Pravastatin tO preveNt prEtErm biRth (PIONEER)
Research type
Research Study
Full title
PravastatIn tO preveNt prEtErm biRth (PIONEER): a parallel group randomised placebo-controlled trial
IRAS ID
1007563
Contact name
Katherine Birchenall
Contact email
Sponsor organisation
University Hospitals Bristol and Weston NHS Foundation Trust
ISRCTN Number
ISRCTN93398587
Research summary
Around 7 out of every 100 UK babies are born too early (preterm, i.e., before 37 weeks of pregnancy). Being born preterm is the most common cause of babies dying before the age of one year in the UK; 1 in 3 of those who survive are diagnosed with cerebral palsy. We will test whether the medicine Pravastatin reduces the number of babies born preterm and therefore reduces the number of babies who die or have life-long conditions. We do not fully understand why some babies are born early, and there are few effective treatments to prevent this from happening. Research shows it is likely that early labour may occur because of types of inflammation in the mother’s body. Taking a medication which reduces inflammation, such as Pravastatin, could therefore reduce the number of babies being born preterm. Pravastatin has been tested for the treatment and prevention of other pregnancy problems, with no safety concerns for women or their babies, and some studies suggest that it may reduce the numbers of babies born preterm. This study will test whether taking one tablet of Pravastatin once a day, from between 16-20 weeks of pregnancy until 37 weeks, reduces the number of babies born too early. We will ask women who attend Preterm Birth Prevention clinics if they would like to join the study. If they join, half will be given Pravastatin and half will be given a placebo (a dummy tablet which looks like Pravastatin but does not contain Pravastatin). Neither the women nor the researchers will know which tablets they are taking until the end of the study. We will record at how many weeks of pregnancy their babies are born and compare this between the two groups of women. We will also measure levels of certain bacteria and markers of inflammation, which are related to babies being born early, by collecting blood, fluid produced in the vagina and stool samples. We will record any complications the women or their babies have and look at the babies’ development at two years of age.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
24/NW/0074
Date of REC Opinion
17 Apr 2024
REC opinion
Further Information Favourable Opinion