EUCTR2017-005021-21-GB进行中（未招募）1 期
A feasibility study investigating pravastatin for the prevention of preterm birth in women - PIPI
niversity of Edinburgh0 个研究点目标入组 7 人开始时间: 2018年8月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 7
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Gestation between 28+0 and 35+6 weeks inclusive (based on dating scan obtained at = 16 weeks gestation)
- •Singleton pregnancy
- •Aged 16 years or above
- •Not previously recruited to this study in this pregnancy
- •Intact membranes
- •A positive fetal fibronectin test OR a short cervical length (? 15mm) on ultrasound examination OR cervical dilation = 3cm and less than fully dilated
- •Uterine activity defined as = 1 palpable contraction over 20 minutes of CTG monitoring.
- •No major congenital anomalies evident on the 20 week anomaly scan, or any further anomaly scans performed subsequently. If an anomaly is present, this should be classified as per ICD-10 codes and minor anomalies discussed for inclusion on a case by case approach involving the clinical team, the PI and the participant.
- •Not demonstrating any of the exclusion criteria
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 3
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 37
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- ••Immediate delivery deemed necessary for fetal or maternal reasons as determined by a senior clinician.
- •Pre-labour, preterm rupture of membranes in the index pregnancy
- •Obstetric Cholestasis as defined by RCOG (RCOG Green-Top Guideline, Number 43)
- •Established severe pre-eclampsia or HELLP syndrome as defined by NICE guidance (Hypertension in pregnancy: diagnosis and management | Guidance and guidelines | NICE n.d.)
- •Known History of hepatic or renal impairment
- •Ingestion of drugs thought to alter the pharmacokinetics or efficacy of statins, including erythromycin and/or nifedipine.
- •Taking any one of the prohibited drugs as listed the SmPC and in 5.7.3
- •Lactose intolerance (due to excipient in Pravastatin and placebo)
- •Current or previous alcohol misuse
- •Personal or first degree relative with heritable muscle disorders
- •Participating in another CTIMP trial
研究者
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