ISRCTN82984919已完成未知
A feasibility study investigating pravastatin for the prevention of preterm birth in women
The University of Edinburgh and/or Lothian Health Board0 个研究点目标入组 7 人开始时间: 2019年2月15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
- 7
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 participant inclusion criteria as of 17/06/2019:
- •1. Aged 16 years or above
- •2. Singleton pregnancy
- •3. Gestation =24+0 and =35+6 weeks (based on dating scan obtained at =16 weeks gestation)
- •4. Not previously recruited to this study in this pregnancy
- •5. Intact membranes
- •6. A positive fetal fibronectin test OR a short cervical length (=15 mm) on ultrasound examination OR cervical dilation =3 cm and less than fully dilated
- •7. Uterine activity defined as =1 palpable contraction over 20 minutes of CTG monitoring.
- •8. 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.
- •Previous participant inclusion criteria:
- •1. Aged 16 years or above
- •2. Singleton pregnancy
- •3. Gestation =28+0 and =35+6 weeks (based on dating scan obtained at =16 weeks gestation)
- •4. Not previously recruited to this study in this pregnancy
- •5. Intact membranes
- •6. A positive fetal fibronectin test OR a short cervical length (=15 mm) on ultrasound examination OR cervical dilation =3 cm and less than fully dilated
- •7. Uterine activity defined as =1 palpable contraction over 20 minutes of CTG monitoring.
- •8. 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.
排除标准
- •1. Immediate delivery deemed necessary for fetal or maternal reasons as determined by a senior clinician
- •2. Pre-labour, preterm rupture of membranes in the index pregnancy
- •3. Obstetric cholestasis as defined by RCOG (RCOG Green-Top Guideline, Number 43)
- •4. Established severe pre-eclampsia or HELLP syndrome as defined by NICE guidance (Hypertension in pregnancy: diagnosis and management | Guidance and guidelines | NICE n.d.)
- •5. Known history of hepatic or renal impairment
- •6. Ingestion of drugs thought to alter the pharmacokinetics or efficacy of statins, including erythromycin and/or nifedipine
- •7. Taking any one of the prohibited drugs as listed the SmPC and in 5.7.3
- •8. Lactose intolerance (due to excipient in pravastatin and placebo tablets)
- •9. Current or previous alcohol misuse
- •10. Personal or first degree relative with heritable muscle disorders
- •11. Participating in another CTIMP trial
研究者
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