Diagnostic Accuracy of Alanine Aminotransferase in Intrahepatic Cholestasis of Pregnancy and its Association with Maternal & Fetal/Neonatal Complications
Keywords:
Alanine aminotransferase, Bile acids, Intrahepatic cholestasisAbstract
Objective: To estimate the accuracy of alanine aminotransferase (ALT), using bile acid levels as the gold standard in the diagnosis of intrahepatic cholestasis of pregnancy (ICP) and to assess the maternal & fetal/neonatal complications between ICP cases and healthy pregnant females as well as cases with high and very high ALT levels.
Methodology: After approval from the ethical committee, this cross-sectional study was carried out at the Department of Obstetrics and Gynecology, Mohi-ud-Din Islamic Medical College, Mirpur during six months from September 2024 to February 2025. Using non-probability convenience sampling, 2500 pregnant women were included after taking their informed consent. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and diagnostic accuracy of ALT were evaluated using bile acid levels as a gold standard. The frequencies of maternal and fetal/neonatal complications were compared between cases of ICP and healthy pregnant females and cases with high ALT (41-100 IU/L) and very high ALT levels (>100 IU/L). Data was analyzed using the Statistical Package for the Social Sciences (SPSS) version 26.
Results: The frequency of ICP was 2.4%. Serum ALT has a sensitivity of 83.3%, specificity of 99%, and diagnostic accuracy of 98.6%. A receiver operating characteristic (ROC) curve showed an area under the curve of 0.911 indicating excellent diagnostic accuracy. Preterm delivery, induction of labor, low birth weight, and respiratory distress were more significant in patients with ALT levels >100 IU/L.
Conclusion: Serum ALT is a reliable marker for the diagnosis of ICP with high sensitivity, specificity, and diagnostic accuracy. The maternal and fetal/neonatal complications were significantly higher in patients with ICP particularly those with very high ALT levels.
References
1. Kong C, Zhu Z, Mei F. Risk factors associated with cesarean section and adverse fetal outcomes in intrahepatic cholestasis of pregnancy. Front Pediatr. 2023; 11:1136244. doi:10.3389/fped.2023.1136244.
2. Hague WM, Briley A, Callaway L, Dekker Nitert M, Gehlert J, Graham D, et al. Intrahepatic cholestasis of pregnancy - diagnosis and management: a consensus statement of the Society of Obstetric Medicine of Australia and New Zealand (SOMANZ): executive summary. Aust N Z J Obstet Gynaecol. 2023; 63(5):656-65. doi:10.1111/ajo.13719.
3. Gao XX, Ye MY, Liu Y, Li JY, Li L, Chen W, et al. Prevalence and risk factors of intrahepatic cholestasis of pregnancy in a Chinese population. Sci Rep. 2020; 10(1):16307. doi:10.1038/s41598-020-73378-5.
4. Wang P, Yuan P, Lin S, Zhong H, Zhang X, Zhuo Y, et al. Maternal and fetal bile acid homeostasis regulated by sulfated progesterone metabolites through FXR signaling pathway in a pregnant sow model. Int J Mol Sci. 2022; 23(12):6496. doi:10.3390/ijms23126496.
5. Majsterek M, Wierzchowska-Opoka M, Makosz I, Kreczynska L, Kimber-Trojnar Z, Leszczynska-Gorzelak B. Bile acids in intrahepatic cholestasis of pregnancy. Diagnostics (Basel). 2022; 12(11):2746. doi:10.3390/diagnostics12112746.
6. Huri M, Seravalli V, Lippi C, Tofani L, Galli A, Petraglia F, et al. Intrahepatic cholestasis of pregnancy - time to redefine the reference range of total serum bile acids: a cross-sectional study. BJOG. 2022; 129(11):1887-96. doi:10.1111/1471-0528.17174.
