title: The effects of ursodeoxycholic acid treatment for intrahepatic cholestasis of pregnancy on maternal and fetal outcomes: a meta-analysis including non-randomized studies.
abstract: OBJECTIVE
  The benefits of ursodeoxycholic acid (UDCA) use for treating intra-hepatic cholestasis of pregnancy (ICP) remain uncertain. A 2010 Cochrane Review of randomized control trials was unable to recommend either for or against the use of UDCA in treating ICP. We conducted a meta-analysis of the literature, including both non-randomized studies (NRSs) and RCTs. The objective of the study was to determine if patients included in NRSs were comparable to those in RCTs, and to determine whether the inclusion of NRSs could strengthen the available evidence and guide clinical practice on UDCA use in women with ICP.
  
  
  METHODS
  We searched Medline (Ovid), Embase (Ovid), EMB Reviews, Cinahl (Ebsco), and Web of Knowledge (Thomson Reuters) for articles published from 1966 to June 2012.
  
  
  METHODS
  We included all eligible RCTs of UDCA versus placebo or other treatments, and all NRSs comparing UDCA with any other treatment in women with ICP.
  
  
  RESULTS
  We included 11 RCTs (n = 625 pregnancies) and six NRSs (n = 211 pregnancies). The women included in RCTs and NRSs were comparable, but study quality was poorer for NRSs. Overall, women treated with UDCA had decreased pruritus in 73% of RCTs and in 100% of NRSs with available data. Liver function tests were improved in 82% of RCTs and in 100% of NRSs with available data. UDCA use did not affect the Caesarean section rate, but was associated with less prematurity, less use of neonatal intensive care units (data available in only 3/17 studies), and trends towards increased birth weight and decreased meconium staining. There were 0/356 stillbirths with UDCA and 3/399 stillbirths with comparator.
  
  
  CONCLUSIONS
  UDCA treatment should be recommended for women with ICP to reduce adverse maternal and fetal outcomes.
authors.affiliation: Department of Internal Medicine, Centre hospitalier de l'Université de Montréal, Montreal QC.
authors.forename: Sophie
authors.initials: S
authors.lastname: Grand'Maison
authors.affiliation: Department of Internal Medicine, Centre hospitalier de l'Université de Montréal, Montreal QC.
authors.forename: Madeleine
authors.initials: M
authors.lastname: Durand
authors.affiliation: Department of Internal Medicine, Centre hospitalier de l'Université de Montréal, Montreal QC.
authors.forename: Michèle
authors.initials: M
authors.lastname: Mahone
mesh_terms: D002780:Cholestasis, Intrahepatic / Q000188:drug therapy*; D005260:Female; D005333:Fetus / Q000187:drug effects*; D006801:Humans; D065228:Non-Randomized Controlled Trials as Topic; D011247:Pregnancy; D011248:Pregnancy Complications / Q000188:drug therapy*; D011256:Pregnancy Outcome; D014580:Ursodeoxycholic Acid / Q000627:therapeutic use*
chemical_list: D014580:Ursodeoxycholic Acid
keywords: intrahepatic cholestasis of pregnancy; maternal; prematurity; treatment; ursodeoxycholic acid