Methods | Enrolled women randomly assigned to receive UPA 30 mg or LNG 1.5 mg orally. Randomisation schedule stratified by site and time from unprotected sexual intercourse to treatment (within 72 h and 72–120 h) with a block size of 4 Single‐blind (women masked to treatment assignment, whereas those giving the interventions and study investigators were not, since the study drugs differed in appearance (different tablet size and blister pack)) |
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Participants | Women with regular menstrual cycles who presented to a participating family planning clinic requesting emergency contraception within 5 days of unprotected sexual intercourse were eligible for enrolment Randomised, multicentre, non‐inferiority trial 2221 women randomly assigned to UPA (CDB‐2914) (n = 1104) or LNG (n = 1117) |
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Interventions | UPA 30 mg vs LNG 1.5 mg, single dose, orally | |
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 | "The randomization schedule was stratified by site and time from unprotected sexual intercourse to treatment with a block size of four." Computer generated |
Allocation concealment (selection bias) | Low risk | "allocation concealment by identical opaque boxes labelled with a unique treatment number" "Only after registration and request for randomization did the system allocate a treatment number to the participant from the lot available on site, according to the randomization schedule." |
Blinding (performance bias and detection bias) All outcomes | Low risk | "The study was single blind‐ i.e. participants were masked to treatment assignment, whereas those giving the interventions and study investigators were not, since the study drugs differed in appearance. Study drug blister packs were packaged individually in identical opaque boxes labelled with a unique treatment number". "The investigator or nurse took the appropriate treatment pack from storage, removed the tablet from the blister pack out of sight of the participant, and gave it to the participant under direct supervision". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | ITT analysis used and participant withdrawals explained |
Selective reporting (reporting bias) | Low risk | Planned outcomes from protocol reported |
Other bias | Low risk | None detected |