Ursodeoxycholic Acid in the Treatment of Intrahepatic Cholestasis of Pregnancy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Titta Joutsiniemi, Turku University Hospital
ClinicalTrials.gov Identifier:
NCT01576458
First received: February 18, 2012
Last updated: April 11, 2012
Last verified: April 2012

February 18, 2012
April 11, 2012
January 1998
December 1998   (final data collection date for primary outcome measure)
  • pruritus [ Time Frame: an average of 5 weeks ] [ Designated as safety issue: Yes ]
    visual analogy scale (VAS): 0-10
  • laboratory values [ Time Frame: an average 5 weeks ] [ Designated as safety issue: Yes ]
    Serum levels of alanine aminotransferases and total bile acids were assessed before the treatment and once a week thereafter at least three times or until delivery. Simultaneously serum levels of estradiol, progesterone, prolactin, cholesterol, HDL-cholesterol and triglyserides were assessed. Platelet count activated partial thromboplastin time and fibrinogen D-dimers were measured as well.
Same as current
Complete list of historical versions of study NCT01576458 on ClinicalTrials.gov Archive Site
Obstetrical surveillance [ Time Frame: 2-12 weeks ] [ Designated as safety issue: Yes ]
Data on pregnancy and delivery outcome was recorded and analysed.
Same as current
Not Provided
Not Provided
 
Ursodeoxycholic Acid in the Treatment of Intrahepatic Cholestasis of Pregnancy
Randomised Placebo-controlled Study of Ursodeoxycholic Acid in the Treatment of Intrahepatic Cholestasis of Pregnancy

The purpose of this study is to examine the efficacy and safety of ursodeoxycholic acid (UDCA) in the treatment of patients with intrahepatic cholestasis of pregnancy (ICP).

In the randomised (double-blind, placebo-controlled) study 20 pregnant women with ICP received (random allocation of) either 450 mg/day UDCA or placebo for 14 days during the third trimester of pregnancy. The severity of pruritus was registered. Itching scores and serum levels of alanine aminotransferase, total bile acids, estradiol, progesterone, prolactin, cholesterol, HDL-cholesterol, triglycerides, activated partial thromboplastin time (APTT), fibrinogen D-dimers (FIDD) and platelet count were assessed before the treatment and weekly thereafter. Data on pregnancy and delivery outcome was recorded and analysed.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Intrahepatic Cholestasis
  • Pregnancy
  • Drug: ursodeoxycholic acid
    450 mg/day for 14 days
  • Drug: Placebo
    placebo
    Other Name: placebo
  • Active Comparator: ursodeoxycholic acid
    10 pregant women with intrahepatic cholestasis of pregnancy
    Intervention: Drug: ursodeoxycholic acid
  • Active Comparator: placebo
    10 pregnant women with intrahepatic cholestasis of pregnancy
    Intervention: Drug: Placebo
Joutsiniemi T, Timonen S, Leino R, Palo P, Ekblad U. Ursodeoxycholic acid in the treatment of intrahepatic cholestasis of pregnancy: a randomized controlled trial. Arch Gynecol Obstet. 2014 Mar;289(3):541-7. doi: 10.1007/s00404-013-2995-5. Epub 2013 Aug 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
December 1998
December 1998   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Pregnant women with intrahepatic cholestasis of pregnancy
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT01576458
73/180/2011, 73/180/2011
Yes
Titta Joutsiniemi, Turku University Hospital
Turku University Hospital
Not Provided
Study Chair: Susanna Timonen, PhD Turku University Hospital
Study Director: Ulla Ekblad, PhD Turku University Hospital
Principal Investigator: Riitta Leino, MD Turku University Hospital
Principal Investigator: Pertti Palo, PhD Turku University Hospital
Turku University Hospital
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP