Ursodeoxycholic Acid in the Treatment of Intrahepatic Cholestasis of Pregnancy
NCT ID: NCT01576458
Last Updated: 2012-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
20 participants
INTERVENTIONAL
1998-01-31
1998-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ursodeoxycholic acid
10 pregant women with intrahepatic cholestasis of pregnancy
ursodeoxycholic acid
450 mg/day for 14 days
placebo
10 pregnant women with intrahepatic cholestasis of pregnancy
Placebo
placebo
Interventions
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ursodeoxycholic acid
450 mg/day for 14 days
Placebo
placebo
Eligibility Criteria
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Inclusion Criteria
FEMALE
No
Sponsors
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Turku University Hospital
OTHER_GOV
Responsible Party
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Titta Joutsiniemi
MD
Principal Investigators
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Susanna Timonen, PhD
Role: STUDY_CHAIR
Turku University Hospital
Ulla Ekblad, PhD
Role: STUDY_DIRECTOR
Turku University Hospital
Riitta Leino, MD
Role: PRINCIPAL_INVESTIGATOR
Turku University Hospital
Pertti Palo, PhD
Role: PRINCIPAL_INVESTIGATOR
Turku University Hospital
Locations
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Turku University Hospital
Turku, , Finland
Countries
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References
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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.
Other Identifiers
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73/180/2011
Identifier Type: REGISTRY
Identifier Source: secondary_id
73/180/2011
Identifier Type: -
Identifier Source: org_study_id
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