Date: 29 August 2019
Recommended treatment for a common pregnancy liver disorder that can result in preterm birth and stillbirth is ineffective, according to new research funded by the NIHR.
Research midwives at West Middlesex University Hospital recruited 33 women to the PITCHES study, led by Kings College London.
The PITCHES study was carried out at 33 maternity units in England and Wales between December 2015 and September 2018. West Middlesex was the fourth highest recruiter.
The study looked at 605 pregnant women with intrahepatic cholestasis of pregnancy (ICP), 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 an 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 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.
Joanna Girling, Clinical Research Network North West London Divisional Lead at Chelsea and Westminster Hospital NHS Foundation Trust, said: “This was an exciting study to be part of, as it addressed a really important clinical question about management for women with intrahepatic cholestasis of pregnancy.”
“The result, that UDCA does not improve perinatal outcome, is changing clinical practice. So called negative results are sometimes seen as less valuable, but this is an important step forward for evidence based-medicine. It also helps to enlighten anyone who still thinks that drug trials can’t be performed in pregnancy.”
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.