Two-Dose Methotrexate for Ectopic Pregnancy - Full Text View

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

Genetics Home Reference related topics:

Brugada syndrome short QT syndrome

ChemIDplus related topics:

Methotrexate

U.S. FDA Resources

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

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

Responsible Party:	University of Pennsylvania ( Kurt T Barnhart, MD, MSCE )
Study ID Numbers:	701460, RRU001
First Received:	September 13, 2005
Last Updated:	July 26, 2008
ClinicalTrials.gov Identifier:	NCT00194272
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Pennsylvania:

Ectopic pregnancy

Methotrexate

Study placed in the following topic categories:

Folic Acid

Heart Diseases

Pregnancy Complications

Pregnancy, Ectopic

Ectopic pregnancy

Methotrexate

Cardiac Complexes, Premature

Arrhythmias, Cardiac

Additional relevant MeSH terms:

Antimetabolites

Antimetabolites, Antineoplastic

Immunologic Factors

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Physiological Effects of Drugs

Enzyme Inhibitors

Reproductive Control Agents

Folic Acid Antagonists

Abortifacient Agents, Nonsteroidal

Immunosuppressive Agents

Pharmacologic Actions

Pathologic Processes

Therapeutic Uses

Abortifacient Agents

Cardiovascular Diseases

Antirheumatic Agents

Dermatologic Agents

Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 05, 2008

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