ISRCTN16123934已完成未知
Randomised controlled trial with pravastatin versus placebo for prevention of preeclampsia
Fundación para la Formación e Investigación Sanitarias de la Región de Murcia0 个研究点目标入组 1,129 人开始时间: 2018年4月16日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 1,129
研究概览
简要总结
2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34162218/ (added 25/06/2021) 2023 Other publications in https://doi.org/10.3389/fphar.2023.1166123 (added 10/05/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •Current participant inclusion criteria as of 01/07/2020:
- •1. Pregnant women without established preeclampsia
- •2. Singleton pregnancy
- •3. Live fetus at 35+0-36+6 weeks’ gestation
- •4. Informed and written consent
- •5. Age =18 years
- •6. Not unconscious or very ill
- •7. No serious mental illness
- •8. No learning difficulties
- •9. Fluent in local language or translation by interpreter
- •Inclusion criteria for participant selection for RCT:
- •1. Same as for screening
- •2. Identified at screening as being at high-risk for term-PE by the algorithm combining maternal history and characteristics, MAP, PLGF and sFLT-1
- •3. Informed and written consent
- •4. No planned delivery within 7 days of planned randomisation date;
- •5. No major fetal abnormality;
- •6. No statin use within 28 days prior to randomisation;
- •7. None of the following contraindications for statin therapy:
- •7.1. Hypersensitivity to pravastatin or any component of the product
- •7.2. Lactose intolerance
- •7.3. Current or previous cancer
- •7.4. Previous solid organ transplant
- •7.5. Active liver disease (acute hepatitis, chronic active hepatitis) in the past 6 months
- •7.6. Chronic renal disease/insufficiency with baseline serum creatinine =1.5mg/dL
- •7.7. History of myopathy or rhabdomyolysis
- •7.8. ALT and/or AST levels = 2 x the upper limit of normal
- •7.9. Creatine kinase levels = 5 x the upper limit of normal
- •7.10. Concurrent and chronic (>6 months) use of medications with potential drug interactions with statins, such as immunosuppressive drugs, fibrates, gemfibrozil, therapeutic doses of niacin for hyperlipidaemia (low doses found in dietary/nutritional supplements such as pregnancy supplements may be used), protease inhibitors, efavirenz (non-nucleoside reverse transcriptase inhibitor), erythromycin, clarithromycin, itraconazole, cholestyramine, digoxin, rifampicin (patients will not be excluded if the drug has been discontinued, or is prescribed for a short duration of time)
- •7.11. Participating in another intervention study that influences the outcomes of this study
- •Previous participant inclusion criteria:
- •1. Pregnant women without established preeclampsia
- •2. Singleton pregnancy
- •3. Live fetus at 35+0-36+6 weeks’ gestation
- •4. Informed and written consent
- •5. Age >18 years
- •6. Not unconscious or very ill
- •7. No serious mental illness
- •8. No learning difficulties
- •9. Fluent in local language or translation by interpreter
- •10. No major fetal abnormality
- •11. No statin use within 28 days prior to randomisation
- •12. None of the following contraindications for statin therapy:
- •12.1. Hypersensitivity to pravastatin or any component of the product
- •12.2. Lactose intolerance
- •12.3. Current or previous cancer
- •12.4. Previous solid organ transplant
- •12.5. Active liver disease (acute hepatitis, chronic active hepatitis) in the past 6 months
- •12.6. Chronic renal disease/insufficiency with baseline serum creatinine >1.5mg/dL
- •12.7. History of myopathy or rhabdomyolysis
- •12.8. ALT and/or AST levels = 2 x the upper limit of normal
- 另有 3 项未显示
排除标准
- •Current participant exclusion criteria as of 01/07/2020:
- •For the randomised trial, same as for screening, but in addition:
- •1. Major fetal abnormality
- •2. Women with established PE
- •3. Statin use within 28 days prior to randomisation
- •4. Women with contraindications for statin therapy:
- •4.1. Hypersensitivity to pravastatin or any component of the product
- •4.2. Lactose intolerance
- •4.3. Current or previous cancer
- •4.4. Previous solid organ transplant
- •4.5. Active liver disease (acute hepatitis, chronic active hepatitis) in the past 6 months
- •4.6. Chronic renal disease/insufficiency with baseline serum creatinine = 1.5mg/dL
- •4.7. History of myopathy or rhabdomyolysis
- •4.8. ALT and/or AST levels > = 2 x the upper limit of normal
- •4.9. Creatine kinase levels > = 5 x the upper limit of normal
- •4.10. Concurrent and chronic (>6 months) use of medications with potential drug interactions with statins, such as immunosuppressive drugs, fibrates, gemfibrozil, therapeutic doses of niacin for hyperlipidaemia (low doses found in dietary/nutritional supplements such as pregnancy supplements may be used), protease inhibitors, efavirenz (non-nucleoside reverse transcriptase inhibitor), erythromycin, clarithromycin, itraconazole, cholestyramine, digoxin, rifampicin (patients will not be excluded if the drug has been discontinued, or is prescribed for a short duration of time)
- •5. Participating in another intervention study that influences the outcomes of this study
- •Previous participant exclusion criteria:
- •For the randomised trial, same as for screening, but in addition:
- •1. Major fetal abnormality
- •2. Women with established PE
- •3. Statin use within 28 days prior to randomisation
- •4. Women with contraindications for statin therapy:
- •4.1. Hypersensitivity to pravastatin or any component of the product
- •4.2. Lactose intolerance
- •4.3. Current or previous cancer
- •4.4. Previous solid organ transplant
- •4.5. Active liver disease (acute hepatitis, chronic active hepatitis) in the past 6 months
- •4.6. Chronic renal disease/insufficiency with baseline serum creatinine > 1.5mg/dL
- •4.7. History of myopathy or rhabdomyolysis
- •4.8. ALT and/or AST levels > = 2 x the upper limit of normal
- •4.9. Creatine kinase levels > = 5 x the upper limit of normal
- •4.10. Concurrent and chronic (> 6 months) use of medications with potential drug interactions with statins, such as immunosuppressive drugs, fibrates, gemfibrozil, niacin, protease inhibitors, efavirenz (non-nucleoside reverse transcriptase inhibitor), erythromycin, clarithromycin, itraconazole, cholestyramine, digoxin, rifampicin (patients will not be excluded if the drug has been discontinued, or is prescribed for a short duration of time)
- •5. Participating in another intervention study that influences the outcomes of this study
研究者
相似试验
已完成
不适用
StratCare TrialISRCTN11106183niversity of Sheffield951
已完成
4 期
Trial to evaluate the efficacy and safety of a combination of xyloglucan and gelose associated to oral rehydration salts for the treatment of acute diarrhea in childreDigestive SystemAcute diarrheaISRCTN61965252OVENTURE S.L.100
已完成
不适用
Journeying through dementia: exploring the clinical and cost-effectiveness of a group self-management intervention for people in the early stages of dementiaSpecialty: Dementias and neurodegeneration, Primary sub-specialty: DementiaUKCRC code/ Disease: Neurological/ Other disorders of the nervous systemMental and Behavioural DisordersDementiaISRCTN17993825Sheffield Health & Social Care NHS Foundation Trust519
已完成
不适用
Does a simple modification of the VAC therapy system reduce the daily treatment cost for wounds?Acute and chronic woundsInjury, Occupational Diseases, PoisoningAcute wound Chronic woundISRCTN15430640Department of Plastic & Reconstructive Surgery52
已完成
不适用
Cereal nutrition for child health trialISRCTN33260236St George's, University of London272