Methods | RCT with randomisation of individual women. | |
Participants | Inclusion criteria
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Interventions | Intervention: vaginal misoprostol.
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Outcomes | Efficacy; side effects; short-term complications.
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Notes |
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Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer-generated set of random numbers in blocks of 5. |
Allocation concealment (selection bias) | Low risk | Opaque envelopes labelled serially. |
Blinding (performance bias and detection bias) All outcomes |
Unclear risk | No information given. |
Incomplete outcome data (attrition bias) All outcomes |
High risk | Of the 201 women randomised, 198 got the treatment allocated, but only 186 were analysed because 12 were lost to follow up - 7.5%. It is unclear whether ITT analysis was undertaken |
Selective reporting (reporting bias) | Unclear risk | No obvious outcome reporting bias but authors do not list their outcomes and although only report significant differences in abstract, in paper they report several adverse outcomes with data. We did not assess the trial protocol. |
Other bias | Low risk | Significantly more women in oral group had a past history of termination, P < 0. 001, but this was thought to probably not to create important bias |