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Two-Dose Methotrexate for Ectopic Pregnancy

This study has been completed.
Study NCT00194272.   Last updated on July 26, 2008.   Information provided by University of Pennsylvania

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Descriptive Information Fields
Brief Title  Two-Dose Methotrexate for Ectopic Pregnancy
Official Title  Two-Dose Methotrexate for Ectopic Pregnancy
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 more convenient for patients and has fewer side effects.

Study Phase Phase III
Study Type  Interventional
Study Design  Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary Outcome Measure  Prevalence of side effects [ Time Frame: Till quantitative bhCG values fall to zero or below 5mIU/mL ] [ Designated as safety issue: Yes ]
Secondary Outcome Measure  Efficacy of treatment of ectopic pregnancy (defined as no surgical intervention) [ Time Frame: Till quantitative bhCG values fall to zero or below 5mIU/mL ] [ Designated as safety issue: No ]
Condition  Ectopic Pregnancy
Intervention  Drug: Methotrexate
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  100
Start Date  March 2001
Completion Date June 2007
Eligibility 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
Gender Female
Ages
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00194272
Organization ID 701460
Secondary IDs †† RRU001
Study Sponsor  University of Pennsylvania
Collaborators †† Bill and Melinda Gates Foundation
Investigators 
Principal Investigator:     Kurt T Barnhart, MD, MSCE     University of Pennsylvania    
Information Provided By University of Pennsylvania
Verification Date July 2008
First Received Date  September 13, 2005
Last Updated Date July 26, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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