Methods | Randomised, double‐blind, multicentre trial. Random number generation done centrally Similar looking placebos were used |
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Participants | 1160 healthy women recruited into the study from family planning clinics, University College Hospital, Ibadan, and Planned Parenthood Federation of Nigeria, Ikolaba, Ibadan Included women with regular menstrual periods (21‐35 days), who had attended the clinic within 72 h of a single act of unprotected intercourse Excluded women who were not available for follow‐up, were pregnant, on hormonal contraception in the current cycle and those who had contraindications to the use of hormonal contraceptive pills. 1118 into efficacy analysis, 1062 into safety analysis |
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Interventions | LNG 0.75 mg, 2 doses, 12 h apart orally (split dose) vs LNG 1.5 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) | Low risk | "participants were randomised into two groups (A and B) using a computer generated random table." |
Allocation concealment (selection bias) | Unclear risk | No explanation of allocation concealment |
Blinding (performance bias and detection bias) All outcomes | Low risk | "These were administered by a family planning nurse who was blind to the contents in the boxes." "The medications were packed in similar boxes, each tagged with the users name, and containing two tablets. Group A took the box containing one 0.75 mg levonorgestrel tablet and one similarly looking, inactive placebo tablet" Double‐blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Explained loss to follow‐up |
Selective reporting (reporting bias) | Low risk | Reported planned outcomes |
Other bias | Low risk | None detected |