Objective: To evaluate the safety and acceptability of a novel dosing regimen of methotrexate to treat ectopic pregnancy.
Design: Prospective study.
Setting: Three academic medical centers.
Patient(s): One hundred one patients with ectopic pregnancy who elected to have medical therapy.
Intervention(s): Intramuscular methotrexate 50 mg/m(2) was administered on days 0 and 4; additional doses of methotrexate were given on day 7 and/or day 11 if hCG levels did not decrease by 15% during the follow-up period.
Main outcome measure(s): Adverse events, acceptability, and resolution of pregnancy without surgical treatment.
Result(s): With this protocol, 87% of patients were treated successfully. Of those protocols that were considered failures, only 3% of patients experienced rupture of ectopic pregnancy. Treatment was well-tolerated; most side effects were reported as mild and transient. Ninety-one percent of the 61.5% of patients who responded to the satisfaction questionnaire reported satisfaction with this regimen.
Conclusion(s): This "2-dose" protocol minimizes the number of injections and surveillance visits, compared with the "multiple dose" regimen, and methotrexate is administered more frequently than with the "single dose" regimen. The protocol may optimize the balance between convenience and efficacy. In a limited number of women, no safety concerns were noted with up to 4 doses of methotrexate in a 2-week period without leucovorin rescue.