Kovavisarach 2002.
Methods | Quote: "Random allocation". Method not discussed. Between 1 July 1998 and 31 January 1999 at the gynaecologic clinic at Rajavithi Hospital, Bangkok, Thailand. |
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Participants | 54 women with anembryonic pregnancies < 12 weeks diagnosed by TVS. Single centre study in Bangkok, Thailand. | |
Interventions | Vaginal misoprostol 400 mcg (n = 27) or placebo (n = 27). Reviewed after 24 hours and curettage offered if no or incomplete miscarriage. Further review after 1 week. | |
Outcomes | Primary: complete miscarriage within 24 hours of treatment. | |
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) | Unclear risk | Quote: "Patients were randomly allocated". Comment: method not discussed. |
Allocation concealment (selection bias) | Unclear risk | Comment: no information on allocation concealment. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: 54 women were recruited in the study, for all of them outcomes were reported. |
Selective reporting (reporting bias) | Unclear risk | Comment: in the results section several side effects (nausea, pain) are reported that were not mentioned in the methods section; unclear if these were the only side effects that were measured. |
Other bias | Low risk | No other source of bias could be detected |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: no information on blinding of patients and personnel. Sinces patients received either misoprostol or placebo it is likely that they were blinded. Blinding of personnel that might recognise misoprostol if the placebo tablets had another shape remains unclear. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: there is no information on blinding of outcome assessment. Considering that placebo was used as comparison there might have been blinding of the outcome assessor, assuming this was not the person providing the medication (and thus capable of recognising a placebo if it had another shape than the misoprostol). |