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.
Drug: ursodeoxycholic acid
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Randomised Placebo-controlled Study of Ursodeoxycholic Acid in the Treatment of Intrahepatic Cholestasis of Pregnancy|
- 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.
- Obstetrical surveillance [ Time Frame: 2-12 weeks ] [ Designated as safety issue: Yes ]Data on pregnancy and delivery outcome was recorded and analysed.
|Study Start Date:||January 1998|
|Study Completion Date:||December 1998|
|Primary Completion Date:||December 1998 (Final data collection date for primary outcome measure)|
Active Comparator: ursodeoxycholic acid
10 pregant women with intrahepatic cholestasis of pregnancy
Drug: ursodeoxycholic acid
450 mg/day for 14 days
Active Comparator: placebo
10 pregnant women with intrahepatic cholestasis of pregnancy
Other Name: placebo
Please refer to this study by its ClinicalTrials.gov identifier: NCT01576458
|Turku University Hospital|
|Turku, Finland, 20520|
|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|