A feasibility study investigating pravastatin for the prevention of preterm birth in wome
- Conditions
- Preterm BirthMedDRA version: 20.0Level: LLTClassification code 10032405Term: Other preterm infantsSystem Organ Class: 100000004868Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2017-005021-21-GB
- Lead Sponsor
- niversity of Edinburgh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 7
•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
••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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method