A prospective study of 18 patients with cholestasis of pregnancy

Shaw, Dorothy; Frohlich, Jiri; Wittman, Bernd; Willms, M.

doi:10.1016/s0002-9378(16)32430-9

Cited by 131 publications

(120 citation statements)

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“…[2][3][4][5][6][7][8][9] This double-blind, placebo-controlled study was designed to compare the effects of UDCA and dexamethasone on fetal outcome, biochemical markers of cholestasis, and maternal pruritus in women diagnosed with ICP. Based on an ITT analysis, the only observed significant effects of any treatment were UDCA-induced reductions of serum bilirubin and ALT levels.…”

Section: Discussionmentioning

confidence: 99%

“…It is noteworthy that even if 240 women had been included, it would have been insufficient to reveal treatment effects on fetal outcome because the overall number of fetal complications was substantially lower in our ICP study population than in any previous report. [2][3][4][5][6][7][8][9][10] However, because the observational part of our ICP study recently demonstrated that fetal complication rates do not increase until bile acid levels exceed 40 mol/L, 10 the subgroup of women presenting with bile acid levels Ն40 mol/L at randomization was analyzed separately. This subgroup analysis revealed that treatment with UDCA actually improved all biochemical markers of cholestasis as well as pruritus, and that treatment with UDCA was more effective than treatment with dexamethasone or placebo.…”

Section: Discussionmentioning

confidence: 99%

“…[2][3][4][5][6][7][8][9] Based on a possible drug-related reduction of the fetal complication rate by 33%, a significance level of 0.05, a two-tailed analysis, and a power of 80%, 240 patients (80 in each arm) were needed to treat.…”

Section: Methodsmentioning

confidence: 99%

“…Family clustering and varying incidence in different geographic regions suggest an underlying genetic explanation. 1 Although essentially benign from a maternal viewpoint, ICP is associated with increased fetal risks, such as preterm delivery in 19% to 60%, [2][3][4] fetal distress in 22%-41%, 3,[5][6][7][8] and intrauterine fetal death in 1% to 4% of affected pregnancies. 3,6,9 Fetal complication rates are related to maternal serum bile acid levels, and increase when bile acid levels exceed 40 mol/L.…”

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confidence: 99%

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Intrahepatic cholestasis of pregnancy

Glantz¹,

Marschall²,

Lammert³

et al. 2005

Hepatology

234

143

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Intrahepatic cholestasis of pregnancy (ICP) is characterized by troublesome maternal pruritus, elevated serum bile acids (>10 mol/L) and increased fetal risk. Recently we determined a cutoff level of serum bile acids, >40 mol/L, to be associated with impaired fetal outcome. We have now studied the effects of ursodeoxycholic acid (UDCA) and dexamethasone on pruritus, biochemical markers of cholestasis, and fetal complication rates in a double-blind, placebo-controlled trial. For this purpose, 130 women with ICP were randomly allocated to UDCA (1 g/day for three weeks), or dexamethasone (12 mg/day for 1 week and placebo during weeks 2 and 3), or placebo for 3 weeks. Pruritus and biochemical markers of cholestasis were analyzed at inclusion and after 3 weeks of treatment. Fetal complications (spontaneous preterm delivery; asphyxial events; and meconium staining of amniotic fluid, placenta, and membranes) were registered at delivery. An intention-to-treat analysis showed significant reduction of alanine aminotransferase (ALT) (P ‫؍‬ .01) and bilirubin (P ‫؍‬ .002) in the UDCA group only. In a subgroup analysis of ICP women with serum bile acids >40 mol/L at inclusion (n ‫؍‬ 34), UDCA had significant effects on pruritus (؊75%), bile acids (؊79%), ALT (؊80%), and bilirubin (؊50%) as well, but not on fetal complication rates. Dexamethasone yielded no alleviation of pruritus or reduction of ALT and was less effective than UDCA at reducing bile acids and bilirubin. In conclusion, 3 weeks of UDCA treatment improved some biochemical markers of ICP irrespective of disease severity, whereas significant relief from pruritus and marked reduction of serum bile acids were only found in patients with severe ICP. (HEPATOLOGY 2005;42:1399-1405

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

mentioning

confidence: 99%

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Intrahepatic cholestasis of pregnancy

Glantz¹,

Marschall²,

Lammert³

et al. 2005

Hepatology

234

143

View full text Add to dashboard Cite

show abstract

“…Intrahepatitic cholestasis of pregnancy (ICP), also called obstetric cholestasis, is a specific liver disease that takes place in the second or third trimester of gestation and spontaneously disappears after delivery (Shaw et al, 1982;. Firstly reported by Ahfiled in 1883, it was after 1950 that the disease began to be considered of significance when several clinical cases were studied.…”

Section: Introductionmentioning

confidence: 99%