Two-Dose Methotrexate for Ectopic Pregnancy

This study has been completed.

First Received: September 13, 2005 Last Updated: February 12, 2009 History of Changes

Sponsors and Collaborators:	University of Pennsylvania 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:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Two-Dose Methotrexate for Ectopic Pregnancy

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

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

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:	University of Pennsylvania ( Kurt T Barnhart, MD, MSCE )
Study ID Numbers:	701460, RRU001
Study First Received:	September 13, 2005
Last Updated:	February 12, 2009
ClinicalTrials.gov Identifier:	NCT00194272 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Pennsylvania:

Ectopic pregnancy
Methotrexate

Study placed in the following topic categories:

Antimetabolites
Pregnancy Complications
Heart Diseases
Pregnancy, Ectopic
Immunologic Factors
Folate
Folinic Acid
Folic Acid Antagonists

Cardiac Complexes, Premature
Immunosuppressive Agents
Vitamin B9
Folic Acid
Ectopic Pregnancy
Methotrexate
Antirheumatic Agents
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Antimetabolites
Pregnancy Complications
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Reproductive Control Agents
Pathologic Processes
Therapeutic Uses
Abortifacient Agents
Methotrexate
Cardiovascular Diseases

Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Heart Diseases
Pregnancy, Ectopic
Enzyme Inhibitors
Abortifacient Agents, Nonsteroidal
Folic Acid Antagonists
Cardiac Complexes, Premature
Immunosuppressive Agents
Pharmacologic Actions
Antirheumatic Agents
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on July 02, 2009