Methods | Women 'randomly allocated' to 3 groups. Random number generation by computer. Schedule prepared by someone not involved in recruitment and outcome assessment. No blinding or use of placebos reported. Side effects were recorded by women | |
Participants | 616 healthy women attending a community family planning clinic in Liverpool, UK Included women with regular menstrual periods (21‐35 days), aged 16‐45 years, with attended the clinic within 72 h of a single act of unprotected intercourse |
|
Interventions | Yuzpe (ethinyl oestradiol 100 μg + norgestrel 1 mg, repeated after 12 h) vs danazol 600 mg, twice, 12 h apart vs Mife 600 mg, single dose | |
Outcomes | Observed number of pregnancies, side effects and changes in menstrual pattern | |
Notes |
|
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "The allocation sequence was constructed by using a computer based pseudo‐random number generator with a uniform distribution." |
Allocation concealment (selection bias) | Unclear risk | "The schedule was prepared before the start of the study by JR, who did not participate in either the selection or assessment of women." No mention of method of concealment so unclear |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | No mention of blinding or placebo reported |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Attempts to explain loss to follow‐up but the numbers actually analysed don't add up to those remaining |
Selective reporting (reporting bias) | Low risk | Planned outcomes were reported |
Other bias | Low risk | None detected |