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BHCG Level in Day 4,7, in Comparison to Day 10 as an Indicator for Treatment Success (BHCG)

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ClinicalTrials.gov Identifier: NCT01860690
Recruitment Status : Unknown
Verified December 2012 by Meir Medical Center.
Recruitment status was:  Recruiting
First Posted : May 23, 2013
Last Update Posted : May 23, 2013
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center

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

Condition or disease Intervention/treatment Phase
Ectopic Pregnancy Drug: Methotrexate Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: BHCG Level in Day 4,7, in Comparison to Day 10 as an Indicator for Treatment Success
Study Start Date : November 2011
Estimated Primary Completion Date : November 2013
Estimated Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: MTX , treatment outcome
patient receiving MTX. in a dosage of 50 mg/m^2 , IM , in single dose
Drug: Methotrexate
50 mg / meter squer Intramuscular (IM) MTX.



Primary Outcome Measures :
  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 [ Time Frame: the change of levels in days 4, 7, and 10 post MTX injection ]
    To compeer levels of BHCG in days 4 and 7 to day 10 after injection of MTX. for Ectopic pregnancy treatment



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01860690


Contacts
Contact: Zvi Klein, Dr. 972-9-7472544 kleinz@clalit.org.il

Locations
Israel
Dr. Zvi Klein Recruiting
Kefar-saba, Israel
Contact: Zvi Klein, MD    972-9-7472544    kleinz@clalit.org.il   
Principal Investigator: Zvi Klein, M.D.         
Sponsors and Collaborators
Meir Medical Center

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01860690     History of Changes
Other Study ID Numbers: BHCG1
First Posted: May 23, 2013    Key Record Dates
Last Update Posted: May 23, 2013
Last Verified: December 2012

Keywords provided by Meir Medical Center:
MTX
Ectopic pregnancy
medical treatment

Additional relevant MeSH terms:
Pregnancy, Ectopic
Pregnancy Complications
Cardiac Complexes, Premature
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors