ISRCTN23410175已完成4 期
A proof of principle, double-blind, randomised placebo-controlled, multicentre trial of pravastatin to ameliorate early onset pre-eclampsia
niversity College London Hospitals NHS Foundation Trust (UK)0 个研究点目标入组 62 人开始时间: 2009年5月8日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
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
- •Current inclusion criteria as of 27/09/2010:
- •To be eligible for the StAmP Trial, the women must:
- •1. Be between 24+0 weeks' and 31+6 weeks' gestation
- •2. Have a singleton pregnancy
- •3. Have a diagnosis of early onset pre-eclampsia
- •4. Be considered capable of safely continuing the pregnancy for 48 hours or more, as determined by the attending clinician
- •5. Obstetrician and neonatologist believe the fetus is likely to be viable
- •6. No major anomalies evident on the 20-week anomaly scan. Any anomaly should be assessed by the Principal Investigator and discussed with the Chief Clinical Investigator, following classification of the anomaly according to the ICD-10 codes. All major anomalies will be excluded, but minor anomalies, subject to agreement between the PI and CI will be included
- •7. Be capable of understanding the information provided, with use of an interpreter if required
- •8. Give written informed consent
- •Previous inclusion criteria:
- •To be eligible for the StAmP Trial, the women must:
- •1. Be at least 24 weeks and less than 33 weeks' gestation (no age limits on participant)
- •2. Have a diagnosis of pre-eclampsia
- •3. Have a normal cardiotocograph
- •4. Be considered capable of safely continuing the pregnancy for 12 hours or more
- •5. Be capable of understanding the information provided, with use of interpreter if required
- •6. Give written informed consent
排除标准
- •Current exclusion criteria as of 27/09/2010:
- •Any women, who at the point of randomisation, exhibit any of the following are not eligible for the trial:
- •1. Eclampsia
- •2. Current use of statins
- •3. Contraindications to statin use (other than pregnancy) including:
- •3.1. Hypersensitivity to pravastatin or any of its excipients
- •3.2. Active liver disease or elevation of serum transaminases not thought to be related to pre-eclampsia
- •3.3. Pre-pregnant renal insufficiency (creatine clearance less than 30 ml/min)
- •3.4. Concomitant administration of potent CYP3A4 inhibitors
- •4. Imminent transfer to a non-trial centre due to unavailability of neonatal cots
- •5. Participation in any other blinded, placebo-controlled trials of investigational medicinal products in pregnancy
- •6. Significant uncertainty regarding gestational age. Under 24 weeks' gestation, pregnancies are often not considered viable and therefore women with pre-eclampsia less than 24 weeks gestation will be excluded. Women with pre-eclampsia around 32 weeks' gestation are often delivered when the mother is stable and therefore we will exclude women who develop pre-eclampsia over 32 weeks' gestation. For this reason, if there is any uncertainty about the gestational age, the mother should not be approached for randomisation.
- •Previous exclusion criteria:
- •Any women, who at the point of randomisation, exhibits any of the following symptoms or contraindications, are not eligible for the trial:
- •1. Eclampsia
- •2. Absent or reversed end-diastolic flow
- •3. Pre-pregnant or continuing use of statins
- •4. Contraindications to statin use (other than pregnancy)
研究者
相似试验
已完成
2 期
A study to evaluate if CD388 can prevent infection with flu virus and to assess the safety, tolerability, absorption, distribution and excretion of CD388 in healthy adultsRespiratoryInfluenza and pneumoniaInfluenzaISRCTN14841526hVIVO Limited Services59
进行中（未招募）
1 期
A Proof of Principle, Double-Blind, Randomised Placebo-Controlled,Multi-centre Trial of pravaStatin to Ameliorate Early Onset Pre-eclampsia - StAmPPre-eclampsiaEUCTR2009-012968-13-GBniversity College London62
进行中（未招募）
1 期
A Proof of Principle, Double-Blind, Randomised Placebo-Controlled,Multi-centre Trial of pravaStatin to Ameliorate Early Onset Pre-eclampsia - StAmPPre-eclampsiaEUCTR2010-023502-12-GBniversity College London
进行中（未招募）
1 期
An efficacy and safety study of STR-324 in post-operative paiEUCTR2019-003019-80-NLStragen France116
招募中
2 期
A proof of concept randomized, double-blind, parallel group, controlled dose-finding and safety study of STR-324 in post-operative paiNL-OMON54385ALAXIA SAS118