Ashok 2002.
Methods | Women randomised into 2 groups by opening sequentially‐numbered, sealed, opaque envelopes that were prepared using random number tables The study was not blinded and the clinician and patient were both aware of the treatment allocation |
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Participants | 1000 women attending family planning clinics in Aberdeen, UK. Women had regular menstrual periods and attended the clinic within 72 h of a single act of unprotected intercourse | |
Interventions | Mife 100 mg orally vs Yuzpe regimen (2 tablets each with ethinyl oestradiol 50 μg and LNG 0.25 mg) orally, 2 doses, 12 h apart | |
Outcomes | Observed number of pregnancies, side effects, change in menstrual pattern and patient acceptability | |
Notes |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Women were randomized into two groups by opening sequentially numbered, sealed opaque envelopes which were prepared using random number tables." |
Allocation concealment (selection bias) | Low risk | "Women were randomized into two groups by opening sequentially numbered, sealed opaque envelopes which were prepared using random number tables." |
Blinding (performance bias and detection bias) All outcomes | High risk | "The study was not blinded and the clinician and patient were both aware of the treatment allocated since patient acceptability was an outcome measure." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | ITT analysis was used "women allocated to a method of treatment were attributed to that method for the purpose of analysis, whether or not they had the particular method of treatment." |
Selective reporting (reporting bias) | Low risk | Planned outcomes were reported |
Other bias | Low risk | None detected |