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Ursodeoxycholic Acid in the Treatment of Intrahepatic Cholestasis of Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01576458
Recruitment Status : Completed
First Posted : April 12, 2012
Last Update Posted : April 12, 2012
Sponsor:
Information provided by (Responsible Party):
Titta Joutsiniemi, Turku University Hospital

Tracking Information
First Submitted Date  ICMJE February 18, 2012
First Posted Date  ICMJE April 12, 2012
Last Update Posted Date April 12, 2012
Study Start Date  ICMJE January 1998
Actual Primary Completion Date December 1998   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2012)
  • pruritus [ Time Frame: an average of 5 weeks ]
    visual analogy scale (VAS): 0-10
  • laboratory values [ Time Frame: an average 5 weeks ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2012)
Obstetrical surveillance [ Time Frame: 2-12 weeks ]
Data on pregnancy and delivery outcome was recorded and analysed.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ursodeoxycholic Acid in the Treatment of Intrahepatic Cholestasis of Pregnancy
Official Title  ICMJE Randomised Placebo-controlled Study of Ursodeoxycholic Acid in the Treatment of Intrahepatic Cholestasis of Pregnancy
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Intrahepatic Cholestasis
  • Pregnancy
Intervention  ICMJE
  • Drug: ursodeoxycholic acid
    450 mg/day for 14 days
  • Drug: Placebo
    placebo
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 11, 2012)
20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 1998
Actual Primary Completion Date December 1998   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Pregnant women with intrahepatic cholestasis of pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01576458
Other Study ID Numbers  ICMJE 73/180/2011
73/180/2011 ( Registry Identifier: URSODEOXYCHOLIC ACID AND INTRAHEPATIC CHOLESTASIS OF PREGNANCY )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Titta Joutsiniemi, Turku University Hospital
Study Sponsor  ICMJE Turku University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Turku University Hospital
Verification Date April 2012

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