Comparison of success rates in the medical management of ectopic pregnancy with single-dose and multiple-dose administration of methotrexate: a prospective, randomized clinical trial.

OBJECTIVE: To assess whether success rate differs in single-dose versus multiple-dose administration of methotrexate (MTX) in medical management of unruptured ectopic pregnancies.

DESIGN: Prospective randomized clinical trial.

SETTING: Tertiary university hospital.

PATIENT(S): The study population included 108 patients presenting with unruptured ectopic pregnancies who fulfilled the criteria for medical management.

INTERVENTION(S): A single dose (study group) or multiple doses (control group) of MTX were administered IM.

MAIN OUTCOME MEASURE(S): Success rate of medical management in each group.

RESULT(S): Of the 54 patients on the single-dose protocol, treatment was considered successful in 48 patients (88.9%). Of the 54 patients on the multiple-dose protocol, 50 participants responded to the treatment (92.6%). The difference between success rates in the two groups was not statistically significant (P=.7; odds ratio 0.64; 95% confidence interval 0.17-2.4). In the single-dose and multiple-dose groups, 15 (27.8%) and 20 (37%) patients, respectively, had complications (P=.3).

CONCLUSION(S): The results of our study showed that single-dose treatment with MTX could be as successful as multiple doses. The incidence of complications did not differ between the two groups. It appears that single-dose treatment could be the first line of treatment in selected patients.