PITCHES

Recruitment
Total
449
Target
580

Participants recruited at St Richard's Hospital, Bradford Royal Infirmary and Queen's Medical Centre on 22 November 2017.

Introduction

PITCHES is a Phase III trial in IntrahepaTic CHolestasis of pregnancy to Evaluate urSodeoxycholic acid (UDCA) in improving perinatal outcomes.

The purpose of the Clinical trial is to provide definitive evidence for (or against) a role for UDCA in ameliorating adverse perinatal outcomes.

The trial is a masked placebo-controlled randomised trial to evaluate UDCA vs. placebo in women with ICP between 20+0 to 40+6 weeks' gestation.  The trial will be conducted at 30 centres across the UK and recruitment will run for approximately 39 months.

General Information

EudraCT No.:
2014-004478-41
REC Reference:
15/EE/0010
ISRCTN:
91918806
Clinical Trials Unit:
National Perinatal Epidemiology Unit CTU
Sponsor:
Co-sponsored by Kings College London and Guy's & St Thomas' NHS Foundation Trust
Funder:
The NIHR Efficacy and Mechanism Evaluation (EME) Programme
Duration of Study:
March 2015 - February 2019

Links

Eligibility

Inclusion criteria

  • ICP (pruritus with a raised serum bile acid above the upper limit of normal for the local laboratory)
  • 20+0 to 40+6 weeks' gestation on day of randomisation
  • No known lethal fetal anomaly
  • Singleton or twin pregnancy
  • Aged 18 years or over
  • Able to give written informed consent

Exclusion criteria

  • Decision already made for delivery within the next 48 hours
  • Known allergy to any component of the UDCA or placebo tablets
  • Triplet or higher-order multiple pregnancy

Study Treatment

UDCA 1g daily (500mg bd), increased in increments of 500mg per day every 3-14 days if there is no biochemical or clinical improvement, based on clinical decision, to a maximum of 2g per day. The dose of IMP may be reduced to 500mg daily. Administered orally as Ursofalk tablets each containing 500mg UDCA or matching placebo.

Primary objectives

The primary short term objective of the trial is to determine if UDCA treatment of women with ICP between 20+0 to 40+6 weeks of gestation reduces the following adverse perinatal outcomes up to infant hospital discharge:

  • In utero fetal death after randomisation
  • Known neonatal death up to 7 days
  • Preterm delivery (less than 37 weeks’ gestation)
  • Neonatal unit admission for at least 4 hours

Secondary objectives

The secondary objectives of the trial are to:

  • Investigate the effect of the intervention on other maternal and neonatal short-term outcomes.
  • Assess the impact of both management strategies on health economic outcomes.