Methods |
Women randomly allocated to 2 groups. Method of randomisation not reported |
Participants |
1100 women attending in a village clinic, Miyun county, Beijing, China. Women had regular menstrual periods and a single act of unprotected intercourse within 72 h of attending the clinic |
Interventions |
LNG 0.75 mg, 2‐dose, 12 h apart, orally vs LNG‐COC 4 tablets (total ethinyl oestradiol 0.12 mg and LNG 0.6 mg), 2‐dose, 12 h apart, orally |
Outcomes |
Observed number of pregnancies, side effects and changes in menstrual pattern |
Notes |
Observed pregnancy/total number of women: LNG 11/557 (user's failure 4); LNG‐COC: 14/553 (user's failure 6)
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Side effects:
LNG: nausea and vomiting 100/557; dizziness and fatigue 39/557
LNG‐COC: nausea and vomiting 227/553; dizziness and fatigue 45/553
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Changes in menstrual pattern:
Early: LNG 76/557; LNG‐COC 68/553
Delay: LNG 66/557; LNG‐COC 55/553
Spotting: LNG 61/557; LNG‐COC 73/553
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Mentioned randomisation but description not adequate |
Allocation concealment (selection bias) |
Unclear risk |
Method of allocation concealment not mentioned |
Blinding (performance bias and detection bias) All outcomes |
Unclear risk |
Not mentioned |
Incomplete outcome data (attrition bias) All outcomes |
Unclear risk |
No mention of post‐randomisation exclusion and loss to follow‐up |
Selective reporting (reporting bias) |
Low risk |
Reported planned outcomes |
Other bias |
Low risk |
None detected |