Treatment for liver disorder in pregnancy ineffective, finds new study
Recommended treatment for a common pregnancy liver disorder that can result in preterm birth and stillbirth is ineffective, according to new research funded by NIHR.
Researchers at King’s College London carried out the PITCHES trial at 33 hospital maternity units in England and Wales between December 2015 and September 2018. 605 pregnant women with intrahepatic cholestasis of pregnancy (ICP) were recruited with half receiving ursodeoxycholic acid (known as ‘urso’), the current drug used to treat the condition, and half a placebo.
ICP is a liver disorder affecting approximately 5,500 pregnancies annually in the UK. The condition causes build-up of bile acids in the blood, and symptoms include itching, often severe. An increase in bile acid is associated with increased risk of stillbirth, preterm birth, and neonatal unit admission.
The researchers collected blood tests and samples, measured the women’s level of itching and recorded birth information.
Results today published in the Lancet found that urso did not have an impact on pregnancy outcomes including preterm birth, neonatal unit admission and stillbirth. They also found that it did not show any meaningful improvement in itch for most women, nor did it reduce the woman’s bile acid levels.
Before now, urso hasn’t been tested in any large clinical trials to show whether it prevents premature birth and stillbirth.
Lead author Professor Lucy Chappell, 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 research was funded by the Efficacy and Mechanism Evaluation (EME) Programme – a Medical Research Council (MRC) and National Institute for Health Research (NIHR) partnership - and was supported by the NIHR Clinical Research Network (CRN). It builds on an earlier study which identified a simple bile acid blood test that could tell risk of stillbirth.
Scientists are now looking to identify other potential treatments for women with ICP. 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 blood stream.
More information on the study is available on the NIHR Journals Library.