Ursodeoxycholic Acid in the Treatment of Intrahepatic Cholestasis of Pregnancy

Turku University Hospital (TYKS)

Status and phase: Completed; Phase 3

Conditions: Intrahepatic Cholestasis; Pregnancy

Treatments: Drug: Placebo; Drug: ursodeoxycholic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT01576458

73/180/2011 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Pregnant women with intrahepatic cholestasis of pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

ursodeoxycholic acid

Active Comparator group

Description:

10 pregant women with intrahepatic cholestasis of pregnancy

Treatment:

Drug: ursodeoxycholic acid

placebo

Active Comparator group

Description:

10 pregnant women with intrahepatic cholestasis of pregnancy

Treatment:

Drug: Placebo