Recommended treatment for a common pregnancy liver disorder that can result in preterm birth and stillbirth was found ineffective, according to a recent research published in The Lancet.
Researchers from King’s College London investigated upon the efficiency of ursodeoxycholic acid, a commonly recommended drug for pregnant women suffering from intrahepatic cholestasis of pregnancy (ICP).
ICP is a common pregnancy liver disorder that causes build-up of bile acids in the blood, and may result in symptoms include itching. An increase in bile acid is associated with a heightened risk of stillbirth, preterm birth, and neonatal unit admission.
The trial (PITCHES) was carried out by a team of scientists at 33 hospital maternity units in England and Wales between December 2015 and September 2018. They recruited 605 pregnant women with ICP with half receiving ursodeoxycholic acid, and half with a placebo.
The researchers collected blood tests and samples, measured the women’s level of itching and recorded birth information.
The trial reported that ursodeoxycholic acid did not have an impact on pregnancy outcomes including preterm birth, neonatal unit admission and stillbirth. The researchers 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.
“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 Professor Lucy Chappell, Department of Women & Children’s Health at King’s College London, in a news release.
“It is now clear that ursodeoxycholic acid 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 Professor Catherine Williamson, Department of Women & Children’s Health at King’s College London and co-investigator of the PITCHES trial.
Scientists are now looking to identify other potential treatments for women with ICP. A clinical drug trial using rifampicin, will be starting in early 2020, reports said.