PIPIN
Research type
Research Study
Full title
A feasibility study investigating pravastatin for the prevention of preterm birth in women
IRAS ID
234899
Contact name
Jane E. Norman
Contact email
Eudract number
2017-005021-21
Clinicaltrials.gov Identifier
N/A
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
A Feasibility Study Investigating Pravastatin for the Prevention of Preterm Birth in Women: PIPIN
PIPIN is a randomised controlled trial to see whether women who come to hospital with signs and symptoms of labour before 36 weeks gestation would be willing to take a medication (Pravastatin) or placebo treatment. Preterm (<37 weeks gestation) birth is estimated to leave one million children a year with neurodevelopmental disability, and current treatments have only a marginal effect on timing of delivery with little protection against brain injury. Whilst the survival of babies born preterm in the UK has improved in the last 20 years, the proportion of survivors without neurodevelopmental disability has remained static. As evidence implicates the inflammatory environment associated with preterm labour and delivery with foetal brain damage, it follows that medications with known anti-inflammatory properties may abrogate this injury. Statins have been shown not only to have wide-ranging anti-inflammatory properties, but also to reduce contraction frequency and time to delivery in preclinical studies. Pravastatin, one of these medications, has a published safety profile in pregnancy, and other trials have observed pregnancy-prolonging effects. We will recruit women who come to hospital with preterm labour, and will ask them to take one tablet a day for 7 days. During this time, we will monitor their contractions, markers of inflammation in both the maternal and foetal blood (from the umbilical cord), and how long after presentation they deliver their baby. After delivery, we will collect data from both mothers and babies for a core outcome set, and ask participants about their experience of being involved in the trial. This will be a single site study of 2 years. Participants themselves will be involved from presentation to estimated delivery date + 28 days, with a maximum treatment period of 7 days.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
18/ES/0007
Date of REC Opinion
26 Mar 2018
REC opinion
Further Information Favourable Opinion