title: Efficacy and safety of ursodeoxycholic acid in patients with intrahepatic cholestasis of pregnancy.
abstract: Background and aims. Patients with intrahepatic cholestasis of pregnancy (ICP) benefit from ursodeoxycholic acid (UDCA) treatment. Since there is still certain reluctance to use UDCA in pregnant women, mainly due to warnings in the official SPC information in respective drug leaflets, our objective was to assess the efficacy and safety of UDCA during pregnancy.
  
  
  METHODS
  Our retrospective multicentric study was performed on 191 consecutive pregnant women with ICP treated with UDCA. Any maternal and/or fetal complications of the UDCA treatment were searched for; healthy pregnant women (n = 256) served as controls.
  
  
  RESULTS
  The UDCA treatment improved liver disease status in the majority of the affected women (86.1%). This treatment was well tolerated, with only negligible skin reactions (0.5%) and mild diarrhea (4.7%). No complications attributable to UDCA treatment were detected during the fetal life, delivery, or the early neonatal period.
  
  
  CONCLUSIONS
  We confirmed the good efficacy and safety of UDCA treatment in pregnancy for both mothers and fetuses/neonates.
authors: Department of Obstetrics and Gynaecology, 1st Faculty of Medicine, Charles University in Prague, Prague.
authors: Antonín
authors: A
authors: Parízek
authors: Department of Obstetrics and Gynaecology, 1st Faculty of Medicine, Charles University in Prague, Prague.
authors: Patrik
authors: P
authors: Simják
authors: Department of Obstetrics and Gynaecology, 1st Faculty of Medicine, Charles University in Prague, Prague.
authors: Andrej
authors: A
authors: Cerný
authors: Department of Obstetrics and Gynaecology, 1st Faculty of Medicine, Charles University in Prague, Prague.
authors: Alena
authors: A
authors: Sestinová
authors: Department of Obstetrics and Gynaecology, 1st Faculty of Medicine, Charles University in Prague, Prague.
authors: Anna
authors: A
authors: Zdenková
authors: Institute of Endocrinology, Prague.
authors: Martin
authors: M
authors: Hill
authors: Institute of Endocrinology, Prague.
authors: Michaela
authors: M
authors: Dusková
authors: Department of Obstetrics and Gynaecology, 2nd Faculty of Medicine, Charles University in Prague, Prague.
authors: Radovan
authors: R
authors: Vlk
authors: Department of Obstetrics and Gynaecology, Regional Hospital Pardubice, Pardubice.
authors: Zuzana
authors: Z
authors: Kokrdová
authors: Department of Obstetrics and Gynaecology, 1st Faculty of Medicine, Charles University in Prague, Prague.
authors: Michal
authors: M
authors: Koucký
authors: Institute of Medical Biochemistry and Laboratory Diagnostics; and 4th Department of Internal Medicine, 1st Faculty of Medicine, Charles University in Prague, Prague, all Czech Republic.
authors: Libor
authors: L
authors: Vítek
mesh_terms: D000328:Adult; D002756:Cholagogues and Choleretics / Q000009:adverse effects / Q000627:therapeutic use*; D002780:Cholestasis, Intrahepatic / Q000175:diagnosis / Q000188:drug therapy*; D018153:Czech Republic; D005260:Female; D006801:Humans; D011247:Pregnancy; D011248:Pregnancy Complications / Q000175:diagnosis / Q000188:drug therapy*; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D016896:Treatment Outcome; D014580:Ursodeoxycholic Acid / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D002756:Cholagogues and Choleretics; D014580:Ursodeoxycholic Acid