Diagnostic Accuracy of Alanine Aminotransferase in Intrahepatic Cholestasis of Pregnancy and its Association with Maternal & Fetal/Neonatal Complications

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.