Methods | RCT with randomisation of individual women. | |
Participants | Inclusion criteria
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Interventions | Intervention: vaginal misoprostol.
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Outcomes | Number of days of vaginal bleeding; rate of complications (fall in Hb, infection, perforation) and women’s satisfaction
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Notes |
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Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No information provided except to say women were randomised. |
Allocation concealment (selection bias) | Unclear risk | No information provided. |
Blinding (performance bias and detection bias) All outcomes |
High risk | Participants nor clinicians cannot be blinded. There is nomention as to whether the outcome assessor was blinded. For outcomes where participants assessed for themselves, these were not blinded |
Incomplete outcome data (attrition bias) All outcomes |
Low risk | No losses and no exclusions were reported, but nothing is described. As there is no deviation from protocol it is assumed that analysis was by ITT |
Selective reporting (reporting bias) | Unclear risk | Seem to report on all outcomes specified in ‘Materials and methods’ but we did not assess the trial protocol |
Other bias | Unclear risk | No imbalances in baseline data identified (assessed: age, gravity, parity, gestational age, anterior-posterior diameter). Study not stopped early and no apparent differential diagnosis |