Comparison of single and multiple dose methotrexate therapy for unruptured tubal ectopic pregnancy: a prospective randomized study.

Objective: To compare the success rates of single and multiple dose methotrexate protocols for the treatment of unruptured tubal ectopic pregnancy.

Design: Prospective randomized controlled trial.

Setting: Maternity and teaching hospital in Turkey.

Population: One hundred twenty women treated with methotrexate therapy for unruptured tubal ectopic pregnancy.

Methods: Sixty-two women received a single dose and 58 received a multiple dose methotrexate regimen.

Main Outcome Measures: Success rate of methotrexate therapy (women successfully treated with one injection and women who completed four doses).

Results: In the single dose group, treatment was considered successful in 50 women (80.6%), whereas in the multiple dose group, 52 women (89.7%) responded to treatment (p = 0.21; OR 0.90, 95%CI 0.77-1.05). The average number of days required for human chorionic gonadotropin (hCG) levels to fall below 5 mU/mL was longer in the single dose (22.3 +/- 7.6) compared with the multiple dose group (18.3 +/- 10.7) (p = 0.03). In the single dose group fewer or 17 women (24.7%) experienced side-effects compared to 28 (48.3%) of those who had multiple doses (p = 0.02, OR 0.57, 95%CI 0.35-0.92).

Conclusion: A multiple dose methotrexate regimen for the treatment of unruptured tubal ectopic pregnancy is not more effective than a single dose one. In addition, multiple doses may cause more side-effects, but the time for hCG levels to fall below 5 mU/mL is shorter.