| Methods |
computer randomisation; sealed, opaque envelopes were numbered by a by a person unrelated to the study |
| Participants |
315 pregnant women, ≤ 63 days of amenorrhoea confirmed by ultrasound
Exclusion criteria: previous use of vitamins/folates, white blood cell count <3000/uL, platelet count <100 000/uL, haemoglobin <10.0 mg/dL, aspartate aminotransferase >2 times normal or active liver disease, serum creatinine >1.5 mg/dL or active renal disease, inflammatory bowel disease, intolerance to the medication |
| Interventions |
methotrexate 50mg oral on recruitment day and misoprostol 800mcg vaginal (self administered) on:
group 1: day 3
group 2: day 4
group 3: day 5
additional 800mcg misoprostol in 48 hours interval (up to 4 doses) |
| Outcomes |
complete, incomplete abortion (complete expulsion with additional doses of misoprostol), treatment failure, bleeding pattern, blood parameters, side effects |
| Notes |
power calculation (80% power, significance level of 0.05)
no major complications occurred |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |
