Ursodeoxycholic acid versus placebo, and early term delivery versus expectant management, in women with intrahepatic cholestasis of pregnancy: semifactorial randomised clinical trial.

ABSTRACT:

Objectives

To test whether ursodeoxycholic acid reduces pruritus in women with intrahepatic cholestasis of pregnancy, whether early term delivery does not increase the incidence of caesarean section, and the feasibility of recruiting women with intrahepatic cholestasis of pregnancy to trials of these interventions.

Design

First phase of a semifactorial randomised controlled trial.

Setting

Nine consultant led maternity units, United Kingdom.

Participants

125 women with intrahepatic cholestasis of pregnancy (pruritus and raised levels of serum bile acids) or pruritus and raised alanine transaminase levels (>100 IU/L) recruited after 24 weeks' gestation and followed until delivery. 56 women were randomised to ursodeoxycholic acid, 55 to placebo, 30 to early term d

SUBMITTER: Chappell LC 

PROVIDER: S-EPMC3420230 | biostudies-literature | 2012 Jun

REPOSITORIES: biostudies-literature