BHCG Level in Day 4,7, in Comparison to Day 10 as an Indicator for Treatment Success
BHCG
1 other identifier
interventional
100
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Nov 2011
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 20, 2012
CompletedFirst Posted
Study publicly available on registry
May 23, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedMay 23, 2013
December 1, 2012
2 years
November 20, 2012
May 22, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
the change of levels in days 4, 7, and 10 post MTX injection
Study Arms (1)
MTX , treatment outcome
EXPERIMENTALpatient receiving MTX. in a dosage of 50 mg/m\^2 , IM , in single dose
Interventions
Eligibility Criteria
You may qualify if:
- patients with ectopic pregnancy
- healthy
- hemodynamic stable
- first ectopic
You may not qualify if:
- hemodynamic non-stable
- abnormal liver or kidney function
- allergy reaction to MTX
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dr. Zvi Klein
Kfar Saba, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2012
First Posted
May 23, 2013
Study Start
November 1, 2011
Primary Completion
November 1, 2013
Study Completion
February 1, 2014
Last Updated
May 23, 2013
Record last verified: 2012-12