| Methods |
computer generated random table, opaque vials |
| Participants |
250 healthy women, </=56 days of amenorrhoea,
confirmed by ultrasound,
Exclusion criteria: evidence of threatened spontaneous abortion, uterine infection, anaemia, bleeding disorders, cardiovascular or cerebrovascular disease, uterine leiomyomata, allergy against the study medication. |
| Interventions |
group 1: mifepristone 200mg, misoprostol 800mcg/pv on day 3, repeated on day 4 if gestational sac present
group 2: Placebo, misoprostol 800mcg/pv on day 3, repeated on day 4 if gestational sac present |
| Outcomes |
successful abortion, side effects |
| Notes |
Placebos were vitamin C tablets (not identical); opaque vials
were used to blind the investigator
power calculation (5% significance level to detect a 5% difference in success rates between the 2 study groups)
no major complications were reported |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |
