From the Guidelines
Relationship Between Bile Acid Levels and Delivery Timing in ICP
The relationship between bile acid levels and delivery timing in intrahepatic cholestasis of pregnancy (ICP) is directly correlated, with higher bile acid levels associated with an increased risk of stillbirth, particularly after 36 weeks of gestation 1.
Recommended Dosing for Ursodiol (UDCA)
The recommended dosing for Ursodiol (ursodeoxycholic acid, UDCA) is 10-15 mg/kg/day, administered orally, to alleviate maternal symptoms of ICP 1.
Key Recommendations
- Measurement of serum bile acid and liver transaminase levels is recommended in patients with suspected ICP 1.
- UDCA is recommended as the first-line agent for the treatment of maternal symptoms of ICP 1.
- Delivery timing should be based on serum total bile acid levels, with delivery recommended at 36 weeks for patients with levels >100 mmol/L and between 36 and 39 weeks for patients with levels <100 mmol/L 1.
- Antenatal fetal surveillance should be initiated at a gestational age when delivery would be performed in response to abnormal fetal testing results or at the time of diagnosis if made later in gestation 1.
- Antenatal corticosteroids should be administered for fetal lung maturity in patients delivering before 37 weeks of gestation if not previously administered 1.
Clinical Considerations
- Pruritus typically resolves after delivery, but if it persists after 6 weeks, further evaluation for underlying chronic liver disease should be pursued 1.
- Serum bile acid levels should be monitored regularly, as they may continue to rise with advancing gestation 1.
- Individualized management is recommended, taking into account the patient's specific clinical presentation and serum bile acid levels 1.
From the FDA Drug Label
DOSAGE AND ADMINISTRATION Gallstone Dissolution The recommended dose for ursodiol capsules treatment of radiolucent gallbladder stones is 8 to 10 mg/kg/day given in 2 or 3 divided doses. CLINICAL PHARMACOLOGY About 90% of a therapeutic dose of ursodiol is absorbed in the small bowel after oral administration. There is no information in the provided drug labels about the relationship between bile acid levels and delivery timing in intrahepatic cholestasis of pregnancy (ICP). The recommended dosing for Ursodiol (ursodeoxycholic acid, UDCA) is 8 to 10 mg/kg/day given in 2 or 3 divided doses for the treatment of radiolucent gallbladder stones 2.
From the Research
Relationship between Bile Acid Levels and Delivery Timing in ICP
- Bile acid levels are associated with the severity of intrahepatic cholestasis of pregnancy (ICP) and can impact delivery timing 3, 4, 5.
- Patients with severe ICP (bile acid levels ≥ 40 mmol/l) are at a higher risk of preterm labor, elective induction, and stillbirths compared to those with mild ICP (bile acid levels < 40 mmol/l) 3.
- Total bile acids tend to be higher in patients with preterm delivery, suggesting a correlation between bile acid levels and preterm delivery 5.
- Serial measurement of bile acid levels may help identify patients who progress to higher ICP severity, potentially leading to changes in delivery timing 4.
Recommended Dosing for Ursodiol (UDCA)
- The median dose of UDCA used in one study was 900 mg (range 600-1800 mg), which ameliorated symptoms of cholestasis, bile acid levels, and liver aminotransferases in 79% of cases 3.
- A study from 1997 used a daily dose of 1 g of UDCA, which improved pruritus, serum bilirubin, and liver enzymes in patients with ICP 6.
- Gradual dosing of UDCA may improve composite neonatal outcome, with a study suggesting that gradually increasing the dose until the desired dosage is reached may be associated with a greater gestational age at delivery and fewer unfavorable composite neonatal outcomes 7.