Trial record 2 of 51 for:    ectopic pregnancy

Two-Dose Methotrexate for Ectopic Pregnancy

This study has been completed.
Sponsor:
Collaborator:
Bill and Melinda Gates Foundation
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00194272
First received: September 13, 2005
Last updated: August 8, 2011
Last verified: August 2011
  Purpose

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


Condition Intervention Phase
Ectopic Pregnancy
Drug: Methotrexate
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Two-Dose Methotrexate for Ectopic Pregnancy

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Prevalence of side effects [ Time Frame: Till quantitative bhCG values fall to zero or below 5mIU/mL ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 100
Study Start Date: March 2001
Study Completion Date: June 2007
Intervention Details:
    Drug: Methotrexate
    Two dose methotrexate
    Other Names:
    • Rheumatrex Dose Pack
    • Trexall
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00194272

Locations
United States, California
University of Southern California Women's and Children's Hospital
Los Angeles, California, United States, 90033
United States, Florida
University of Miami
Miami, Florida, United States, 33101
United States, Pennsylvania
University of Pennsylvania Reproductive Research Unit
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Bill and Melinda Gates Foundation
Investigators
Principal Investigator: Kurt T Barnhart, MD, MSCE University of Pennsylvania
  More Information

No publications provided

Responsible Party: Kurt T Barnhart, MD, MSCE, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00194272     History of Changes
Other Study ID Numbers: 701460, RRU001
Study First Received: September 13, 2005
Last Updated: August 8, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pennsylvania:
Ectopic pregnancy
Methotrexate

Additional relevant MeSH terms:
Pregnancy, Ectopic
Pregnancy Complications
Cardiac Complexes, Premature
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on August 26, 2014