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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Meir Medical Center
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01860690
First received: November 20, 2012
Last updated: May 22, 2013
Last verified: December 2012
  Purpose

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 Intervention Phase
Ectopic Pregnancy
Drug: Methotrexate
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: BHCG Level in Day 4,7, in Comparison to Day 10 as an Indicator for Treatment Success

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

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 [ Time Frame: the change of levels in days 4, 7, and 10 post MTX injection ] [ Designated as safety issue: No ]
    To compeer levels of BHCG in days 4 and 7 to day 10 after injection of MTX. for Ectopic pregnancy treatment


Estimated Enrollment: 100
Study Start Date: November 2011
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01860690     History of Changes
Other Study ID Numbers: BHCG1
Study First Received: November 20, 2012
Last Updated: May 22, 2013
Health Authority: Israel: Clalit Health Services

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
Pharmacologic Actions
Therapeutic Uses
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

ClinicalTrials.gov processed this record on August 28, 2014