BACKGROUND/AIMS: Intense @entity111 and the risk of @entity2209 and premature deliveries justify the search for an effective pharmacologic treatment of @entity9744 of pregnancy. This study was designed to test the efficacy of @entity10055 in maternal @entity111 , the biochemical abnormalities and the outcome of pregnancy, in @entity1 with @entity13359 . METHODS: Pregnant @entity1 hospitalized in a secondary case-referral center with intense @entity111 and abnormal serum levels of @entity3645 and aminotransferases, detected before week 33 of pregnancy, were randomly assigned to receive @entity10055 , 1 g per day orally, or an identical placebo, until delivery, in a double-blind study. A 3-week trial period was chosen to compare drug and placebo effects. The follow-up was extended for 3 months after delivery. RESULTS: Twenty-four @entity1 entered the trial; eight had deliveries before 2 weeks of treatment and one dropped out. The study was then completed in 15 @entity1 : eight received @entity10055 and seven placebo. No adverse effects were detected in the mothers or in their babies. After 3 weeks of treatment, @entity1 receiving @entity10055 (mean daily dose 16 mg/kg body weight) had a significant improvement in @entity111 (p<0.02), in serum @entity648 (0.36+/-0.19 mg/dl (mean+/-SD) versus 0.95+/-0.48 in @entity1 receiving placebo, p<0.01), in @entity492 aminotransferase (52+/-42 IU/l vs 98+/-44, p<0.05) and in @entity493 aminotransferase (54+/-50 IU/l vs 229+/-154, p<0.01); serum total @entity3645 also tended to be lower in @entity1 receiving @entity10055 (26.3+/-33.7 micromol/l vs 55.0+/-44.8, p N.S.). Deliveries occurred at or near term in all mothers who received @entity10055 (mean week of pregnancy: 38), while they occurred before week 36 of pregnancy in five @entity1 who received placebo, including one @entity2209 . All babies born alive had birth weights adequate for gestational age and they were thriving normally 3 months after delivery. CONCLUSIONS: @entity10055 is effective and safe in @entity1 with @entity13359 , attenuating @entity111 and correcting some biochemical abnormalities in the mothers. Relevant aspects of fetal outcome were also improved in @entity1 receiving @entity10055 compared to placebo.

XXXX in the treatment of cholestasis of pregnancy: a randomized, double-blind study controlled with placebo.

@entity1 :: ('9606', 'Species') :: ['patients'] @entity13359 :: ('MESH:C535932', 'Disease') :: ['intrahepatic cholestasis of pregnancy of early onset'] @entity2209 :: ('MESH:D050497', 'Disease') :: ['stillbirth', 'stillbirths'] @entity648 :: ('MESH:D001663', 'Chemical') :: ['bilirubin'] @entity111 :: ('MESH:D011537', 'Disease') :: ['pruritus'] @entity492 :: ('CHEBI:29995', 'Chemical') :: ['aspartate'] @entity493 :: ('CHEBI:16449', 'Chemical') :: ['alanine'] @entity3645 :: ('MESH:D001647', 'Chemical') :: ['bile salts'] @entity9744 :: ('MESH:D002780', 'Disease') :: ['intrahepatic cholestasis'] @entity10055 :: ('MESH:D014580', 'Chemical') :: ['Ursodeoxycholic acid', 'ursodeoxycholic acid']
@entity10055 :: (MESH:D014580,Chemical) :: ['Ursodeoxycholic acid']
