Methods | RCT with randomisation of individual women in ratio of 3:1. | |
Participants | Inclusion criteria
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Interventions | Intervention: vaginal misoprostol.
Comparison: surgery.
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Outcomes | Success, Hb, fever, nausea, vomiting, diarrhoea and acceptability
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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 | “…centralised, computer-automated telephone response system…” used to ran-domly assign women to groups in a 3:1 ratio |
Allocation concealment (selection bias) | Low risk | A centralised, computer-automated telephone response system. It was considered that because it was an automated computer response, then allocation concealment would be good |
Blinding (performance bias and detection bias) All outcomes |
High risk | Not possible to blind either women or clinicians. |
Incomplete outcome data (attrition bias) All outcomes |
Low risk | 1 woman lost to follow up - surgical group. |
Selective reporting (reporting bias) | Unclear risk | Assessed all the pre-specified outcomes from the paper, but the trial protocol was not assessed |
Other bias | Unclear risk | No significant difference in baseline data reported on the criteria assessed, but difficult to say anything about all other types of bias |
BP: blood pressure
ERPC: evacuation of retained products of conception
GA: general anaesthetic
Hb: haemoglobin
ICM: incomplete miscarriage
ITT: intention to treat
IUFD: intrauterine fetal death
MVA: manual vacuum aspiration
RCT: randomised controlled trial
SD: standard deviation
VAS: visual analogue scale
vs: versus