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 III trial in IntrahepaTic CHolestasis of pregnancy (ICP) to Evaluate urSodeoxycholic acid (UDCA) in improving perinatal outcomes - PITCHES: Phase III trial of UDCA in ICP: V1

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004478-41-GB

Enrollment

580

Registered

2015-03-06

Start date

2015-03-10

Completion date

Unknown

Last updated

2019-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intrahepatic Cholestasis of pregnancy MedDRA version: 17.1 Level: LLT Classification code 10008638 Term: Cholestasis intrahepatic System Organ Class: 100000004871

Interventions

Trade Name: Ursofalk Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Ursodeoxycholic acid CAS Number: 128-13-2 Other descri

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Intrahepatic cholestasis of pregnancy (ICP), or obstetric cholestasis (OC) is a liver condition of pregnancy. Pregnant women diagnosed with ICP are more at risk of suffering from in utero fetal death, stillbirth, perinatal death (under 7 days), preterm delivery (less than 37 weeks' gestation) and neonatal unit admission. The principal research question asks: does treatment with ursodeoxycholic acid (UDCA) in ICP women, increase the chance of having a healthy baby, by reducing the problems listed above?;Secondary Objective: The secondary research objectives of the study are to investigate the effect of UDCA treated ICP on other short term outcomes for both the mother and baby; and to assess the impact of UDCA treated ICP on health resource use: in terms of the total number of nights for mother and neonate, including intensive care and mode of delivery.; Primary end point(s): The primary short term perinatal outcome is a composite of perinatal death (as defined by in utero fetal death from 20+0 and 23+6 weeks’ gestation or stillbirth before delivery > 24+0 weeks’ gestation or neonatal death up to 7 days but not death due to congenital anomaly) or preterm delivery (less than 37 weeks’ gestation) or NNU admissions (from infant delivery until hospital discharge to home). Each infant will only be counted once within this composite. ; Timepoint(s) of evaluation of this end point: The time points of evaluation of this outcome measure are: For deaths: between randomisation and 7 days post infant delivery For preterm delivery: between randomisation and upto 37 weeks gestation For infant neonatal unit admission: between randomisation and infant discharge (from hospital to home)	—

Measure

Time frame

Main Objective: Intrahepatic cholestasis of pregnancy (ICP), or obstetric cholestasis (OC) is a liver condition of pregnancy. Pregnant women diagnosed with ICP are more at risk of suffering from in utero fetal death, stillbirth, perinatal death (under 7 days), preterm delivery (less than 37 weeks' gestation) and neonatal unit admission. The principal research question asks: does treatment with ursodeoxycholic acid (UDCA) in ICP women, increase the chance of having a healthy baby, by reducing the problems listed above?;Secondary Objective: The secondary research objectives of the study are to investigate the effect of UDCA treated ICP on other short term outcomes for both the mother and baby; and to assess the impact of UDCA treated ICP on health resource use: in terms of the total number of nights for mother and neonate, including intensive care and mode of delivery.; Primary end point(s): The primary short term perinatal outcome is a composite of perinatal death (as defined by in utero fetal death from 20+0 and 23+6 weeks’ gestation or stillbirth before delivery > 24+0 weeks’ gestation or neonatal death up to 7 days but not death due to congenital anomaly) or preterm delivery (less than 37 weeks’ gestation) or NNU admissions (from infant delivery until hospital discharge to home). Each infant will only be counted once within this composite. ; Timepoint(s) of evaluation of this end point: The time points of evaluation of this outcome measure are: For deaths: between randomisation and 7 days post infant delivery For preterm delivery: between randomisation and upto 37 weeks gestation For infant neonatal unit admission: between randomisation and infant discharge (from hospital to home)

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Secondary

Measure	Time frame
Secondary end point(s): The secondary short term maternal outcomes are: • Peak maternal serum concentration (between randomisation and delivery) of following biochemical indices of disease: o Bile acids o Alanine transaminase o Bilirubin (total) o Gamma glutamyl transferase • Worst episode of itch over past 24 hours (mm on visual analogue scale) between randomisation and delivery (assessed at clinic visits) • Maximum dose of trial medication required • Need for additional therapy • Gestational diabetes mellitus • Gestational Hypertension/Preeclampsia • Assessment of myometrial contractions by CTG approximately one week (314 days) post randomisation • Mode of onset of labour • Mode of delivery classified as spontaneous vaginal, instrumental vaginal or caesarean • Reason for induction or prelabour caesarean section • Estimated blood loss after delivery The secondary short term perinatal outcomes are: • In utero fetal death 20+0 to 23+6 weeks’ gestation • Stillbirth (death before delivery > 24+0 weeks’ gestation) • Preterm delivery (less than 37 weeks’ gestation) • Neonatal death up to 7 days (excluding death due to congenital anomaly) • Neonatal death up to 28 days (excluding death due to congenital anomaly) • NNU admissions until infant hospital discharge to home • Number of nights in each category of care (intensive, high dependency, special, transitional and normal) • Total number of nights in hospital • Birth weight (g) • Customised/population birth weight centil	—

Measure

Time frame

Secondary end point(s): The secondary short term maternal outcomes are: • Peak maternal serum concentration (between randomisation and delivery) of following biochemical indices of disease: o Bile acids o Alanine transaminase o Bilirubin (total) o Gamma glutamyl transferase • Worst episode of itch over past 24 hours (mm on visual analogue scale) between randomisation and delivery (assessed at clinic visits) • Maximum dose of trial medication required • Need for additional therapy • Gestational diabetes mellitus • Gestational Hypertension/Preeclampsia • Assessment of myometrial contractions by CTG approximately one week (314 days) post randomisation • Mode of onset of labour • Mode of delivery classified as spontaneous vaginal, instrumental vaginal or caesarean • Reason for induction or prelabour caesarean section • Estimated blood loss after delivery The secondary short term perinatal outcomes are: • In utero fetal death 20+0 to 23+6 weeks’ gestation • Stillbirth (death before delivery > 24+0 weeks’ gestation) • Preterm delivery (less than 37 weeks’ gestation) • Neonatal death up to 7 days (excluding death due to congenital anomaly) • Neonatal death up to 28 days (excluding death due to congenital anomaly) • NNU admissions until infant hospital discharge to home • Number of nights in each category of care (intensive, high dependency, special, transitional and normal) • Total number of nights in hospital • Birth weight (g) • Customised/population birth weight centil

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Countries

United Kingdom

Contacts

Public ContactDr Lucy Chappell

King's College London

lucy.chappell@kcl.ac.uk00442071883639

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026