Status:
COMPLETED
Two-Dose Methotrexate for Ectopic Pregnancy
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
Bill and Melinda Gates Foundation
Conditions:
Ectopic Pregnancy
Eligibility:
FEMALE
Phase:
PHASE3
Brief Summary
This study examines the safety and acceptability of a novel "two dose" regimen of methotrexate to treat ectopic pregnancy.
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00194272
Start Date
March 1 2001
End Date
June 1 2007
Last Update
August 9 2011
Active Locations (3)
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1
University of Southern California Women's and Children's Hospital
Los Angeles, California, United States, 90033
2
University of Miami
Miami, Florida, United States, 33101
3
University of Pennsylvania Reproductive Research Unit
Philadelphia, Pennsylvania, United States, 19104