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. |
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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. |
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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. |
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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. |