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Two-Dose Methotrexate for Ectopic Pregnancy

Primary Purpose

Ectopic Pregnancy

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Methotrexate
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ectopic Pregnancy focused on measuring Ectopic pregnancy, Methotrexate

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Southern California Women's and Children's Hospital
  • University of Miami
  • University of Pennsylvania Reproductive Research Unit

Outcomes

Primary Outcome Measures

Prevalence of side effects

Secondary Outcome Measures

Efficacy of treatment of ectopic pregnancy (defined as no surgical intervention)

Full Information

First Posted
September 13, 2005
Last Updated
August 8, 2011
Sponsor
University of Pennsylvania
Collaborators
Bill and Melinda Gates Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00194272
Brief Title
Two-Dose Methotrexate for Ectopic Pregnancy
Official Title
Two-Dose Methotrexate for Ectopic Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
March 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Pennsylvania
Collaborators
Bill and Melinda Gates Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ectopic Pregnancy
Keywords
Ectopic pregnancy, Methotrexate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Methotrexate
Other Intervention Name(s)
Rheumatrex Dose Pack, Trexall
Intervention Description
Two dose methotrexate
Primary Outcome Measure Information:
Title
Prevalence of side effects
Time Frame
Till quantitative bhCG values fall to zero or below 5mIU/mL
Secondary Outcome Measure Information:
Title
Efficacy of treatment of ectopic pregnancy (defined as no surgical intervention)
Time Frame
Till quantitative bhCG values fall to zero or below 5mIU/mL

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kurt T Barnhart, MD, MSCE
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern California Women's and Children's Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33101
Country
United States
Facility Name
University of Pennsylvania Reproductive Research Unit
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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Two-Dose Methotrexate for Ectopic Pregnancy

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