Intrahepatic Cholestasis of Pregnancy
Conditions
Interventions
Sponsors
Chengdu Women and Children's Central Hospital
Eligibility
Sex/Gender
Female
Age
20 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Presence of typical pruritus without rash, and exclusion of other diseases that may cause pruritus. 2.Maternal fasting total bile acid (TBA) >= 10 µmol/L or postprandial TBA >= 19 µmol/L. 3.In cases with normal serum total bile acid concentration but unexplained liver function abnormalities, mainly elevated serum alanine aminotransferase and aspartate aminotransferase, which may be accompanied by increased serum bilirubin and gamma-glutamyl transferase concentrations. 4.Pruritus and liver function abnormalities resolve spontaneously after delivery. 5.The diagnosis of ICP must be established by excluding other causes of pruritus or abnormal laboratory results such as elevated serum TBA. Routine ultrasound examination is recommended to rule out hepatobiliary diseases in pregnant women.
Exclusion criteria
Exclusion criteria: 1.Complications during pregnancy including hypertensive disorders of pregnancy, gestational hyperglycemia, nephropathy, thyroid disease, autoimmune disease, or use of other medications affecting liver function (e.g., heparinoids). 2.Complications during pregnancy including primary hepatobiliary diseases such as viral hepatitis, acute fatty liver of pregnancy, cholecystolithiasis, primary biliary cholangitis. 3.Patients with systemic or local infectious symptoms during pregnancy. 4.Patients with incomplete laboratory test results or data during pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse pregnancy outcomes; | — |
Secondary
| Measure | Time frame |
|---|---|
| Receiver Operating Characteristic curve;Area Under the Curve;Accuracy Rate (ACC);Recall;F1 Score;Decision Curve Analysis;Calibration Curve; | — |
Countries
China
Contacts
Public ContactYi Deng
Chengdu Women and Children's Central Hospital
Outcome results
None listed