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| ID | Type | Description | Link |
|---|---|---|---|
| 73/180/2011 | Registry Identifier | URSODEOXYCHOLIC ACID AND INTRAHEPATIC CHOLESTASIS OF PREGNANCY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ursodeoxycholic acid | Active Comparator | 10 pregant women with intrahepatic cholestasis of pregnancy |
|
| placebo | Active Comparator | 10 pregnant women with intrahepatic cholestasis of pregnancy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ursodeoxycholic acid | Drug | 450 mg/day for 14 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| pruritus | visual analogy scale (VAS): 0-10 | an average of 5 weeks |
| laboratory values | 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. | an average 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Obstetrical surveillance | Data on pregnancy and delivery outcome was recorded and analysed. | 2-12 weeks |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susanna Timonen, PhD | Turku University Hospital | Study Chair |
| Ulla Ekblad, PhD | Turku University Hospital | Study Director |
| Riitta Leino, MD | Turku University Hospital | Principal Investigator |
| Pertti Palo, PhD | Turku University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Turku University Hospital | Turku | 20520 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23978872 | Derived | 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. |
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| ID | Term |
|---|---|
| D002780 | Cholestasis, Intrahepatic |
| ID | Term |
|---|---|
| D002779 | Cholestasis |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D014580 | Ursodeoxycholic Acid |
| ID | Term |
|---|---|
| D003840 | Deoxycholic Acid |
| D002793 | Cholic Acids |
| D001647 | Bile Acids and Salts |
| D013256 | Steroids |
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| Placebo |
| Drug |
placebo |
|
| D008107 |
| Liver Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002757 | Cholanes |