Treatment for liver disorder during pregnancy ineffective: Experts

A recent study found that the currently recommended treatment for a common pregnancy liver disorder that can result in preterm birth and still birth is ineffective and should be reconsidered.

In a paper published, it was found that 605 pregnant women with intrahepatic cholestasis of pregnancy (ICP), a liver disorder, were recruited with half receiving ursodeoxycholic acid (known as ‘urso’), the current drug used to treat the condition, and half a placebo. The researchers collected blood tests and samples, measured the women’s level of itching and recorded birth information.

The authors discovered that urso did not have an impact on pregnancy outcomes including preterm birth, neonatal unit admission, and stillbirth. They also got to know that it did not show any meaningful improvement in itch for most women, nor did it reduce the woman’s bile acid levels.
Intrahepatic cholestasis of pregnancy (ICP) is a liver disorder affecting approximately 5,500 pregnancies annually in the UK. The condition causes the build-up of bile acids in the blood, and symptoms include itching, often severe. An increase in bile acid is associated with an increased risk of stillbirth, preterm birth, and neonatal unit admission.

Until now, urso hasn’t been tested in any large clinical trials to show whether it prevents premature birth and stillbirth.

“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,” said the lead author of the study.

“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. What we now urgently need is a drug treatment that can reduce both the itch and the risk of stillbirth that is associated with the condition and ICP Support will continue to work with researchers in their fight to do this,” said a researcher involved in the study.

Scientists are now looking to identify other potential treatments for women with this liver disorder. A clinical drug trial will be starting in early 2020 using rifampicin, an antibiotic that is also an effective treatment for itch outside pregnancy and improves removal of bile acids from the bloodstream.

“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,” added co-investigator of the study.

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Giving diabetic women an artificial pancreas could prevent stillbirths and save thousands of lives

Pregnant women have been given an ‘artificial pancreas’ for the first time, in a breakthrough experts hope will save the lives of thousands of babies.

Sixteen British women with type 1 diabetes gave birth to healthy infants during the Cambridge University-led trial.

They are the first women in the world to go through pregnancy with the devices, which use a tablet computer to automatically regulate their insulin levels.

This puts their unborn babies at risk of a number of complications, including premature birth, obesity and even stillbirth.

Half of all babies born to mothers with type 1 diabetes have some form of complication, research suggests.

Stillbirths affect very few of these - less than two per cent of all births - but that rate is about five times higher than it is among healthy mothers.

Some 400,000 people in the UK have type 1 diabetes, an autoimmune disease which means the body cannot produce its own insulin, stopping proper regulation of blood sugar.

It usually first strikes in childhood or adolescence, and unlike type 2 diabetes, is not caused by lifestyle or diet.

People with the condition usually have to inject themselves with insulin several times a day, carefully monitoring their blood sugar levels with finger prick tests.

The artificial pancreas enables this whole process is done automatically.

Scientists found a way to combine two existing devices – pumps which deliver insulin and glucose monitors – into a simple system controlled by a tablet computer.

Blood sugar is continuously monitored by a small sensor inserted beneath the skin of the tummy, this information is sent to a tablet computer, which calculates the right amount of insulin required, and this is pumped into the blood stream via a small machine worn on the belt.

The Cambridge trial, funded by Diabetes UK and the Government’s National Institute of Health Research, found the devices improved women’s control of their blood sugar by 25 per cent.

The results, published in the New England Journal of Medicine, need to be repeated in larger trials, but experts hope
the artificial pancreas could be available on the NHS within two years.

Dr Zoe Stewart, the lead author on the study, said: ‘Managing Type 1 diabetes in pregnancy can be really difficult.

‘Hormonal changes that occur in pregnancy make it difficult to predict the best insulin doses for each woman.

‘The artificial pancreas automates the insulin delivery giving better glucose control than we can achieve with current available treatments.

‘We are so pleased this technology is closer to being a reality for women with type 1 diabetes that want to have a child.’

The devices have previously been trialled on children and adults, but this is the first time that pregnant women - considered a much more risky group - have been able to use the gadgets.

Dr Elizabeth Robertson, director of research at Diabetes UK, said: ‘Artificial pancreas technology has the potential to transform the treatment of Type 1 diabetes, and could be particularly pivotal for women during pregnancy who often struggle with managing their blood glucose levels.

‘This study represents a real breakthrough in helping women to take control of their condition, and we’re very excited about the direction this research is moving.’

She added: ‘Diabetes UK have been investing in the development of the artificial pancreas since 1977 when we bought the first machine in the UK – which was the size of a filing cabinet.

‘Now we’re watching people use tablets or mobile phones, and it’s an incredible achievement.’ 

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