Methods | Randomised, double‐blind trial. Random number generation done with a random computer‐generated list Same appearance, colour and shape capsules were used |
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Participants | 2418 healthy women recruited into the study from Eusebio Hernandez Hospital, Havana, Cuba Included women with regular menstrual cycles (24‐36 days), who had a single act of unprotected intercourse in the last 6 days of attending the hospital and no wish to be pregnant Excluded women who were not available for follow‐up, were pregnant or lactated, using hormonal contraceptives in the last 3 months and those who using any contraindication for mifepristone 1206 into 5 mg analysis, 1212 into 10 mg analysis |
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Interventions | Mife 5 mg versus 10 mg | |
Outcomes | Observed number of pregnancies, side effects and changes in menstrual pattern | |
Notes |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Assignation to the treatment groups was done by compiling a random computer generated list." |
Allocation concealment (selection bias) | Low risk | "People not participating in the study prepared sealed, opaque envelopes containing a card bearing the treatment group to which the patient would be assigned" |
Blinding (performance bias and detection bias) All outcomes | Low risk | "Double blinded." "Once the subject had been evaluated in line with the inclusion and exclusion criteria and had signed the informed consent, the envelope corresponding to the subjects numbered incorporation into the study was opened and she was included in the treatment group indicated on the card contained in the envelope: 'mifepristone A' or 'mifepristone B', where A corresponded to one dose and B to the other. This code was opened once data processing had finished; neither the doctors nor the subjects knew which group the subjects had been assigned to." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Exclusions reported‐ "Did not attend the visit n=2 and were excluded from data analysis" |
Selective reporting (reporting bias) | Low risk | Planned variables were reported |
Other bias | Low risk | None detected |