Intrahepatic cholestasis of pregnancy – Diagnosis and management: A consensus statement of the Society of Obstetric Medicine of Australia and New Zealand (SOMANZ): Executive summary

Abstract

KEY POINTS Intrahepatic cholestasis of pregnancy (ICP) is a pregnancy liver disease, characterised by pruritus and increased total serum bile acids (TSBA), Australian incidence 0.6–0.7%. ICP is diagnosed by non‐fasting TSBA ≥19 μmol/L in a pregnant woman with pruritus without rash without a known pre‐existing liver disorder. Peak TSBA ≥40 and ≥100 μmol/L identify severe and very severe disease respectively, associated with spontaneous preterm birth when severe, and with stillbirth, when very severe. Benefit‐vs‐risk for iatrogenic preterm birth in ICP remains uncertain. Ursodeoxycholic acid remains the best pharmacotherapy preterm, improving perinatal outcome and reducing pruritus, although it has not been shown to reduce stillbirth.

Clinical Management Guidelines for Intrahepatic Cholestasis of Pregnancy

“…Thus, TBA ≥19 μmol/L could be used as a diagnostic threshold to improve the accuracy of ICP diagnosis. 34 Based on these findings, the RCOG 2022 ICP guidelines 25 and the 2023 Society of Obstetric Medicine Australia and New Zealand (SOMANZ) expert consensus 35 both use a TBA concentration ≥19 μmol/L as the ICP diagnostic standard. Therefore, based on existing evidence, this consensus recommends fasting serum TBA level ≥10 μmol/ L or postprandial serum TBA ≥19 μmol/L as the diagnostic criteria for ICP.…”

“…Intrahepatic cholestasis of pregnancy should exclude hepatitis virus, Epstein-Barr virus, and cytomegalovirus infection, and routine ultrasonography is recommended to rule out hepatobiliary surgery in pregnant women. 15,25,35 Recommendation 4-1 Unexplained pruritus during pregnancy should prompt consideration of ICP (strong recommendation, high level of evidence).…”

“…23,24 Hence, to emphasize clinical awareness and management during pregnancy, this guideline recommends defining serum TBA level ≥100 μmol/L as the diagnostic threshold for extremely severe ICP, referring to the latest international ICP guidelines and expert consensus. 15,25,35 Outcomes for perinates in early-onset ICP are worse, so it is recommended to manage it as severe ICP. 37 However, there is currently no universal standard for the diagnosis of early-onset ICP owing to varying gestational weeks in various studies involving early-onset ICP.…”

“…45,46 Therefore, current RCOG, SMFM, and SOMANZ consensus all agree that fetal monitoring cannot reduce the occurrence of stillbirths and do not recommend continuous in utero monitoring, unless there is a reduction in fetal movement, 25 abnormal fetal monitoring possibly leading to pregnancy termination, 15 or other pregnancy complication indicators. 35 What frequency of monitoring is suitable remains unclear because of the lack of ample evidence. 14,15 This guide still recommends monitoring in utero conditions based on fetal movement, electronic fetal monitoring, and ultrasound examinations.…”

“…While an elevated serum TBA level is the earliest biochemical abnormality in 90% of ICP cases, serum aminotransferase is also commonly used as a biochemical reference marker in clinical diagnosis. Although its sensitivity is not as high as TBA, the 2020 SMFM guidelines, 15 the 2022 RCOG guidelines, 25 and the 2023 SOMANZ expert consensus 35 recommend conducting serum aminotransferase tests, especially when patients present with weight loss, poor appetite, jaundice, discomfort, and upper abdominal pain. However, serum aminotransferase is not a necessary criterion for diagnosing ICP 36 .…”