Two-Dose Methotrexate for Ectopic Pregnancy

This study has been completed.

First Received on September 13, 2005. Last Updated on August 8, 2011 History of Changes

Sponsor:	University of Pennsylvania
Collaborator:	Bill and Melinda Gates Foundation
Information provided by:	University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT00194272

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 III

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:

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: Ectopic Pregnancy

Drug Information available for: Methotrexate

U.S. FDA Resources

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:

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

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
Cardiac Complexes, Premature
Pregnancy Complications
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 February 09, 2012