ICP should be diagnosed in pregnant women with pruritus and raised serum bile acid concentrations in the absence of other causes, such as pre-existing liver disease.[14]Girling J, Knight CL, Chappell L, et al. Intrahepatic cholestasis of pregnancy: green-top guideline no. 43 June 2022. BJOG. 2022 Aug 9 [Epub ahead of print].
https://obgyn.onlinelibrary.wiley.com/doi/10.1111/1471-0528.17206
http://www.ncbi.nlm.nih.gov/pubmed/35942656?tool=bestpractice.com
[76]Society for Maternal-Fetal Medicine; Lee RH, Greenberg M, Metz TD, et al. Society for Maternal-Fetal Medicine consult series #53: Intrahepatic cholestasis of pregnancy: replaces consult #13, April 2011. Am J Obstet Gynecol. 2021 Feb;224(2):B2-9.
https://www.ajog.org/article/S0002-9378(20)31284-9/fulltext
http://www.ncbi.nlm.nih.gov/pubmed/33197417?tool=bestpractice.com
Affected women often have associated liver dysfunction; most have elevated liver transaminase levels and a small proportion have raised bilirubin levels.[10]Conti-Ramsden F, McEwan M, Hill R, et al. Detection of additional abnormalities or co-morbidities in women with suspected intrahepatic cholestasis of pregnancy. Obstet Med. 2020 Dec;13(4):185-91.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7726172
http://www.ncbi.nlm.nih.gov/pubmed/33343695?tool=bestpractice.com
Itch often commences prior to elevations of serum biochemistry, hence repeated testing should be performed in women who remain symptomatic.[6]Kenyon AP, Tribe RM, Nelson-Piercy C, et al. Pruritus in pregnancy: a study of anatomical distribution and prevalence in relation to the development of obstetric cholestasis. Obstet Med. 2010 Mar;3(1):25-9.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4989767
http://www.ncbi.nlm.nih.gov/pubmed/27582836?tool=bestpractice.com
[9]Kenyon AP, Piercy CN, Girling J, et al. Pruritus may precede abnormal liver function tests in pregnant women with obstetric cholestasis: a longitudinal analysis. BJOG. 2001 Nov;108(11):1190-2.
http://www.ncbi.nlm.nih.gov/pubmed/11762661?tool=bestpractice.com
Internationally, the limited availability of rapid bile acid testing has led to hypercholanaemia (raised serum bile acid concentrations) not always being used for diagnosis. However, the clear association of adverse perinatal outcomes with bile acid concentrations, and not with other markers of liver dysfunction, highlights the importance of this test for diagnosis of ICP.[2]Ovadia C, Seed PT, Sklavounos A, et al. Association of adverse perinatal outcomes of intrahepatic cholestasis of pregnancy with biochemical markers: results of aggregate and individual patient data meta-analyses. Lancet. 2019 Mar 2;393(10174):899-909.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6396441
http://www.ncbi.nlm.nih.gov/pubmed/30773280?tool=bestpractice.com
Indeed, up to 20% of women with ICP do not have elevated liver transaminase levels.[10]Conti-Ramsden F, McEwan M, Hill R, et al. Detection of additional abnormalities or co-morbidities in women with suspected intrahepatic cholestasis of pregnancy. Obstet Med. 2020 Dec;13(4):185-91.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7726172
http://www.ncbi.nlm.nih.gov/pubmed/33343695?tool=bestpractice.com
History
Although the maternal itch of ICP is classically described to occur on the palms of the hands and soles of the feet, pruritus can occur at any site, including all over the body.[6]Kenyon AP, Tribe RM, Nelson-Piercy C, et al. Pruritus in pregnancy: a study of anatomical distribution and prevalence in relation to the development of obstetric cholestasis. Obstet Med. 2010 Mar;3(1):25-9.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4989767
http://www.ncbi.nlm.nih.gov/pubmed/27582836?tool=bestpractice.com
Typically, the itch is most severe at night, and this can result in severe sleep disturbance.[8]Steele G. Reflection on a pregnancy complicated by obstetric cholestasis. Pract Midwife. 2012 Oct;15(9):30-2.
