Methods | Women were included in the double‐blind, controlled trial and randomly assigned into 2 groups | |
Participants | 529 participants aged 15‐49 having regular menses (having regular menstrual cycles of 24‐42 days) and one act of unprotected intercourse within 72h were included in the trial in 2006‐2007 in Iran; breast‐feeding women were also included provided that their baby was older than 6 months. Exclusion criteria were breast‐feeding women with their baby younger than 6 months, hormonal contraindication in their current cycle, use of hormonal contraceptives, uncertainty about the time of last menstrual period, and suspected pregnancy |
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Interventions | LNG 0.75 mg, 2‐dose regimen vs Yuzpe regimen | |
Outcomes | Observed number of pregnancies, specific side effects and changes in menstrual pattern | |
Notes | 1. Observed pregnancy/total number of women: Yuzpe 3/266; LNG 4/263 2. Balanced block randomisation |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Participants were then classified according to balanced block randomisation." |
Allocation concealment (selection bias) | Unclear risk | Method of allocation concealment not stated |
Blinding (performance bias and detection bias) All outcomes | Low risk | "Neither the obstetrics, nor the participants were aware of the type of tablets in each set (double blind). Only the person responsible for randomization was aware of the contents of the sets according to the serial numbers stuck on the sets." |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No mention of any loss to follow‐up or how many were analysed |
Selective reporting (reporting bias) | Low risk | Planned outcomes in the protocol were reported |
Other bias | Low risk | None detected |