Comparison of Two Different Protocols of Methotrexate Therapy in Medical Management of Ectopic Pregnancy.

BACKGROUND

Ectopic pregnancy (EP) is one of the most dangerous complications of pregnancy and without prompt diagnosis and treatment, it could become a major cause of maternal morbidity and mortality.

OBJECTIVES

In this randomized controlled study, we compared single and double dose of methotrexate (MTX) therapy in the treatment of ectopic pregnancy.

PATIENTS AND METHODS

This study was performed on 76 patients who were admitted to Obstetrics Ward with primary diagnosis of ectopic pregnancy based on their medical history, physical examination, beta subunit (β-HCG) level, and transvaginal ultrasonography. Using random block allocation, the patients were classified in two groups of single dose and double dose administration of MTX. In single dose group, 50 mg/m(2) of MTX was given at day 0 and in double dose group, the patients received two doses of MTX at day 0 and 4. The level of β-HCG was measured at day 0, 4, 7 in both groups. The successful treatment was defined as 15% reduction in β-HCG level between day 4 and 7. The two groups were compared with each other with regard to their need for operation, or extra dose of MTX; duration of hospitalization; and MTX complications.

RESULTS

Results showed that the rate of success in double dose method was more than single dose one (79% versus 69%) but the difference was not significant (P = 0.29). Although the need for operation and extra dose of MTX were lower in the double dose group (15.8% vs. 18.8% and 5.26% vs. 13.2%, respectively), these differences were not significant too. Duration of hospitalization was significantly lower in double dose compared to the single dose (11.55 d vs. 14.76 d, P < 0.001).

CONCLUSIONS

Single dose therapy of MTX has sufficient power and efficacy in the treatment of ectopic pregnancy, however in patients with higher serum level of β-HCG, the successful treatment increases by using double dose method. Using double dose also could decrease the necessity of operation, re-administration of MTX, and duration of hospitalization.