Pregnant women with a specific liver condition will be randomised to receive a treatment that is currently used compared with a placebo, looking at the health of their babies.

Phase 1

• Conditions: Intrahepatic Cholestasis of pregnancy; MedDRA version: 17.1 Level: LLT Classification code 10008638 Term: Cholestasis intrahepatic System Organ Class: 100000004871; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2014-004478-41-GB
• Lead Sponsor: King's College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-06
• Study Completion: 2018-11-28
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 605

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 (see note below on gestational age)
No known lethal fetal anomaly
Singleton or twin pregnancy
Aged 18 years or over
Able to give written informed consent
Determination of gestational age: for all calculations relating to gestational age (eligibility for enrolment, gestational age at delivery), gestational age will be calculated based on the following hierarchical model, as set out in the NICE guidelines for antenatal care:
? From crown-rump length measurement on early ultrasound scan between 10+0 weeks and 13+6 weeks
? From head circumference on ultrasound scan if crown–rump length is above 84 mm
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 580
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified