Comparison of the Therapeutic Response of Single dose and Double dose Methotrexate for the Treatment of Ectopic Pregnancy

Introduction &

Blastocyst implantation outside the uterine cavity is called ectopic pregnancy. Methotrexate administration is an appropriate medical treatment for the ectopic pregnancy. Methotrexate is administered in three protocols: single dose, double dose and multiple dose. The aim of this study was to compare the response to treatment with a single dose and double dose of methotrexate.

This double blind clinical trial study was done on 15-50 years old women with an ectopic pregnancy. Inclusion criteria included women with tubal EP that their adnexal mass was 4cm or less and their β-hCG level was below 15.000. Patients were randomly divided into two groups. The first group was treated with a single dose of methotrexate and the second group was treated with a double dose of methotrexate. Β-hCG level at determined intervals, the success rate, duration of treatment and the side effects of methotrexate was recorded and were compared for the two groups.

There was no statistically significant difference between the two groups in terms of mean age, BMI, Parity, history of spontaneous abortion, ectopic pregnancy, ovulation induction, IVF, initial complaint, the average gestational age and average diameter of the ectopic mass. But there was a significant difference in the average level of initial β-hCG between the two groups (P=0.005). Finally, it was found that no significant differences existed between the treatment success rates between the two groups (P=0.72). Also, the mean follow up on the successful treatment of the two groups showed no significant difference (P=0.22). Frequencies of adverse events in the successful treatment of the two groups showed no significant difference (abdominal pain P=0.31, gastro-intestinal symptoms P=0.8, oral mucositis P=0.26, hair loss P=0.35, and increases in liver enzymes P=0.23).

In the treatment of ectopic pregnancy, a double dose of methotrexate in patients with higher initial β-hCG had an equal safety and efficacy with that of single-dose methotrexate in patients with lower initial β-hCG. So in patient with higher β-hCG, double dose and in patients with lower β-hCG, single dose is recommended.