This project took place at our Edinburgh centre which operated between 2008 and 2021.
Why do we need this research?
Premature birth can cause health problems for babies and is the leading cause of death in children under five years old. However, when a mother goes into labour too early, the treatments that are currently used to delay birth or prevent health problems for the baby aren’t always effective. We need to find better treatments for women in preterm labour in order to give premature babies the best possible start in life.
What happened in this project?
Researchers funded by Tommy’s previously carried out lab experiments that showed that drugs normally used to prevent heart disease may also delay premature birth. These drugs, called statins, work by reducing inflammation, which causes health problems for both mother and baby during and after preterm labour. Statins also appear to reduce the contractions of the muscle cells that line the womb. One drug, called pravastatin, has been shown to be safe during pregnancy, and early trials indicate that it may also delay birth.
Before planning a large-scale trial of pravastatin, our researchers wanted to carry out a small study – called PIPIN – to see if it is feasible to give pravastatin to women in preterm labour. The team planned on recruiting 40 women who had signs and symptoms of preterm birth, with the women receiving either pravastatin or a placebo tablet for seven days or until they delivered (whichever was shortest). Unfortunately, the trial had to be stopped after 15 months due to poor recruitment – only 18 women were spoken to about the trial, and of these, seven agreed to take part. The PIPIN study has therefore shown that it is challenging to recruit women who are already in preterm labour into a clinical trial, and that drugs like pravastatin need to be tested in different ways in the future.
While it was not possible to test whether pravastatin prevents premature labour, the researchers did show that pravastatin was not present in blood from the umbilical cord at birth, even when levels were high in the mother.
What difference will this project make?
The PIPIN study has shown that it is not possible to recruit women who are already in preterm labour into a clinical trial of pravastatin. In order to test how effective pravastatin is at delaying labour, an alternative trial design is needed. One possibility is that women who are at high risk of premature birth are asked to start taking pravastatin earlier in pregnancy, before labour begins. Our hope is that further clinical studies can now be performed, ultimately leading to the development of a new treatment that prevents premature birth and reduces the chances of health problems for babies.
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