Two-Dose Methotrexate for Ectopic Pregnancy

Two-Dose Methotrexate for Ectopic Pregnancy

This study examines the safety and acceptability of a novel "two dose" regimen of methotrexate to treat ectopic pregnancy.

The regimen is an attempt to create a middle ground between the 2 commonly used regimens - "single dose" and "multi dose". The "multi dose" regimen is more effective, but the "single dose" regimen is more convenient for patients and has fewer side effects.

Inclusion Criteria:

• Confirmed diagnosis of ectopic pregnancy via

  • D&E without products of conception identified on frozen pathology or
  • VABRA without products of conception identified with pathologic evaluation or
  • Ultrasound visualization of a gestational sac in the adnexa, with definitive visualization of a yolk sac or fetal pole

• the subject is hemodynamically stable without signs of hemoperitoneum

• laparoscopy has not been performed

• the subject is able to return for frequent follow-up care

• normal renal and liver function have been documented within 2 days

• normal white blood count and platelet count have been documented as per laboratory standard

• normal chest x-ray was obtained if the subject has a history of pulmonary disease

• no history of allergy or sensitivity to methotrexate or any component of its formulation

Exclusion Criteria:

• breastfeeding
• laboratory evidence of immunodeficiency
• alcoholism or chronic liver disease
• the concomitant use of non-steroidal anti-inflammatory drugs
• blood dyscrasia such as leukopenia, thrombocytopenia, or severe anemia
• active pulmonary disease
• hepatic, renal, or hematological dysfunction
• adnexal mass > or = 3.5 cm
• presence of fetal cardiac motion
• active major psychiatric disorder such as major depression, bipolar disease, psychotic disorder, or drug addiction
• subjects unable or unwilling to comply with study procedures or illiterate