Effect of Rosuvastatin on Sever Preeclampsia Induced Inflammatory Response
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 主要终点
- the effect of rosuvastatin on the clinical features of preeclampsia
研究概览
简要总结
The primary outcome will be the effect of rosuvastatin on the resolution of biochemical features associated with severe PE (↑CRP and IL6).
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详细描述
Preeclampsia is a multisystem disorder that complicates 3-5% of pregnancies and remains a major cause of maternal, fetal, and neonatal morbidity and mortality.(1)
Preeclampsia is characterized by the development of new onset hypertension (HTN) and the establishment of proteinuria. Other signs and symptoms that accompany the disease include: headache, visual disturbances, epigastric or abdominal pain, weakness, altered mental status, HELLP syndrome (2) dyspnea and edema (American College of Obstetricians and Gynecologists and Task Force on Hypertension in Pregnancy, 2013).
Previous preeclamptic pregnancy, family history of preeclampsia, late age of maternity (>40 years), multiple gestation, obesity, diabetes mellitus and history of thrombophilia have been identified as predisposing risk factors (American College of Obstetricians and Gynecologists and Task Force on Hypertension in Pregnancy, 2013). In particular, the presence of HTN and chronic renal impairment before gestation has been strongly correlated to the development of preeclampsia later during pregnancy (Foo et al., 2015).
Preeclampsia can result in a great number of severe and, in some cases, fatal short- and long-term consequences affecting both the mother and the fetus. Maternal complications include cardiometabolic disorders (diabetes, ischemic heart disease, metabolic syndrome), cerebrovascular disease (stroke, intracranial bleeding), neurologic abnormalities (eclamptic seizures) and renal impairment (Ramsay et al., 2003; Wilson et al., 2003; Haukkamaa et al., 2004; Funai et al., 2005).
Fetal outcomes include intrauterine growth restriction (IUGR), prematurity and higher risk of developing HTN, obesity, metabolic syndrome, dyslipidemias, and cardiovascular disease (Lo et al., 2013; Nice guidelines, 2016).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
computer generated randomization will be conducted in a Women's Health Hospital, Assuit University. Neither the doctor "investigator" nor the participant "parturient" will be aware of the group allocation or the drug used. The study drugs will be prepared by one of the supervisor anesthesia (not included in the procedure, observation or in data collection)
入排标准
- 年龄范围
- 20 Years 至 35 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age: 20-35 years.
- •Singleton nonanomalous pregnancy (confirmed with an ultrasound examination).
- •Normal lipid profile and normal liver transaminases.
- •WBCs (4-11*103/mm3).
- •CRP < 3 mg/L.
排除标准
- •Parturient's refusal.
- •Women with history of cardiac, respiratory, renal, neurologic or endocrine diseases.
- •Contraindications for statin therapy (eg, hypersensitivity to rosuvastatin, recent or active liver disease).
- •Concomitant therapy with fibrates, niacin, cyclosporine, clarithromycin, or erythromycin.
- •Inability to tolerate oral medications secondary to severe nausea and vomiting of pregnancy.
- •Multifetal gestation or fetal demise.
- •Fetal abnormalities.
- •Emergency surgeries.
研究组 & 干预措施
Group 1
40 preeclamptic parturient receive 20 mg rosuvastatin orally once daily.
干预措施: rosuvastatin (Drug)
Group 2
40 preeclamptic parturient receive 40 mg rosuvastatin orally once daily.
干预措施: rosuvastatin (Drug)
结局指标
主要结局
the effect of rosuvastatin on the clinical features of preeclampsia
时间窗: baseline
The primary outcome will be the effect of rosuvastatin on the resolution of biochemical features associated with severe PE (↑CRP and IL6).
次要结局
未报告次要终点
研究者
Sara Mansour
assistant lecturer on anasthesia and icu department
Assiut University
