Luo 2008.
Methods | Randomised controlled trial. | |
Participants | 64 women randomised. Setting: Affiliated Hospital of Hanzhou Normal University, Hanzhou, China. Recruitment: June 2002‐July 2007. Inclusion criteria: neonatal jaundice and/or maternal? itching, rise in the levels of serum transaminase and CG. Exclusion criteria: any skin infection, prolonged liver disease, any other illnesses, high blood pressure, received other forms of treatment for ICP. |
|
Interventions |
Transmetil + UDCA (n = 34). Transmetil (1 g + 5% Glucose 250 mL IV OD) + UDCA (250 mg Oral pill BD) for 10 days. UDCA (n = 30). UDCA 250 mg BD for 10 days. Patients took dexamethasone (10 mg OD) for 3 days before the treatment in both groups. |
|
Outcomes |
Maternal: scale of itchiness (0‐4 Ribalta scale); levels of ALT, AST, total bile acids, amount of haemoglobin, CS rate. Fetal/neonatal: preterm birth, clearness of amniotic fluid (i.e. number of cases where the fluid was not clear), Apgar score, birthweight. |
|
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "randomly assigned" ‐ no further details reported. |
Allocation concealment (selection bias) | Unclear risk | "randomly assigned" ‐ no further details reported. |
Blinding (performance bias and detection bias) All outcomes | High risk | The route of administration of interventions in the 2 groups were different and therefore blinding would not have been possible. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No losses to follow‐up or withdrawal in either group. |
Selective reporting (reporting bias) | Unclear risk | Not all expected outcomes reported. |
Other bias | Low risk | According to the translation, “Their traits and characteristics were not significantly different from each other". |