Role of ursodeoxycholic acid on maternal serum bile acids and perinatal outcomes in intrahepatic cholestasis of pregnancy.

AIM: Intrahepatic cholestasis of pregnancy (ICP) is associated with safe maternal outcomes but perinatal outcomes have been variable. We assessed clinical factors and impact of bile acid levels on maternal and neonatal outcomes in ICP.

METHODS

Patients with ICP (defined as pruritus with serum bile acids ≥ 10 mmol/l) were included prospectively with an assessment of risk factors, modes of delivery as well as maternal and neonatal outcomes. Mild and severe ICP were diagnosed when serum bile acid was always <40 mmol/l and ≥40 mmol/l, respectively. Patients with gestational pruritus served as controls.

RESULTS

Out of 643 patients, 375 patients (mean age 29 ± 7.6 years, 45.8% primigravida) met inclusion criteria. Pregnancy-induced hypertension [PIH: 10.5%; odds ratio (OR): 4.8; 95% confidence interval (CI): 2.4-8.5; P = 0.0014], gestational diabetes (GDM: 12.5%; OR: 2.6; 95% CI: 2.3-4.1; P = 0.045) and spontaneous preterm labor (15.1%; OR: 2.5; 95% CI: 1.2-3.5; P = 0.040) were higher in patients with ICP. Ursodeoxycholic acid (UDCA) (median dose 900 mg; 600-1800 mg) ameliorated symptoms of cholestasis, bile acid levels and liver aminotransferases in 79% cases. When compared with patients with mild ICP, patients with severe ICP presented at a lower gestational period (26 vs. 32 weeks, P = 0.036), required frequent induction (12.5%; OR: 3.2; 95% CI: 2.1-5.6; P = 0.045) and had increased fetal distress (15%; OR: 1.9; 95% CI: 1.3-4.9; P = 0.048).Overall eight stillbirths were recorded.

CONCLUSION

Severe ICP is associated with a higher incidence of GDM and PIH, risk of pre-term labor, elective induction and stillbirths. UDCA remains a first-line agent in treating ICP.