Fang 2009.
Methods | Quasi‐randomised controlled trial. | |
Participants | 128 women randomised. Setting: First Affiliated Hospital of Xi’an Jiaotong University (Obstetrics Department) Inclusion criteria: women with singleton pregnancy presenting with antepartum itching and abnormal ALT and AST which resolved postpartum. Exclusion criteria: antenatal problems such as vomiting, loss of appetite, lethargy or any medical problems, known liver disease or hepatitis prior to pregnancy. |
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Interventions |
Salvia+UDCA (N = 72). Salvia injection IV (10 mL in 10% 500 mL Dextrose) and UDCA 15 mg TDS PO for 14 days. UDCA (N = 56). UDCA 15 mg TDS PO for 14 days. |
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Outcomes |
Maternal: reduction in pruritus score; monitoring of CG, TB, ALT and AST levels. Fetal/neonatal: CS for fetal distress; meconium‐stained liquor; Apgar score and birthweight. |
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Notes | Article in Chinese. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Quasi‐randomised controlled trial. "A total of 128 patients were divided into two groups based on the date of admission into the First Affiliated Hospital of Xi'An Jiaotong University." |
Allocation concealment (selection bias) | High risk | Quasi‐randomised controlled trial. "A total of 128 patients were divided into two groups based on the date of admission into the First Affiliated Hospital of Xi'An Jiaotong University." |
Blinding (performance bias and detection bias) All outcomes | High risk | The route of administration of the interventions being compared were different and therefore blinding would not have been possible. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | There appear to be no losses to follow‐up. |
Selective reporting (reporting bias) | Unclear risk | Results for outcomes described in the abstract and methods are reported. However, stillbirth, neonatal death or preterm birth are not reported. |
Other bias | Unclear risk | It is unclear why there are 72 women in the experimental group and 58 women in the control group. |