ISRCTN17787139已完成3 期
RandomiSed conTrolled trial with prAvasTatin versus placebo for preventIoN of preeclampsia
Health Foundation for Education and Research in the Region of Murcia (Fundación para la Formación e Investigación Sanitaria)0 个研究点目标入组 1,684 人开始时间: 2015年11月18日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,684
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Age > 18 years
- •2. Singleton pregnancies
- •3. Live fetus at 11-13 weeks' of gestation
- •4. High-risk for preterm-PE at 11-13 weeks by the algorithm combining maternal history and characteristics, biophysical findings (mean arterial pressure and uterine artery Dopplers) and biochemical factors (placental growth factor)
- •5. English or Spanish speaking (otherwise interpreters will be used)
- •6. Informed and written consent
排除标准
- •1. Statin use in current pregnancy (administration must have ceased >28 days prior to randomisation)
- •2. Pregnancies complicated by major fetal abnormality identified at the 11-13 weeks assessment
- •3. Women who are unconscious or severely ill, those with learning difficulties, or serious mental illness
- •4. Women with contraindications for statin therapy
- •5. Hypersensitivity to Pravastatin or any component of the product
- •6. Active liver disease in the past 6 months (acute hepatitis, chronic active hepatitis) by medical history
- •7. Unexplained elevations (1.5x normal) of serum transaminases (ALT and AST), confirmed either by available blood results within the recruiting hospital in the last 6 months or blood taken prior to randomisation or jaundice
- •8. Women with any of the following conditions as it may predispose them to adverse events or side effects
- •9. Current (last 28 days) heavy alcohol use defined as =2 drinks per day
- •10. Illicit drug use
- •11. Amyotrophic lateral sclerosis (ALS)
- •12. Concomitant therapy with amiodarone, azole antifungals, diltiazem, gemfibrozil, nefazodone, nicotinic acid, protease inhibitors, efavirenz (non-nucleoside reverse transcriptase inhibitior), verapamil, fibrates, niacin (vitamin B3), cyclosporin, clarithromycin or erythromycin or other macrolide antibiotics
- •13. History of cholestasis of the liver in prior pregnancy
- •14. Personal or family history of myopathy or rhabdomyolysis
- •15. Women with any of the following medical conditions as described in medical record or patient history
- •16. Pregestational diabetes mellitus
- •17. Status post solid organ transplant
- •18. Chronic renal disease/insufficiency with baseline serum creatinine =1.5 mg/dL
- •19. Epilepsy or other seizure disorder
- •20. Uterine malformations
- •21. Cancer
- •22. Heart disease including prior myocardial infarction and prior cerebrovascular accident.
- •23. Concurrent and chronic (>6 months) use of medications with potential drug interactions with statins such as immunosuppressive drugs, gemfibrozil, niacin, erythromycin, itraconazole, cholestyramine, digoxin, rifampicin (Patients will not be excluded if the drug has been discontinued)
- •24. Inability to tolerate oral medications secondary to severe nausea and vomiting of pregnancy
- •25. Participating in another intervention study that influences maternal and fetal morbidity and mortality
- •26. Plans to deliver in a non-network site
- •27. Any other reason the clinical investigators think will prevent the potential participant from complying with the trial protocol
研究者
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