http://www.ncbi.nlm.nih.gov/pubmed/23252070?tool=bestpractice.com
Women often report associated fatigue. Right upper quadrant abdominal pain is not infrequent and this may be associated with underlying cholelithiasis.[16]Kenyon AP, Piercy CN, Girling J, et al. Obstetric cholestasis, outcome with active management: a series of 70 cases. BJOG. 2002 Mar;109(3):282-8.
http://www.ncbi.nlm.nih.gov/pubmed/11950183?tool=bestpractice.com
Women commonly report dark urine and may have pale stools.[11]Tuson A, Chambers J. Top 10 things to know about intrahepatic cholestasis of pregnancy (ICP). Essentially MIDIRS. 2013 Nov;4(10):27-30.
https://www.icpsupport.org/pdf/MIDIRS_2013.pdf
Although the majority of women have symptoms beginning in the late second and third trimesters, ICP has been reported from early in the first trimester; early-onset persistent disease is likely to be more severe.[3]Stulic M, Culafic D, Boricic I, et al. Intrahepatic cholestasis of pregnancy: a case study of the rare onset in the first trimester. Medicina (Kaunas). 2019 Aug 9;55(8):454.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6723234
http://www.ncbi.nlm.nih.gov/pubmed/31404990?tool=bestpractice.com
[4]Lin J, Gu W, Hou Y. Diagnosis and prognosis of early-onset intrahepatic cholestasis of pregnancy: a prospective study. J Matern Fetal Neonatal Med. 2019 Mar;32(6):997-1003.
http://www.ncbi.nlm.nih.gov/pubmed/29065754?tool=bestpractice.com
[77]Estiú MC, Frailuna MA, Otero C, et al. Relationship between early onset severe intrahepatic cholestasis of pregnancy and higher risk of meconium-stained fluid. PLoS One. 2017 Apr 24;12(4):e0176504.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5402936
http://www.ncbi.nlm.nih.gov/pubmed/28437442?tool=bestpractice.com
The past medical history may include previous occurrence of ICP, pruritus with hormonal contraceptives or following antibiotic or proton pump inhibitor exposure, cyclical (menstrual) pruritus, and other liver or biliary conditions (particularly hepatitis C or gallstones).[6]Kenyon AP, Tribe RM, Nelson-Piercy C, et al. Pruritus in pregnancy: a study of anatomical distribution and prevalence in relation to the development of obstetric cholestasis. Obstet Med. 2010 Mar;3(1):25-9.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4989767
http://www.ncbi.nlm.nih.gov/pubmed/27582836?tool=bestpractice.com
[41]Perrault F, Echelard P, Viens D, et al. Contraceptive vaginal ring-induced cholestasis in a patient with a history of intrahepatic cholestasis of pregnancy. Clin Res Hepatol Gastroenterol. 2021 Jul;45(4):101475.
http://www.ncbi.nlm.nih.gov/pubmed/32651076?tool=bestpractice.com
[78]Zhang Y, Shi D, Abagyan R, et al. Population scale retrospective analysis reveals potential risk of cholestasis in pregnant women taking omeprazole, lansoprazole, and amoxicillin. Interdiscip Sci. 2019 Jun;11(2):273-81.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7172024
http://www.ncbi.nlm.nih.gov/pubmed/31106388?tool=bestpractice.com
Similarly, women may report a family history of ICP.[31]Turunen K, Helander K, Mattila KJ, et al. Intrahepatic cholestasis of pregnancy is common among patients' first-degree relatives. Acta Obstet Gynecol Scand. 2013 Sep;92(9):1108-10.
https://obgyn.onlinelibrary.wiley.com/doi/10.1111/aogs.12168
http://www.ncbi.nlm.nih.gov/pubmed/23663193?tool=bestpractice.com
Physical examination
Excoriations are common, and can develop secondary infection, but no other rash is indicative of the condition.[5]Ovadia C, Williamson C. Intrahepatic cholestasis of pregnancy: recent advances. Clin Dermatol. 2016 May-Jun;34(3):327-34.
