***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: BACKGROUND / AIMS The existence of impairment in bile acid transport across the placenta during intrahepatic cholestasis of pregnancy and the effect of ursodeoxycholic acid treatment ( 1 g/day ) were investigated . METHODS Kinetic parameters were calculated from experiments carried out on membrane vesicles obtained from basal ( TPMb , fetal-facing ) and apical ( TPMa , maternal-facing ) trophoblast plasma membranes . Bile acid uptake was measured using varying concentrations of [14C]-glycocholate and a rapid filtration technique . RESULTS The maximal velocity of transport ( Vmax ) , the apparent affinity constant ( Kt ) and the efficiency ( Ef ) of transport ( Vmax/Kt ) of the anion : bile acid exchanger located at the TPMb were reduced in intrahepatic cholestasis of pregnancy . Ursodeoxycholic acid induced a reversal of Vmax , Kt and Ef to normal values . Owing to the 3-fold increase in Vmax , with no change in Kt , intrahepatic cholestasis of pregnancy induced an enhancement in Ef of ATP-independent bile acid transport across TPMa . Both Vmax and Ef were restored to normal values by ursodeoxycholic acid . Finally , in ATP-dependent bile acid transport across TPMa , a reduction in the Ef due to an increase in Vmax together with a more pronounced increase in Kt was found . This impairment was also reversed by ursodeoxycholic acid . CONCLUSIONS These results suggest that placenta bile acid transport systems are impaired in intrahepatic cholestasis of pregnancy . Moreover , together with the confirmed beneficial effect for intrahepatic cholestasis of pregnancy patients , such as the relief of pruritus and the improvement in biochemical markers of cholestasis , ursodeoxycholic acid treatment restores the ability of the placenta to carry out vectorial bile acid transfer Intrahepatic cholestasis of pregnancy ( ICP ) is characterized by troublesome maternal pruritus , elevated serum bile acids ( ≥10 μmol/L ) and increased fetal risk . Recently we determined a cutoff level of serum bile acids , ≥40 μmol/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 r and omly 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 μmol/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 . BACKGROUND & AIMS Treatment of intrahepatic cholestasis of pregnancy with ursodeoxycholic acid appears promising , but data are limited so far . The aim of this r and omized study was to evaluate the efficacy and safety of ursodeoxycholic acid in comparison with cholestyramine . METHODS Eighty-four symptomatic patients with intrahepatic cholestasis of pregnancy were r and omized to receive either ursodeoxycholic acid , 8 - 10 mg/kg body weight daily ( n = 42 ) , or cholestyramine , 8 g daily ( n = 42 ) , for 14 days . The primary end point was a reduction of pruritus by more than 50 % after 14 days of treatment as evaluated by a pruritus score . Secondary end points were outcome of pregnancy , reduction of serum aminotransferase activities and serum bile acid levels , and drug safety . Intention-to-treat analysis was applied . RESULTS Pruritus was more effectively reduced by ursodeoxycholic acid than cholestyramine ( 66.6 % vs 19.0 % , respectively ; P < .005 ) . Babies were delivered significantly closer to term by patients treated with ursodeoxycholic acid than those treated with cholestyramine ( 38.7 + /- 1.7 vs 37.4 + /- 1.5 weeks , respectively , P < .05 ) . Serum alanine and aspartate aminotransferase activities were markedly reduced by 78.5 % and 73.8 % , respectively , after ursodeoxycholic acid , but by only 21.4 % , each , after cholestyramine therapy ( P < .01 vs ursodeoxycholic acid ) . Endogenous serum bile acid levels decreased by 59.5 % and 19.0 % , respectively ( P < .02 ) . Ursodeoxycholic acid , but not cholestyramine was free of adverse effects . CONCLUSIONS Ursodeoxycholic acid is safe and more effective than cholestyramine in intrahepatic cholestasis of pregnancy OBJECTIVE To test the efficacy and safety of ursodeoxycholic acid ( UDCA ) in the treatment of intrahepatic cholestasis of pregnancy ( ICP ) by a r and omized , double-blind , placebo-controlled trial . METHOD Eight patients with pruritus and abnormal liver function tests received 600 mg/day of UDCA  in two doses for 20 days , compared with a control group of eight patients who received placebo  for 20 days . RESULTS No adverse reactions were detected in any patient . During UDCA therapy a statistically significant improvement in pruritus , serum bile salt levels , serum glutamic pyruvic transaminase , alkaline phosphatase , gamma-glutamyl transpeptidase and total and direct bilirubin was observed . Only two patients treated with UDCA underwent cesarean sections due to reasons unrelated to the therapeutic trial . All newborns had an  Apgar score > 7 and normal postnatal growth . CONCLUSION Although the number of patients in this study was very small , we suggest that UDCA treatment has a role in improving clinical and biochemical results in ICP Objective To compare the efficacy of S‐adenosyl‐l‐methionine and ursodeoxycholic acid in improving serum biochemical abnormalities in gestational cholestasis The aim of this prospect i ve study was to analyze the characteristics of intrahepatic cholestasis of pregnancy ( ICP ) in a French population . From 1989 to 1995 we studied 50 consecutive pregnant women with ICP ( 41 single , 7 twin , and 2 triplet