Two-Dose Methotrexate for Ectopic Pregnancy

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania
• Collaborator: Bill and Melinda Gates Foundation
• Treatments: Methotrexate

Criteria

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