Two-Dose Methotrexate for Ectopic Pregnancy

University of Pennsylvania

Status and phase

Completed

Phase 3

Conditions

Ectopic Pregnancy

Treatments

Drug: Methotrexate

Study type

Interventional

Funder types

Other

Identifiers

NCT00194272

701460

RRU001

Details and patient eligibility

About

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

Full description

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.

Enrollment

100 patients

Sex

Female

Volunteers

No Healthy Volunteers

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