-1 and endoglin before the start of treatment and at termination of pregnancy(4 weeks)
研究者
hany farouk
Principal Investigator
Aswan University Hospital