7. Piechota J, Jelski W. Intrahepatic cholestasis in pregnancy: review of the literature. J Clin Med. 2020; 9(5):1361. doi:10.3390/jcm9051361.
8. Zhu Y, Xu L, Beejadhursing R, Li F. Maternal and neonatal outcomes of intrahepatic cholestasis of pregnancy after in vitro fertilization. BMC Pregnancy Childbirth. 2024; 24(1):44. doi:10.1186/s12884-024-06248-x.
9. Misra D, Singh N, Faruqi M, Tiwari V, Kumar V, Zafar F. Evaluating the utility of liver transaminases as predictors of feto-maternal outcome in lieu of serum bile acids in intrahepatic cholestasis of pregnancy: a prospective observational study. J Obstet Gynaecol India. 2024; 74(2):113-8. doi:10.1007/s13224-023-01881-6.
10. Nahm FS. Receiver operating characteristic curve: overview and practical use for clinicians. Korean J Anesthesiol. 2022; 75(1):25-36. doi:10.4097/kja.21209.
11. Niemyjska-Dmoch W, Kosinski P, Wegrzyn P, Luterek K, Jezela-Stanek A. Intrahepatic cholestasis of pregnancy and theory of inheritance of the disease. Literature review. J Matern Fetal Neonatal Med. 2023; 36(2):2279020. doi:10.1080/14767058.2023.2279020.
12. Aftab N, Faraz S, Hazari K, Mahgoub FB. Maternal and fetal outcome in intrahepatic cholestasis of pregnancy in a multicultural society conducted at a tertiary care hospital in Dubai. Dubai Med J 2021; 4(1):53-9. doi:10.1159/000513717.
13. Qurat ul Ain, Mir RA, Rather SY. Maternal and fetal outcome in intrahepatic cholestasis of pregnancy at tertiary care institute of Kashmir Valley in North India. IJCMR. 2023; 10(5):E1-4. Available from: https://www. ijcmr.com/uploads/7/7/4/6/77464738/ijcmr_3712.pdf.
14. Chen Y, Zhang H, Ning W, Chen Y, Wen C. The impact of intrahepatic cholestasis on pregnancy outcomes: a retrospective cohort study. BMC Gastroenterol. 2023; 23(1):16. doi:10.1186/s12876-023-02652-3.
15. Wu K, Yin B, Li S, Zhu X, Zhu B. Prevalence, risk factors and adverse perinatal outcomes for Chinese women with intrahepatic cholestasis of pregnancy: a large cross-sectional retrospective study. Ann Med. 2022; 54(1):2966-74. doi:10.1080/07853890.2022.2136400.
16. Tasin C, Ciftci RS. The relationship of bile acid with biochemical tests in the diagnosis of intrahepatic cholestasis of pregnancy. J Exp Clin Med. 2021; 38(4):485-9. doi:10.52142/omujecm.38.4.16.
17. Zhou Q, Yuan Y, Wang Y, He Z, Liang Y, Qiu S, et al. The severity of intrahepatic cholestasis during pregnancy increases risks of adverse outcomes beyond stillbirth: evidence from 15,826 patients. BMC Pregnancy Childbirth. 2024; 24(1):476. doi:10.1186/s12884-024-06645-2.
18. Hassan GU, Inam I, Sajjad S. Pregnancy outcomes with intrahepatic cholestasis. PJMHS. 2022; 16(05):216-8. doi:10.53350/pjmhs22165216.
19. Feng F, Li J, Liao J, Qin S, Liu Y, Che X, et al. Associations of clinical subtypes and bile acid levels of intrahepatic cholestasis of pregnancy with pregnancy outcomes. Sci Rep. 2024; 14(1):12185. doi:10.1038/ s41598-024-63183-9.
Downloads
Published
Issue
Section
License
Copyright (c) 2025 Journal of Sharif Medical & Dental College is licensed and distributed under the terms of Creative Commons Attribution-NonCommercial 4.0 International License.
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