http://www.ncbi.nlm.nih.gov/pubmed/27265070?tool=bestpractice.com
Around 10% of women have jaundice, evident by yellow sclerae.[5]Ovadia C, Williamson C. Intrahepatic cholestasis of pregnancy: recent advances. Clin Dermatol. 2016 May-Jun;34(3):327-34.
http://www.ncbi.nlm.nih.gov/pubmed/27265070?tool=bestpractice.com
[10]Conti-Ramsden F, McEwan M, Hill R, et al. Detection of additional abnormalities or co-morbidities in women with suspected intrahepatic cholestasis of pregnancy. Obstet Med. 2020 Dec;13(4):185-91.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7726172
http://www.ncbi.nlm.nih.gov/pubmed/33343695?tool=bestpractice.com
[12]Reyes H, Radrigan ME, Gonzalez MC, et al. Steatorrhea in patients with intrahepatic cholestasis of pregnancy. Gastroenterology. 1987 Sep;93(3):584-90.
https://www.gastrojournal.org/article/0016-5085(87)90922-X/pdf
http://www.ncbi.nlm.nih.gov/pubmed/3609667?tool=bestpractice.com
Women may have some right upper quadrant tenderness on examination, but ICP is not otherwise associated with clinical abnormalities on abdominal examination. ICP is not associated with abnormalities on obstetric examination - there is not an established association with growth restriction of the fetus.
Given that the condition is associated with increased rates of gestational diabetes mellitus and pre-eclampsia, physical examination should also consider features of these associated conditions, such as accelerated fetal growth, polyhydramnios, glucosuria, proteinuria, hypertension, hyperreflexia, epigastric pain, and peripheral oedema.
Laboratory
As pruritus occurs in more than 20% of pregnant women, diagnosis is dependent on elevation of serum bile acid concentrations, commonly with associated liver dysfunction. The following tests are recommended:[10]Conti-Ramsden F, McEwan M, Hill R, et al. Detection of additional abnormalities or co-morbidities in women with suspected intrahepatic cholestasis of pregnancy. Obstet Med. 2020 Dec;13(4):185-91.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7726172
http://www.ncbi.nlm.nih.gov/pubmed/33343695?tool=bestpractice.com
[14]Girling J, Knight CL, Chappell L, et al. Intrahepatic cholestasis of pregnancy: green-top guideline no. 43 June 2022. BJOG. 2022 Aug 9 [Epub ahead of print].
https://obgyn.onlinelibrary.wiley.com/doi/10.1111/1471-0528.17206
http://www.ncbi.nlm.nih.gov/pubmed/35942656?tool=bestpractice.com
[76]Society for Maternal-Fetal Medicine; Lee RH, Greenberg M, Metz TD, et al. Society for Maternal-Fetal Medicine consult series #53: Intrahepatic cholestasis of pregnancy: replaces consult #13, April 2011. Am J Obstet Gynecol. 2021 Feb;224(2):B2-9.
https://www.ajog.org/article/S0002-9378(20)31284-9/fulltext
http://www.ncbi.nlm.nih.gov/pubmed/33197417?tool=bestpractice.com
[79]European Association for the Study of the Liver. Electronic address: easloffice@easloffice.eu, European Association for the Study of the Liver. EASL clinical practice guidelines on the management of liver diseases in pregnancy. J Hepatol. 2023 Sep;79(3):768-828.
https://www.journal-of-hepatology.eu/article/S0168-8278(23)00181-2/fulltext
http://www.ncbi.nlm.nih.gov/pubmed/37394016?tool=bestpractice.com
[80]Kothari S, Afshar Y, Friedman LS, et al. AGA clinical practice update on pregnancy-related gastrointestinal and liver disease: expert review. Gastroenterology. 2024 Oct;167(5):1033-45.
https://www.gastrojournal.org/article/S0016-5085(24)05118-7/fulltext
http://www.ncbi.nlm.nih.gov/pubmed/39140906?tool=bestpractice.com
Total serum bile acid concentrations: above the upper limit of the laboratory normal range
Alanine aminotransferase: raised above pregnancy-specific concentrations in around 80% of women with ICP
Bilirubin: raised above pregnancy-specific concentrations in around 10% of women with ICP
Alternative liver enzymes, such as aspartate aminotransferase and gamma-glutamyl transferase, can also be elevated in ICP.
