Methotrexate versus Expectant management in women with ectopic pregnancy.

The incidence of ectopic pregnancy is approximately 1-2 % of all pregnancies. An early diagnosis is possible by transvaginal sonography in combination with serum human chorionic gonadotrophin (hCG) measurements. Women with low but plateauing serum hCG concentrations have thus far been offered medical treatment with methotrexate. Systemtic methotrexate has been shown to be effective treatment for tubal pregnancy compared with surgery in several randomised trials. Methotrexate was cost effective in women with serum hCG < 2.000 IU/L but had a more negative impact on patients health related quality of life. Side effects include stomatitis, conjunctivitis, gastritis-enteritis, impaired liver function, bone marrow depression, and photosensitivity. Methotrexate has been shown to be safe with virtually no adverse effects reported on reproductive outcome. However, there is no evidence on the effects of treatment in this particular subgroup of women with low but plateauing serum hCG concentrations, which represents about 10% of women presenting with suspected ectopic pregnancy. Expectant management has been practiced based on the acknowledgement that the natural course of many early ectopic pregnancies is a self limiting process, ultimately resulting in tubal abortion or reabsorption. The objective is whether in women with suspected ectopic pregnancy with low but plateauing serum hCG concentrations additional treatment with systemic methotrexate in a single dose intramuscular regimen is superior over expectant management in terms of tubal rupture, future pregnancy, health related quality of life and costs.

To study whether in women with suspected ectopic pregnancy with low but plateauing serum hCG concentrations additional treatment with systemic methotrexate in a single dose intramuscular regimen is superior over expectant management in terms of tubal rupture, future pregnancy, health related quality of life and costs.

Systemic methotrexate in a single dose intramuscular regimen (1 mg/kg body weight) versus expectant management.