Methods | RCT with randomisation of individual women in blocks of 10. | |
Participants | Inclusion criteria
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Interventions | Intervention: oral misoprostol.
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Outcomes | Successful miscarriage; adverse effects; 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) | Low risk | “….computer-generated random code, created in bocks of 10 at Genunity Health Projects’ Office in New York City.” |
Allocation concealment (selection bias) | Low risk | “The code was used by a Genunity employee who was not part of the research team as a basis for sealing cards in consecutively numbered envelopes… staff would open the next envelope in the numbered series…”. Although not opaque enveloped, we think the numbered series should be alright |
Blinding (performance bias and detection bias) All outcomes |
High risk | Not able to blind participants or clinicians. |
Incomplete outcome data (attrition bias) All outcomes |
Low risk | No loss to followup and no deviations from protocol allocation reported. ITT analysis |
Selective reporting (reporting bias) | Unclear risk | Report on pre-specified outcomes, though we have not assessed the trial protocol |
Other bias | Low risk | On most characteristics women did not differ significantly. But significantly more women in the misoprostol group had spontaneous miscarriage and were married. However, we considered that this probably will not have any impact on differences in outcome |