Objective: To compare efficacy between double-dose methotrexate and single-dose methotrexate for treat
ment of tubal ectopic pregnancy (EP). Methods: Between March 2008 and February 2011,157 patients who
had tubal EP diagnosed by a non-laparoscopic approach and were hemodynamically stable were enrolled
in a prospective study in Qassim, Saudi Arabia. The participants were randomized to receive either double
m2
/m2
dose (50 mg/
intramuscularly on days 0 and 4; group 1) or single-dose (50 mg
intramuscularly on
day 0; group 2) methotrexate. Serum human chorionic gonadotropin (.-hCG) levels were followed until neg
ative. Results: The overall success rate was comparable between groups 1 and 2 (88.6% versus 82.0%, P=0.1).
The duration of follow up until negative .-hCG was shorter in group 1 (P=0.001). Receiver operative char
acteristics showed that higher cut-off levels of .-hCG and gestational mass diameter were associated with
successful outcome in group 1. Among participants with initial .-hCG of 3600–5500 mIU/mL, the success
rate was higher in group 1 (P=0.03). There was no significant difference between groups in adverse effects.
Conclusion: For treatment of EP, double-dose methotrexate had efficacy and safety comparable to that of sin
gle- dose methotrexate; it had better success among patients with moderately high .-hCG and led to a
shorter follow up.