Two-Dose Methotrexate for Ectopic Pregnancy - Tabular View

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Two-Dose Methotrexate for Ectopic Pregnancy

This study has been completed.

Study NCT00194272. Last updated on July 26, 2008. Information provided by University of Pennsylvania

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Two-Dose Methotrexate for Ectopic Pregnancy

Official Title ^†

Two-Dose Methotrexate for Ectopic Pregnancy

Brief Summary

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

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.

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

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

Secondary Outcome Measure ^†

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 ]

Condition ^†

Ectopic Pregnancy

Intervention ^†

Drug: Methotrexate

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

100

Start Date ^†

March 2001

Completion Date

June 2007

Eligibility 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

Gender

Female

Ages

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00194272

Organization ID

701460

Secondary IDs ^††

RRU001

Study Sponsor ^†

University of Pennsylvania

Collaborators ^††

Bill and Melinda Gates Foundation

Investigators ^†

Principal Investigator:

Kurt T Barnhart, MD, MSCE

University of Pennsylvania

Information Provided By

University of Pennsylvania

Verification Date

July 2008

First Received Date ^†

September 13, 2005

Last Updated Date

July 26, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.