Methods | Randomised, double‐blind multicentre trial. Random number generation done centrally, double‐blinded by use of identical placebos. Allocation concealment achieved by sealed, sequentially‐numbered, tinted bottles filled and labelled by manufacturer | |
Participants | 903 healthy women recruited in the study from 10 clinics in Shanghai, China Included women with regular menstrual periods (22‐42 days), who had a single act of unprotected intercourse within 120 h of attending the clinic and they were willing to avoid further acts of unprotected coitus during that cycle and willing to have an induced abortion if pregnancy was diagnosed following intake of the study drug during the study period Excluded women with current pregnancy or breastfeeding, on hormonal contraception in the current cycle and those with uncertain dates of last menstrual period |
|
Interventions | Mife 25 mg, 24 h later misoprostol 0.2 mg vs Mife 10 mg, 24 h later misoprostol 0.2 mg vs Mife (single dose) 10 mg + placebo | |
Outcomes | Observed number of pregnancies, side effects and changes in menstrual pattern | |
Notes |
|
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random number generation done centrally |
Allocation concealment (selection bias) | Low risk | Allocation concealment achieved by sealed, sequentially‐numbered, tinted bottles, filled and labelled by manufacturer |
Blinding (performance bias and detection bias) All outcomes | Low risk | Double‐blind |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Post‐randomisation exclusion and loss to follow‐up reported |
Selective reporting (reporting bias) | Low risk | Reported planned outcomes |
Other bias | Low risk | None detected |