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Two-Dose Methotrexate for Ectopic Pregnancy
This study has been completed.
Study NCT00194272   Information provided by University of Pennsylvania
First Received: September 13, 2005   Last Updated: February 12, 2009   History of Changes

September 13, 2005
February 12, 2009
March 2001
 
Prevalence of side effects [ Time Frame: Till quantitative bhCG values fall to zero or below 5mIU/mL ] [ Designated as safety issue: Yes ]
Prevalence of side effects
Complete list of historical versions of study NCT00194272 on ClinicalTrials.gov Archive Site
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 ]
Efficacy of treatment of ectopic pregnancy (defined as no surgical intervention)
 
Two-Dose Methotrexate for Ectopic Pregnancy
Two-Dose Methotrexate for Ectopic Pregnancy

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

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.

Phase III
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Ectopic Pregnancy
Drug: Methotrexate
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
100
June 2007
 

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
Female
 
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00194272
Kurt T Barnhart, MD, MSCE, University of Pennsylvania
701460, RRU001
University of Pennsylvania
Bill and Melinda Gates Foundation
Principal Investigator: Kurt T Barnhart, MD, MSCE University of Pennsylvania
University of Pennsylvania
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP