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

May 22, 2013 updated by: Meir Medical Center
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Kefar-saba, Israel
        • Recruiting
        • Dr. Zvi Klein
        • Contact:
        • Principal Investigator:
          • Zvi Klein, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
the change of levels in days 4, 7, and 10 post MTX injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meir Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (ANTICIPATED)

November 1, 2013

Study Completion (ANTICIPATED)

February 1, 2014

Study Registration Dates

First Submitted

November 20, 2012

First Submitted That Met QC Criteria

May 22, 2013

First Posted (ESTIMATE)

May 23, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

May 23, 2013

Last Update Submitted That Met QC Criteria

May 22, 2013

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BHCG1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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