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Ursodeoxycholic acid in the treatment of intrahepatic cholestasis of pregnancy: a randomized controlled trial

  • Maternal-Fetal Medicine
  • Published:
Archives of Gynecology and Obstetrics Aims and scope Submit manuscript

Abstract

Purpose

To test the efficacy and safety of ursodeoxycholic acid (UDCA) in the treatment of patients with intrahepatic cholestasis of pregnancy (ICP).

Methods

In the randomized (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 and itching scores were assessed before the treatment and weekly thereafter. The effects of UDCA on liver function and fetoplacental hormone production were measured with covering laboratory testing: serum levels of alanine aminotransferase (ALAT), total bile acids (TBA), estradiol, progesterone, prolactin, cholesterol, HDL-cholesterol, triglycerides, activated partial thromboplastin time, fibrinogen d-dimers (FIDD) and platelet count were assessed before the treatment and weekly thereafter. Data on pregnancy and delivery outcome were recorded and analyzed.

Results

UDCA was well tolerated. A significant improvement in itching scores was detected in 2 weeks in the group receiving UDCA. Serum levels of ALAT and TBA fell after 2 weeks treatment. The other laboratory values were not modified by the treatment.

Conclusions

UDCA improves maternal itching scores and liver function tests without interfering with the fetoplacental estrogen production in patients with ICP. UDCA is well tolerated by pregnant women. No fetal or neonatal side-effects could be detected.

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Abbreviations

UDCA:

Ursodeoxycholic acid

ICP:

Intrahepatic cholestasis of pregnancy

APTT:

Activated partial thromboplastin time

FIDD:

Fibrinogen d-dimers

VAS:

Visual analogue scale

ALAT:

Plasma alanine aminotransferase

TBA:

Total bile acid

GA:

Gestational age

UA pH:

Umbilical artery pH

RDS:

Respiratory distress syndrome

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Authors and Affiliations

  1. Department of Obstetrics and Gynecology, Turku University Central Hospital, Kiinamyllynkatu 4-8, 20520, Turku, Finland

    Titta Joutsiniemi, Susanna Timonen, Riitta Leino, Pertti Palo & Ulla Ekblad

Authors
  1. Titta Joutsiniemi
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  2. Susanna Timonen
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  3. Riitta Leino
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  4. Pertti Palo
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  5. Ulla Ekblad
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Corresponding author

Correspondence to Titta Joutsiniemi.

Additional information

Clinical Trials.gov Identifier NCT01576458.

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Joutsiniemi, T., Timonen, S., Leino, R. et al. Ursodeoxycholic acid in the treatment of intrahepatic cholestasis of pregnancy: a randomized controlled trial. Arch Gynecol Obstet 289, 541–547 (2014). https://doi.org/10.1007/s00404-013-2995-5

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  • DOI: https://doi.org/10.1007/s00404-013-2995-5

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