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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01576458

Enrollment

Registered

2012-04-12

Start date

1998-01-31

Completion date

1998-12-31

Last updated

2012-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intrahepatic Cholestasis, Pregnancy

Keywords

ursodeoxycholic acid, intrahepatic cholestasis, 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.

Interventions

DRUGursodeoxycholic acid

450 mg/day for 14 days

DRUGPlacebo

placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Inclusion criteria

* Pregnant women with intrahepatic cholestasis of pregnancy

Design outcomes

Primary

Measure	Time frame	Description
pruritus	an average of 5 weeks	visual analogy scale (VAS): 0-10
laboratory values	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.

Secondary

Measure	Time frame	Description
Obstetrical surveillance	2-12 weeks	Data on pregnancy and delivery outcome was recorded and analysed.

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026