title: Ursodeoxycholic acid in the treatment of intrahepatic cholestasis of pregnancy: a randomized controlled trial.
abstract: OBJECTIVE
  To test the efficacy and safety of ursodeoxycholic acid (UDCA) in the treatment of patients with intrahepatic cholestasis of pregnancy (ICP).
  
  
  METHODS
  In the randomized (double-blind, placebo-controlled) study 20 pregnant women with ICP received (random allocation of) either 450 mg/day UDCA or placebo for 14 days during the third trimester of pregnancy. The severity of pruritus was registered and itching scores were assessed before the treatment and weekly thereafter. The effects of UDCA on liver function and fetoplacental hormone production were measured with covering laboratory testing: serum levels of alanine aminotransferase (ALAT), total bile acids (TBA), estradiol, progesterone, prolactin, cholesterol, HDL-cholesterol, triglycerides, activated partial thromboplastin time, fibrinogen D-dimers (FIDD) and platelet count were assessed before the treatment and weekly thereafter. Data on pregnancy and delivery outcome were recorded and analyzed.
  
  
  RESULTS
  UDCA was well tolerated. A significant improvement in itching scores was detected in 2 weeks in the group receiving UDCA. Serum levels of ALAT and TBA fell after 2 weeks treatment. The other laboratory values were not modified by the treatment.
  
  
  CONCLUSIONS
  UDCA improves maternal itching scores and liver function tests without interfering with the fetoplacental estrogen production in patients with ICP. UDCA is well tolerated by pregnant women. No fetal or neonatal side-effects could be detected.
authors: Department of Obstetrics and Gynecology, Turku University Central Hospital, Kiinamyllynkatu 4-8, 20520, Turku, Finland, titta.joutsiniemi@tyks.fi.
authors: Titta
authors: T
authors: Joutsiniemi
authors: Susanna
authors: S
authors: Timonen
authors: Riitta
authors: R
authors: Leino
authors: Pertti
authors: P
authors: Palo
authors: Ulla
authors: U
authors: Ekblad
mesh_terms: D000293:Adolescent; D000328:Adult; D015415:Biomarkers / Q000097:blood; D002756:Cholagogues and Choleretics / Q000627:therapeutic use*; D002780:Cholestasis, Intrahepatic / Q000097:blood / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D005387:Finland; D006801:Humans; D008111:Liver Function Tests; D010919:Placebos; D011247:Pregnancy; D011248:Pregnancy Complications / Q000097:blood / Q000188:drug therapy*; D011256:Pregnancy Outcome; D011263:Pregnancy Trimester, Third; D011537:Pruritus / Q000139:chemically induced; D016896:Treatment Outcome; D014580:Ursodeoxycholic Acid / Q000627:therapeutic use*
chemical_list: D015415:Biomarkers; D002756:Cholagogues and Choleretics; D010919:Placebos; D014580:Ursodeoxycholic Acid