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© The Author(s). 2018. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.

Abstract

Background

Intrahepatic cholestasis of pregnancy (ICP) is the most common liver disorder specific to pregnancy and presents with maternal pruritus, raised concentrations of serum bile acids and abnormal liver function tests. ICP is associated with increased rates of spontaneous and iatrogenic preterm labour, fetal hypoxia, meconium-stained amniotic fluid and intrauterine death. Some clinicians treat ICP with ursodeoxycholic acid (UDCA) to improve maternal pruritus and biochemical abnormalities. However, there are currently no data to support the use of UDCA to improve pregnancy outcome as none of the trials performed to date have been powered to address this question.

Methods

The PITCHES trial is a triple-masked, placebo-controlled randomised trial, to evaluate UDCA versus placebo in women with ICP between 20 + 0 to 40 + 6 weeks’ gestation. The primary objective of the trial is to determine if UDCA treatment of women with ICP between 20 + 0 and 40 + 6 weeks’ gestation reduces the primary perinatal outcome: a composite of perinatal death (as defined by in utero fetal death after randomisation or known neonatal death up to 7 days) or preterm delivery (less than 37 weeks’ gestation) or neonatal unit admission for at least 4 h (from infant delivery until hospital discharge). The secondary objectives of the trial are (1) to investigate the effect of UDCA on other short-term outcomes for both mother and infant and (2) to assess the impact of UDCA on health care resource use, in terms of the total number of nights for mother and infant, together with level of care.

Discussion

Current practice in the UK at the time of trial commencement for the treatment of ICP is inconsistent, with some units routinely prescribing UDCA, others prescribing very little and the remainder offering it variably. Our previous pilot trial of UDCA in women with ICP demonstrated that the trial would be feasible, and the research question remains active and unanswered. Results are highly likely to influence clinical practice, through direct management and impact on national and international guidelines.

Trial registration

ISRCTN registry, ID: ISRCTN91918806. Prospectively registered on 27 August 2015.

Details

Title
Ursodeoxycholic acid versus placebo in the treatment of women with intrahepatic cholestasis of pregnancy (ICP) to improve perinatal outcomes: protocol for a randomised controlled trial (PITCHES)
Author
Chappell, Lucy C. 1   VIAFID ORCID Logo  ; Chambers, Jenny 2 ; Dixon, Peter H. 1 ; Dorling, Jon 3 ; Hunter, Rachael 4 ; Bell, Jennifer L. 5 ; Bowler, Ursula 5 ; Hardy, Pollyanna 6 ; Juszczak, Edmund 5 ; Linsell, Louise 5 ; Rounding, Catherine 5 ; Smith, Anne 5 ; Williamson, Catherine 1 ; Thornton, Jim G. 7 

 King’s College London, London, UK (GRID:grid.13097.3c) (ISNI:0000 0001 2322 6764) 
 ICP Support, Sutton Coldfield, UK (GRID:grid.13097.3c) 
 Dalhousie University, Halifax, Canada (GRID:grid.55602.34) (ISNI:0000 0004 1936 8200) 
 University College London, London, UK (GRID:grid.83440.3b) (ISNI:0000000121901201) 
 National Perinatal Epidemiology Unit Clinical Trials Unit, University of Oxford, Oxford, UK (GRID:grid.4991.5) (ISNI:0000 0004 1936 8948) 
 Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK (GRID:grid.6572.6) (ISNI:0000 0004 1936 7486) 
 University of Nottingham, Nottingham, UK (GRID:grid.4563.4) (ISNI:0000 0004 1936 8868) 
Pages
657
Publication year
2018
Publication date
Dec 2018
Publisher
BioMed Central
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
2795281905
Copyright
© The Author(s). 2018. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.