Kaaja 1994.
Methods | Randomised controlled trial. | |
Participants | 19 women randomised (1 woman entered trial in 2 successive pregnancies). Setting: Helsinki, Finland. Inclusion criteria: women with pruritus and abnormalities of liver function. Exclusion criteria: hepatitis A and B, gallbladder pathology. |
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Interventions |
Activated charcoal (n = 10). Activated charcoal as a water suspension, 50 g 3 times a day for 8 days. vs No treatment (n = 10). Normal follow‐up of ICP with no charcoal administration. Participants maintained a daily record of pruritus: 0 = no itching; 1 = mild itching; 2 = moderate itching, does not disturb sleep; 3 = intense itching, disturbs sleep; 4 = very intense (intolerable) itching, forces participant to scratch continuously. Fasting blood samples were collected for total bile acids and LFTs at the start of the study and were repeated on day 4 and 8. |
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Outcomes |
Maternal: status of pruritus; assays of liver function and bile acids. Fetal/neonatal: gestation at delivery, birthweight. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described. |
Allocation concealment (selection bias) | Unclear risk | Not described. |
Blinding (performance bias and detection bias) All outcomes | High risk | Open trial. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No losses to follow‐up reported. |
Selective reporting (reporting bias) | High risk | Few fetal/neonatal outcomes not reported. |
Other bias | Low risk | No other additional bias noted. |