If bilirubin elevation is marked or persistent, consider investigations to identify the cause.[79]European Association for the Study of the Liver. Electronic address: easloffice@easloffice.eu, European Association for the Study of the Liver. EASL clinical practice guidelines on the management of liver diseases in pregnancy. J Hepatol. 2023 Sep;79(3):768-828.
https://www.journal-of-hepatology.eu/article/S0168-8278(23)00181-2/fulltext
http://www.ncbi.nlm.nih.gov/pubmed/37394016?tool=bestpractice.com
Alternative diagnostic laboratory tests have not been found to be superior to the measurement of total bile acid concentrations, or are not routinely available.[54]Kremer AE, Bolier R, Dixon PH, et al. Autotaxin activity has a high accuracy to diagnose intrahepatic cholestasis of pregnancy. J Hepatol. 2015 Apr;62(4):897-904.
http://www.ncbi.nlm.nih.gov/pubmed/25450205?tool=bestpractice.com
[81]Manzotti C, Casazza G, Stimac T, et al. Total serum bile acids or serum bile acid profile, or both, for the diagnosis of intrahepatic cholestasis of pregnancy. Cochrane Database Syst Rev. 2019 Jul 5;7(7):CD012546.
https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD012546.pub2/full
http://www.ncbi.nlm.nih.gov/pubmed/31283001?tool=bestpractice.com
These include measurement of individual bile acid concentrations and the enzyme autotaxin levels or activity. Diagnostic liver biopsy is not recommended.
Additional testing should be selected on the basis of the patient history and risk factors present, for example:
Auto-antibody tests: such as anti-smooth muscle and anti-mitochondrial antibodies for chronic active hepatitis and primary biliary cholangitis
Virology testing: hepatitis C, Epstein-Barr virus (in women with a history of preceding infectious symptoms), and cytomegalovirus
Coagulation testing: women with steatorrhoea or evidence of marked liver synthetic impairment (e.g., low albumin) are at risk of coagulopathy, although this is not evident in the whole population of women with ICP, and thus routine testing is not recommended[82]Furrer R, Winter K, Schäffer L, et al. Postpartum blood loss in women treated for intrahepatic cholestasis of pregnancy. Obstet Gynecol. 2016 Nov;128(5):1048-52.
https://www.zora.uzh.ch/id/eprint/126808
http://www.ncbi.nlm.nih.gov/pubmed/27741180?tool=bestpractice.com
Full blood count: to exclude anaemia as an alternative cause for pruritus.[83]Lewiecki EM, Rahman F. Pruritus. A manifestation of iron deficiency. JAMA. 1976 Nov 15;236(20):2319-20.
http://www.ncbi.nlm.nih.gov/pubmed/989837?tool=bestpractice.com
Laboratory tests to rule out alternative diagnoses can be considered, according to history and examination findings (e.g., ultrasound is commonly performed to exclude co-existent liver and biliary tree pathology). It is important to ensure that maternal serum bile acid and liver transaminase concentrations return to normal by 3 months postnatally.[79]European Association for the Study of the Liver. Electronic address: easloffice@easloffice.eu, European Association for the Study of the Liver. EASL clinical practice guidelines on the management of liver diseases in pregnancy. J Hepatol. 2023 Sep;79(3):768-828.
https://www.journal-of-hepatology.eu/article/S0168-8278(23)00181-2/fulltext
http://www.ncbi.nlm.nih.gov/pubmed/37394016?tool=bestpractice.com
If a woman has ongoing abnormalities, further investigations should be performed to exclude co-existing hepatic pathology.