pregnancies ) referred for hepatologic consultation . All patients suffered from pruritus and /or jaundice associated with elevated fasting serum levels of total bile acids ( mean 49 micromol/L , range 7 - 290 ) . No patients had concomitant liver disease and all recovered normal liver function after delivery . Overall prematurity rate was 60 % : 100 % in multiple pregnancies and 41 % in single pregnancies . Three of 61 babies died . Systematic clinical interviews revealed that 34 patients had been treated with oral micronized natural progesterone ( 200 - 1,000 mg/d ) during the current pregnancy for risk of premature delivery , including at least 32 ( 64 % ) before the onset of pruritus . Onset of pruritus was statistically earlier in patients previously receiving progesterone than in patients not receiving progesterone ( 217 + /- 21 vs. 240 + /- 26 days , P < .01 ) . This was also found in the single pregnancy subgroup of patients ( 222 + /- 19 vs. 240 + /- 26 days , P < .05 ) . Pruritus disappeared before delivery in 10 of 50 patients , i.e. , after withdrawal of progesterone in 7 patients ( only one concurrently treated with cholestyramine ) , after decrease in dose of progesterone in 1 patient , and spontaneously in 2 patients . During the same period , the percentage of pregnant women without ICP who had been treated with progesterone during pregnancy was statistically lower than the percentage of patients treated with progesterone before the onset of pruritus in our group of patients with ICP ( 36 % vs. 64 % , P < .01 , odds ratio 3.16 , 95 % CI:1.29 - 7.80 ) . These results suggest that orally administered progesterone might be an exogenous factor which triggers ICP in predisposed women Background Obstetric cholestasis ( OC ) is a serious problem in pregnancy . It affects about 4500 women per year in the UK . Affected women develop itching and occasionally jaundice . More importantly , the condition is associated with premature delivery , fetal distress and is believed to be an important cause of stillbirth . However , even now , there is no clear evidence as to whether the most popular treatment , a drug called ursodeoxycholic acid is beneficial to the baby , or even if it is safe in pregnancy . Nor do we know whether planned early delivery of the baby at 37–38 weeks , another popular treatment , does more good than harm . A r and omised trial to evaluate both  ursodeoxycholic acid  and timed delivery is needed but will be complicated and expensive . We plan a preliminary study , Pilot study for a trial of ursodeoxycholic acid and /or early delivery for obstetric cholestasis ( Acronym PITCH- Pregnancy Intervention Trial in Cholestasis ) trial , to evaluate the feasibility of a larger trial . The trial is funded by the NHS Research for Patient Benefit ( RfPB ) Programme . Methods PITCH is a multi-centre , double blinded , r and omised , controlled , factorial design trial . The trial is being run in six UK centres and women with obstetric cholestasis will be recruited for eighteen months . In this pilot trial we aim to collect data to finalise the design for the main trial . This will include measuring trial recruitment rate , including recruitment to each factorial comparison separately . We will also measure the spectrum of disease among recruits and non-recruits and compliance with the four possible treatment allocations . We will use these data to design the main trial . Discussion The ultimate aim of the main trial is to enable clinicians to manage this condition more effectively . If it transpires that ursodeoxycholic acid and early delivery are both safe and effective then steps will be taken to ensure that all women with OC who could benefit from them receives this treatment . Conversely , if one or both the treatments turn out to be ineffective or even harmful , they will be stopped and research ers will work at developing other modes of treatment . Trial registration numberIS RCT BACKGROUND / AIMS Intense pruritus and the risk of stillbirths and premature deliveries justify the search for an effective pharmacologic treatment of intrahepatic cholestasis of pregnancy . This study was design ed to test the efficacy of ursodeoxycholic acid in maternal pruritus , the biochemical abnormalities and the outcome of pregnancy , in patients with intrahepatic cholestasis of pregnancy of early onset . METHODS Pregnant patients hospitalized in a secondary case-referral center with intense pruritus and abnormal serum levels of bile salts and aminotransferases , detected before week 33 of pregnancy , were r and omly assigned to receive ursodeoxycholic acid , 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 patients entered the trial ; eight had deliveries before 2 weeks of treatment and one dropped out . The study was then completed in 15 patients : eight received ursodeoxycholic acid and seven placebo . No adverse effects were detected in the mothers or in their babies . After 3 weeks of treatment , patients receiving ursodeoxycholic acid ( mean daily dose 16 mg/kg body weight ) had a significant improvement in pruritus ( p<0.02 ) , in serum bilirubin ( 0.36+/-0.19 mg/dl ( mean+/-SD ) versus 0.95+/-0.48 in patients receiving placebo , p<0.01 ) , in aspartate 
    Output:
    
Based on a meta- analysis , UDCA is effective in reducing pruritus and improving liver test results in patients with ICP ;  UDCA therapy might also benefit fetal outcomes