Status: Open to recruitment
Sponsor: University Hospitals Bristol and Weston NHS Foundation Trust
Aim: PIONEER aims to investigate whether taking the medication Pravastatin reduces the number of babies born too early (preterm i.e., before 37 weeks of pregnancy), in pregnant people who are at medium to high risk of preterm birth. The trial also aims to understand how Pravastatin prevents preterm birth.
Design: Multicentre, parallel group, placebo-controlled, randomised controlled trial with blinding and an internal pilot phase. There will be an embedded mechanistic investigation and integrated Qualitative Recruitment Intervention to optimise recruitment and adherence.
Overall participant target: 750 pregnant people over three years.
Project Timeline: Trial duration 60 months: 8-months set up, 36-months recruitment (12-months internal pilot, 24-months main trial), 8-months follow up, 8-month analysis and reporting.
Inclusion Criteria: Pregnant people with a singleton pregnancy at high or intermediate risk for preterm birth AND between 16-20 weeks gestation at randomisation.
Exclusion Criteria:
- Multiple pregnancy.
- <16 years of age.
- Hypersensitivity to Pravastatin (active substance or any of the excipients).
- Personal or first-degree relative with heritable muscle disorder.
- Participating in the active phase of another CTIMP.
- Lactose intolerance.
- >14 units alcohol/week.
- Past/current liver disease.
- ALT or AST above upper limit of normal (as set by local laboratories), to be taken at the time of screening.*
- Bilirubin above upper limit of normal (as set by local laboratories), to be taken at the time of screening.*
- Creatine Kinase (CK) concentration >5 times upper limit of normal (as set by local laboratories), to be taken at the time of screening.
- Currently breastfeeding.
- Unable to provide informed consent.
- Previously participated in PIONEER.
- Currently taking medicines or groups of medicines that are contraindicated for concomitant use with pravastatin§
* It is acknowledged that the Liver Function Test may include different assessments at different sites, therefore for the purpose of the screening blood test, the term “Liver Function Test” at screening should include measurement of Bilirubin and at least one of ALT or AST. If any of these are above the upper limit of the normal, the person would not be eligible for inclusion in PIONEER, and should have ongoing follow-up according to local policy.
§ Those taking macrolides should be excluded from PIONEER, however, if a limited course of macrolides are prescribed with the course due to complete prior to 20+0 weeks’ gestation, then it may be possible to recruit to PIONEER following completion of the course of antibiotics (if completion of the course of antibiotics is prior to 20+0).
Contact Information
Chief Investigator name: Dr Kate Birchenall
Trial Portfolio Leads: Maddie Clout / Caroline Pope
Email: pioneer-trial@bristol.ac.uk
X Page: @PioneerTrial
Information videos about the trial
PIONEER Information Video for Non-Mechanistic study sites
PIONEER Information Video for Mechanistic study sites
