Clinical Trial: Ursodeoxycholic Acid And Cholestasis Of Pregnancy
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: Intrahepatic Cholestasis Of Pregnancy: Clinical Impact Of Ursodeoxycholic Acid Treatment
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 Summary:
Sponsor: University of Bologna
Current Primary Outcome: Number of participants with preterm delivery (before week 37) [ Time Frame: at the time of delivery ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Pruritus on the Visual Analogue Scale [ Time Frame: from enrollment until delivery ]
- Transaminases [ Time Frame: from enrolment until delivery ]
- Bile Acids [ Time Frame: from enrolment until delivery ]
- Fetal movement count [ Time Frame: from enrolment until delivery ]mother evaluation
- Number of pregnancies with cardiotocography suggestive of fetal stress [ Time Frame: from enrolment until delivery ]
- APGAR index [ Time Frame: 1 and 5 minutes after birth ]
- Number of pregnancies with Green stained amniotic fluid [ Time Frame: at delivery ]obstetrician evaluation
Original Secondary Outcome: Same as current
Information By: University of Bologna
Dates:
Date Received: October 19, 2010
Date Started: November 2010
Date Completion: November 2013
Last Updated: May 10, 2016
Last Verified: May 2016
