Ursodeoxycholic Acid And Cholestasis Of Pregnancy

Phase 3

Withdrawn

• Conditions: Intrahepatic Cholestasis of Pregnancy
• Interventions: Drug: Placebo; Drug: Ursodeoxycholic Acid

• Registration Number: NCT01226823
• Lead Sponsor: University of Bologna

Brief Summary

The study is a multicenter randomized double blind placebo controlled trial. The study will be conducted on pregnant women with a diagnosis of intrahepatic cholestasis of pregnancy (ICP) in third level hospitals (that are also Academic Hospitals).

Pregnant women at the time of ICP diagnosis will be randomized in two groups:

Group 1 - will receive placebo and obstetrical monitoring until delivery Group 2 - will receive UDCA at the dose of 20 mg/Kg/day and obstetrical monitoring until delivery.

The hypotheses are that UDCA treatment will be superior to placebo and effective in:

reducing the rate of prematurity; improving maternal biochemical parameters and symptoms.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-19
• Study First Submitted QC: 2010-10-21
• Study First Posted: 2010-10-22
• Study Start: 2010-11
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-10
• Last Update Posted: 2016-05-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Pregnant state (after week 20 of gestation)
• Total Serum BA elevation (>10 micromol/l)
• Transaminases elevation (ALT>40 UI/L and AST>37 UI/L)
• Occurrence of pruritus
• Informed consent signed

Exclusion Criteria

• Infectious diseases (HBV, HDV, HCV related liver disease, EBV, CMV, HIV infection)
• Dermatologic diseases
• Metabolic diseases (including alcohol abuse)
• Other causes of cholestasis (i.e. PBC; PSC)
• Autoimmune liver disease
• Obstructive biliary diseases
• Drug related pathologies
• Known or suspected hyper-sensibility to the drug or the pharmacological class under study
• Serious clinical conditions that, according to the judgment of the investigator, contraindicate the participation to the study (heart, kidney and liver disease)
• Use of cholestyramine
• Patients not able or not willing to follow the procedures of the protocol
• Patients not signing the informed consent
• Onset of ICP during of after the 36th week of pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	obstetrical monitoring plus placebo
Ursodeoxycholic acid	Ursodeoxycholic Acid	obstetrical monitoring plus active drug

Primary Outcome Measures

Name	Time	Method
Number of participants with preterm delivery (before week 37)	at the time of delivery

Secondary Outcome Measures

Name	Time	Method
Transaminases	from enrolment until delivery
APGAR index	1 and 5 minutes after birth
Number of pregnancies with Green stained amniotic fluid	at delivery	obstetrician evaluation
Pruritus on the Visual Analogue Scale	from enrollment until delivery
Bile Acids	from enrolment until delivery
Fetal movement count	from enrolment until delivery	mother evaluation
Number of pregnancies with cardiotocography suggestive of fetal stress	from enrolment until delivery

Trial Locations

Locations (7)

S.Orsola-Malpighi Hospital; 🇮🇹 Bologna, Italy

Divisione di Gastroenterologia, IRCCS Casa Sollievo della Sofferenza; 🇮🇹 San Giovanni Rotondo, Foggia, Italy

UOC Ostetricia e Ginecologia, Ospedale Maggiore; 🇮🇹 Bologna, Italy

Gastroenterology and Liver Clinic, Azienda Ospedaliero-Universitaria, University of Modena and Reggio Emilia; 🇮🇹 Modena, Italy

Gastroenterology Unit, Policlinic of Palermo; 🇮🇹 Palermo, Italy

Dept. of Surgical and Gastroenterological Sciences, University of Padova; 🇮🇹 Padua, Italy

Internal Medicine Department, Gemelli Hospital, Catholic University of Sacred Heart; 🇮🇹 Rome, Italy