PITCHES: can UDCA help prevent stillbirth in women with liver disease?

Researchers supported by Tommy’s want to find out for certain if a drug can be used to protect babies against stillbirth and premature birth in women with a common liver disease.

ICP, or intrahepatic cholestasis of pregnancy, is the most common liver disease during pregnancy, and affects around 1 in 150 pregnancies. Symptoms include itching, and high levels of chemicals made by the liver – bile acids – in the blood.

Normally, bile acids travel to the gut, where they help you to digest food. In women with ICP, these acids stop flowing properly and instead build up in the body. A woman’s likelihood of developing the condition is related to her ethnicity, and can seem to run in families. While it can be dangerous during pregnancy, it disappears after birth.

Diagnosing ICP early in pregnancy is crucial. High levels of bile acids can increase the risks of the baby being stillborn, or born too early.

At the moment, the main drug used to treat ICP is ursodeoxycholic acid, or UDCA. We recently ran a small trial, which showed UDCA might help protect the babies of women with ICP. However, at the moment there is not enough evidence to be sure of the benefits of the drug. We are supporting a much larger study to try and find out if UDCA can protect babies by comparing women with ICP taking UDCA to women taking a placebo.

We think that UDCA will give babies a better chance of survival – but we want to be absolutely sure.

We will also collect blood samples from some mothers and babies to try and understand why ICP can cause premature birth or stillbirth. If we can understand this, we will have a better idea of how UDCA might prevent these from happening.

The trial will look at women in many different centres between 20 and 40 weeks of pregnancy. Women will randomly be chosen to take UDCA or a placebo. We will then monitor how many babies are stillborn, born too early, or are ill enough to be admitted to the neonatal unit in hospital.

At the moment, the trial is running in 29 different centres and includes 137 women. We expect to carry on recruiting until the middle of 2018 and aim to involve over 600 women. 

I have ICP and am interested in taking part in this trial

Researchers

Professor Lucy Chappell, Professor Catherine Williamson, Dr Carolyn Gill, Dr Caroline Ovadia, Dr Peter Dixon

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Funding

This study takes place in a Tommy's centre and is funded by Tommy's and the National Institute for Health Research

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