$1.19 million for rare liver disorder in pregnancy

The University of Adelaide will lead an international, multi-centre project to help find the best treatment for a rare pregnancy complication that can cause increased risk of preterm and still birth, and considerable distress.

The University has received a grant of $1.19 million – announced today by Health Minister, the Hon. Greg Hunt – from the Australian Government’s Medical Research Future Fund scheme.

“In pregnant women with severe early onset intrahepatic cholestasis of pregnancy (ICP), premature labour and delivery is often seen, and there’s a three-fold increased risk of fetal distress and stillbirth, as well other pregnancy complications including pre-eclampsia and gestational diabetes,” says project leader and chief investigator Professor William “Bill” Hague, of the University of Adelaide’s Robinson Research Institute and the Women’s and Children’s Health Network.

“Although the risk of stillbirth is increased in ICP, it is still very rare. Obstetricians have difficulty in predicting the stillbirths and will often deliver the baby prematurely just to avoid this small risk, but thereby increasing all the other risks associated with pre-term delivery.

“The associated itching that can occur can be extremely severe, leading to major skin damage from persistent, 24/7, profound and debilitating scratching, sometimes leading to very severe depression.”

ICP is a metabolic disease leading to increased concentration of potentially toxic “bile acids” in the blood associated with dysfunctional metabolism in the liver during pregnancy. While 0.7% of women may develop mild ICP towards the end of pregnancy, about one in every 1000 pregnant women develops a severe form of the disorder much earlier in pregnancy. The liver dysfunction can occasionally lead to jaundice in the mother.

“This is a prime example of how the University of Adelaide is leading the State in major national and international medical research projects that have a direct link to clinical outcomes,” says Professor Mike Brooks, Deputy Vice-Chancellor Research at the University of Adelaide.

“It follows closely behind the $23.2 million awarded in December and $8.3 million in October by the National Health and Medical Research Council for new projects tackling cancer, heart disease and other significant health problems. Congratulations to Professor Hague and colleagues for this most recent grant success.”

Treatment options for ICP are not well established and, although the disorder is recognised as often running in families, little is known about the genetics of the condition. There has also been very little study of the longer-term outcomes for affected children.

The multi-centre study will compare the clinical outcomes of two drugs – ursodeoxycholic acid (UDCA), which can help reduce the itching in pregnancy, as well as improve abnormal liver function, and rifampicin, which has been used for similar itching outside of pregnancy, but which, to date, has not formally been tested in ICP.

If rifampicin proves to be an effective agent in reducing adverse effects in ICP, either on its own or in combination with UDCA, it will then be possible to move to further trials to study the impact of the drugs in terms of pregnancy outcomes, in particular, on preterm birth and stillbirth. Initially there will be seven clinical sites across Australia and one each in the UK, The Netherlands and Sweden.