Methods |
randomisation according to computer‐generated random number table
numbered sealed, opaque envelopes
no blinding |
Participants |
86 pregnant women, ≤ 56 days of amenorrhoea, confirmed by ultrasound, San Francisco General Hospital
Exclusion criteria: previous use of vitamins/folates, hematocrit ≤ 0.30, 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, asthma, intolerance to the medication |
Interventions |
methotrexate 50mg/m2 intramuscular followed by:
group 1: misoprostol 800mcg/vaginal after 3 days
group 2: misoprostol 800mcg/vaginal after 7 days |
Outcomes |
complete abortion, duration of vaginal bleeding, side effects, change in beta‐HCG levels |
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 |