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. 2017 Aug 2;2017(8):CD001324. doi: 10.1002/14651858.CD001324.pub5
Methods Randomised, double‐blind, multicentre trial. Random number generation done centrally
Similar looking placebos were used
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
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
  1. Loss to follow‐up: split‐dose 15/560 and single dose 27/600

  2. Observed pregnancy/total number of women: split‐dose LNG 7/545, single‐dose LNG 4/573

  3. Of the failed cases 3 women in split‐dose group and 1 in single‐dose group continued with their pregnancies and delivered live, healthy babies, while the others were lost to follow‐up

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