Drug used for liver disorder in pregnancy found to be ineffective

A drug used to treat liver disorder in pregnant women is ineffective and should not be used routinely, scientists have said.

Intrahepatic cholestasis of pregnancy (ICP) affects around 5,500 pregnancies a year in the UK and symptoms include severe itching.

The condition causes build-up of bile acids in the blood, which is associated with increased risk of premature or stillborn babies.

Research led by Kings College London found that women treated with ursodeoxycholic acid (urso) did not experience a “meaningful” improvement in itching or reduced bile acid levels.

The drug also had no significant impact on the number of neonatal unit admissions, premature births or stillborn babies, the authors said.

Lead author Professor Lucy Chappell, of the Department of Women & Children’s Health at King’s College London said: “We want to find a safe and effective treatment for women with cholestasis of pregnancy, so that we can prevent stillbirths in this condition.

“This trial has shown that the widely used drug ursodeoxycholic acid is not the answer. It is essential that we share these findings with pregnant women and clinicians so that we can avoid unnecessary medication in pregnancy.

“We now need to focus on finding a treatment that does work.”

The trial took place at 33 hospital maternity units in England and Wales between December 2015 and September 2018.

Some 605 women with ICP took part, around half of whom received urso and half of whom were given a placebo.

Jenny Chambers, CEO of ICP Support, said: “As a charity we witness the anxiety that many women with ICP experience because the fear of stillbirth is uppermost in their minds; effective drug treatments are therefore vital to help reduce this fear.

“The trial clearly demonstrates that for most women urso is not the drug to do this and while the outcome is likely to be hugely disappointing for women, it is also vital that they are not being falsely reassured.”

Professor Catherine Williamson, also of the Department of Women & Children’s Health at King’s College London, added: “It is now clear that urso should not be used routinely to treat all women with ICP.

“Our future research focus will be to try to establish whether there is a subgroup of women who may still benefit from this drug, and also to focus on new drugs to improve outcomes for mothers and babies of ICP pregnancies,”