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. 2013 Jun 24;2013(6):CD000493. doi: 10.1002/14651858.CD000493.pub2

Liu 2006.

Methods Randomised controlled trial.
Participants 68 women randomised.
Setting: Wuhan, China.
Recruitment: June 2001‐July 2003.
Inclusion criteria: women at 25 ‐ 37 weeks' gestation with severe gestational pruritus; serum total bile acids > 10 μmol/L and raised ALT or conjugated bilirubin.
Exclusion criteria: other known causes of liver dysfunction.
Interventions UDCA (n = 34).
300 mg (18 mg/kg body weight) 3 times a day for 2 weeks.
Placebo (n = 34).
Combination of 10% glucose, vitamin C and inosine for 2 weeks. They were kept on a low‐fat diet and bed rest during the period of the study.
Outcomes Maternal: pruritus score, mode of birth, adverse effects, LFTs, total bile acids
Pruritus score was self‐assessed every 3 days on a VAs: 0 = no pruritus; 1 = occasional; 2 = intermittent pruritus everyday with asymptomatic periods prevailing; 3 = intermittent pruritus everyday with preponderance of symptomatic periods; 4 = constant pruritus.
However results were only reported as a number +‐ another number. Because it is not clear if these were means or medians, and if the +‐ was SD, SE or other measure of dispersion, these results are not analysable.
Fetal/neonatal: antepartum testing prompting delivery; gestation at birth; passage of meconium; intrapartum fetal distress; Apgar scores at 1 and 5 minutes; birthweight, adverse events.
Notes Fetal asphyxia was not defined.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Participants were "divided into treatment group and control group at random". No further details.
Allocation concealment (selection bias) Unclear risk Not described.
Blinding (performance bias and detection bias) 
 All outcomes Unclear risk It is unclear whether the clinicians/investigators and the participants were blinded to trial allocation.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk There was no trial flow diagram. The trial was not registered. Follow‐up rates were not reported.
Selective reporting (reporting bias) High risk Stillbirths and neonatal deaths were not reported.
Apgar scores, and adverse events were recorded but not reported.
Other bias Low risk No other additional bias noted.