Two-Dose Methotrexate for Ectopic Pregnancy

Completed · Phase 3

Conditions studied: Ectopic Pregnancy

In brief

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

Key facts

Study ID

NCT00194272

Run by

University of Pennsylvania

People needed

100

Starts

2001-03-01

Expected to finish

2007-06-01

Last updated by the study team

2011-08-09

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Southern California Women's and Children's Hospital — Los Angeles, California, United States
• University of Miami — Miami, Florida, United States
• University of Pennsylvania Reproductive Research Unit — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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