Use of Esomeprazole in Treatment of Early Onset Preeclampsia:a Double Blind Randomized, Placebo-controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 205
- 试验地点
- 1
- 主要终点
- The change in serum level of sFlt-1 and endoglin before the start of treatment and at termination of pregnancy
研究概览
简要总结
Pre-eclampsia is one of the most serious complications of pregnancy affecting 3-8 % of pregnancies worldwide. It is a multi-system disorder involving maternal vessels (causing hypertension and endothelial dysfunction), the kidneys, the liver, the lungs, the hematological system, the cardiovascular system and the feto-placental unit. In its most severe form, it affects the brain, causing seizures (eclampsia), cerebro-vascular events and even death.
详细描述
The key aspects in the pathophysiology of pre-eclampsia are placental oxidative stress (and hypoxia), placental release of the anti-angiogenic factors Soluble Fms Like Tyrosine Kinase -1 and soluble endoglin and maternal endothelial dysfunction. A drug that can counter these pathological steps could be a strategy to treat pre-eclampsia.
If an affordable and safe treatment was available it could temporize the disease progression of pre-eclampsia thereby delaying delivery to gain gestation. This could save the lives of many infants and decrease the hospital burden caused by iatrogenic prematurity.
Currently, there are trials investigating the possible use of pravastatin to treat pre-eclampsia, and to prevent it There are no other significant trials of orally available small molecules to treat pre-eclampsia that we are aware of.
The Translational Obstetrics Group at Melbourne University has generated strong preclinical evidence suggesting esomeprazole as one of the proton pump inhibitors may have potent actions giving it significant potential as a treatment for pre-eclampsia
Proton pump inhibitors have been commonly used in pregnancy to treat gastroesophageal reflux disorders and more serious gastrointestinal complications like Helicobacter pylori-infection, peptic and duodenal ulcers and Zollinger-Ellison syndrome.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Gestational age between 28 + 0 weeks and 31 + 6 weeks
- •Estimated fetal weight by ultrasound between 500 gm and 1800 gm (if gestation is not certain).
- •Singleton pregnancy.
- •The patient will be managed with expectant management.
排除标准
- •Patient is unable or unwilling to give consent
- •Established fetal compromise that necessitates delivery.
- •The presence of any of the following at presentation:
- •Eclampsia.
- •Severe hypertension.
- •Cerebrovascular event as an ischaemic or haemorrhagic stroke.
- •Renal impairment.
- •Signs of left ventricular failure which include pulmonary oedema.
- •Disseminated intravascular coagulation (DIC)
- •Haemolysis, elevated liver enzymes and low platelets (HELLP syndrome)
- •Fetal distress on cardiotocography
- •Contra-indications for expectant management of pre-eclampsia
- •Current use of a proton pump inhibitor
- •Contraindications to the use of a proton pump inhibitor
- •Previous hypersensitivity reaction to a proton pump inhibitor
研究组 & 干预措施
study group
Patients will take esomeprazole single dose of 40 mg orally once a day
干预措施: Esomeprazole 40 mg Oral Tablet (Drug)
control group
Patients will take an inert tablet similar in appearance, color and consistency
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
The change in serum level of sFlt-1 and endoglin before the start of treatment and at termination of pregnancy
时间窗: 2 weeks
Number of women who develop HELLP syndrome
时间窗: 1 month
次要结局
- Prolongation of gestation measured from the time of enrollment to the time of delivery(2 weeks)
- The side effects of the drugs(2 weeks)
研究者
Ahmed Mohamed Abbas
Principal investigator
Assiut University