Preterm Birth MedDRA version: 20.0 Level: LLT Classification code 10032405 Term: Other preterm infants System Organ Class: 100000004868
Conditions
Interventions
Trade Name: Pravastatin Sodium
Product Name: Pravastatin Sodium
Pharmaceutical Form: Tablet
INN or Proposed INN: Pravastatin Sodium
CAS Number: 81093-37-0
Concentration unit: mg milligram(s)
Concentra
Sponsors
University of Edinburgh
NHS Lothian
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study is testing whether women between 28+0 and 35+6 weeks pregnant who come to hospital with signs and/or symptoms of preterm labour would be willing to take a medication (pravastatin) or placebo in a blinded fashion for 7 days. ;Secondary Objective: 1)To see if pravastatin when compared to placebo is associated with a longer time to delivery, fewer contractions, and lower markers of inflammation in both the mother and fetus in women with preterm labour. 2)To see if pravastatin when compared to placebo improves outcomes for both mother and baby. 3)To monitor the average time from when a participant is first established as eligible for the trial to when they get the first dose of study drug. 4)To establish how acceptable the study is to participants after completing the protocol. 5)To measure compliance with treatment. 6)To establish whether the blood concentrations of study drug in this population are the same as currently published data. ;Primary end point(s): Recruitment, retention and outcome collection of 40 Participants in established preterm labour. ;Timepoint(s) of evaluation of this end point: Recruitment of participant number 40 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Retention, adherence and ability to collect clinical outcomes from participants 2) Time to delivery from presentation and gestation at delivery 3) Contraction frequency from presentation to delivery or cessation of regular uterine activity. 4) Maternal markers of inflammation including, but not limited to: IL-6, IL-10, IL-13, IL-17, TNFa, IL-1RA, sTNF-RI,sTNF-R2, and HO-1, as well as levels of the soluble IL-6R and the inhibitor spg130 (abbreviated hereafter to ‘Inflammatory Profile’) 5) Fetal measures of inflammation (cord IL-1, IL-6, IL-8) as well as levels of sIL-6R and sgp130. 6) Adverse events (maternal and fetal) 7) Time from ‘time first seen’ to delivery of first dose of trial medication 8) Compliance with 7 days of blinded treatment 9) Acceptability of the trial to those who have participated 10) Pharmacokinetic parameters as compared with current published data 11) Maternal outcomes: a. Proven maternal infection b. Safety of intervention to mother (self-reported AEs and biochemical monitoring of liver function tests and creatinine kinase). c. Pre-labour ROM d. Duration, location and level of care of hospital stay following presentation with suspected preterm labour AND following delivery. 12) Neonatal outcomes: a. Neonatal morbidity (a composite measure of neonatal outcomes, including neurological, respiratory, gastrointestinal and cardiological measures, gestation and weight at birth, place and length of stay following delivery, evidence of sepsis and feeding type.) b. Neonatal mortality c. Safety of intervention;Timepoint(s) of evaluation of this end point: At estimated date of delivery + 28 days for the last participant recruited | — |
Countries
United Kingdom
Contacts
Public ContactSonia Whyte
University of Edinburgh
Outcome results
None listed