Methods |
randomisation according to computer‐generated random number table
numbered sealed, opaque envelopes prepared by a person unrelated to the study
no blinding |
Participants |
20 pregnant women, ≤49 days, confirmed by ultrasound,
Magee‐Women's Hospital, Pennsylvania, USA
Exclusion criteria: previous use of vitamins/folates, hematocrit < 37%, 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 |
group 1: methotrexate 50mg/m2 followed by misoprostol 800mcg/vaginal after 7 days
group 2: methotrexate 60mg/m2 followed by misoprostol 800mcg/vaginal after 7 days |
Outcomes |
complete abortion, time to passing of conceptus, side effects, methotrexate levels,change in haemoglobin/aspartate transferase |
Notes |
no blinding
no major complications were reported |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |