Back to resultsBHCG Level in Day 4,7, in Comparison to Day 10 as an Indicator for Treatment Success (BHCG)
Primary Purpose
Ectopic Pregnancy
Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Methotrexate
Sponsored by
About this trial
This is an interventional treatment trial for Ectopic Pregnancy focused on measuring MTX, Ectopic pregnancy, medical treatment
Eligibility Criteria
Inclusion Criteria:
- patients with ectopic pregnancy
- healthy
- hemodynamic stable
- first ectopic
Exclusion Criteria:
- hemodynamic non-stable
- abnormal liver or kidney function
- allergy reaction to MTX
Sites / Locations
- Dr. Zvi KleinRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MTX , treatment outcome
Arm Description
patient receiving MTX. in a dosage of 50 mg/m^2 , IM , in single dose
Outcomes
Primary Outcome Measures
To measure the change of levels of "BHCG" in patients receiving Methotrexate for treatment of ectopic pregnancy in days 4, 7, and 10 post treatment
To compeer levels of BHCG in days 4 and 7 to day 10 after injection of MTX. for Ectopic pregnancy treatment
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01860690
Brief Title
BHCG Level in Day 4,7, in Comparison to Day 10 as an Indicator for Treatment Success
Acronym
BHCG
Official Title
BHCG Level in Day 4,7, in Comparison to Day 10 as an Indicator for Treatment Success
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
November 2013 (Anticipated)
Study Completion Date
February 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators want to compeer BHCG levels after Methotrexate ( MTX). treatment for Ectopic pregnancy in days 4 and 7 after MTX. to day 10 . The hypothesis is that "BHCG" level in day 10 is the best indicator for treatment success , superior to day 4 and 7 . According to the investigators impression BHCG level rises in days 4 and 7 due to destruction of the trophoblast tissue , and only day 10 is an indicator for treatment success
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ectopic Pregnancy
Keywords
MTX, Ectopic pregnancy, medical treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MTX , treatment outcome
Arm Type
Experimental
Arm Description
patient receiving MTX. in a dosage of 50 mg/m^2 , IM , in single dose
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
50 mg / meter squer Intramuscular (IM) MTX.
Primary Outcome Measure Information:
Title
To measure the change of levels of "BHCG" in patients receiving Methotrexate for treatment of ectopic pregnancy in days 4, 7, and 10 post treatment
Description
To compeer levels of BHCG in days 4 and 7 to day 10 after injection of MTX. for Ectopic pregnancy treatment
Time Frame
the change of levels in days 4, 7, and 10 post MTX injection
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patients with ectopic pregnancy
healthy
hemodynamic stable
first ectopic
Exclusion Criteria:
hemodynamic non-stable
abnormal liver or kidney function
allergy reaction to MTX
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zvi Klein, Dr.
Phone
972-9-7472544
Email
kleinz@clalit.org.il
Facility Information:
Facility Name
Dr. Zvi Klein
City
Kefar-saba
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zvi Klein, MD
Phone
972-9-7472544
Email
kleinz@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Zvi Klein, M.D.
12. IPD Sharing Statement
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BHCG Level in Day 4,7, in Comparison to Day 10 as an Indicator for Treatment Success
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