Tang 2003.
Methods | Randomisation by quote: "computer‐generated random numbers". Queen Mary Hospital, Hong Kong SAR, China. No information on study duration. |
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Participants | 80 women with non‐viable pregnancies diagnosed by ultrasound < 13 weeks. | |
Interventions | Group 1: 600 mcg misoprostol sublingually every 3 hours for maximum of 3 doses (n = 40); group 2: 600 mcg misoprostol vaginally every 3 hours for maximum of 3 doses (n = 40). Women discharged home after completion of treatment and reassessed day 7 ‐ when surgical evacuation performed if gestation sac still present, or retained POC plus heavy bleeding. | |
Outcomes | Primary outcome: complete miscarriage (defined as no need for surgical evacuation up until return of menstruation). | |
Funding | No information on funding. | |
Declarations of interest | No information on conflicts of interest. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Comment: computer‐generated random numbers. |
Allocation concealment (selection bias) | Unclear risk | Comment: no information on allocation concealment. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: outcomes were presented for all 80 patients that were initially randomised. |
Selective reporting (reporting bias) | Unclear risk | Comment: table 3 shows several side effects. The methods section states only that 'side effects' were measured without further specification. It is unclear if other side effects than the ones presented in table 3 were also measured. |
Other bias | Low risk | No other source of bias could be detected |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: no blinding of participants and personnel. Sublingual misoprostol was taken by the patient itself while vaginal misoprostol was administered by a research nurse. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: no information on blinding of outcome assessment. Probably not done. |