Methods | Randomly allocated women to 2 treatment groups within predefined age groups (16‐25 years, 26‐34 years, 35‐45 years). Cards with the treatment names on were put in sealed envelopes and allocation was made by shuffling the cards. There was no blinding, placebos were not used. Side effects were assessed by women |
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Participants | 800 women attending a family planning clinic and an accident and emergency department in Edinburgh, UK Included women with regular menstrual periods, aged 16‐45 years who had attended the clinic within 72 h of a single act of unprotected intercourse Excluded women on oral contraceptives, regular prescription drugs, with medical contraindications, who were difficult to follow up and who would continue with the pregnancy in case of a failure |
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Interventions | Yuzpe (ethinyl oestradiol 100 μg + norgestrel 1 mg, repeated after 12 h) vs Mife 600 mg, single dose | |
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) | Unclear risk | Explanation for method of randomisation not provided |
Allocation concealment (selection bias) | Unclear risk | Method of allocation concealment not explained |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | No mention of blinding |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Exclusions reported "26 women were lost to follow up" "A total of 693 women returned completed diary charts" (and were hence analysed) |
Selective reporting (reporting bias) | Low risk | Planned variables were reported |
Other bias | Low risk | None detected |