PravastatIn tO preveNt prEtErm biRth (PIONEER): a parallel group randomised placebo-controlled trial
Status: In set up
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: Participants may not enter the trial if ANY of the following apply:
- Multiple pregnancy
- Age <16 years
- Contraindication to Pravastatin
- Personal or first-degree relative with heritable muscle disorder
- Participating in the active phase of another interventional trial
- Lactose intolerance
- Alcohol intake >14 units a week
- Past or current liver disease, including obstetric cholestasis
- Creatine kinase concentration >5 times the upper limit of normal
Intervention/Control: Pregnant people will be randomly assigned to one of two groups:
- the Intervention group will take Pravastatin 20mg daily until 37 weeks gestation, or birth if earlier
- the Control group will take a placebo daily until 37 weeks gestation, or birth if earlier
Chief Investigator name: Dr Kate Birchenall
Trial Portfolio Leads: Maddie Clout / Caroline Pope
X Page: @PioneerTrial