Effectiveness Of Expectant Management In The Tubal Ectopic Pregnancy

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Brief Title

Effectiveness Of Expectant Management In The Tubal Ectopic Pregnancy

Official Title

Effectiveness Of Expectant Management In The Tubal Ectopic Pregnancy

Brief Summary

      Objectives: To evaluate if, when considering expectant management in tubal ectopic pregnancy
      if the complementary use of Methotrexate could provide better results. We evaluate the
      success of treatment and the time required for titers of β-hCG to become negative. Methods: A
      double-blind randomized study, held at the Department of Obstetrics UNIFESP. The patients
      will be divided into two groups: in one patients will be administered a single intramuscular
      dose of 50 mg/m2 of Methotrexate and in the other patients will be prescribed Placebo
      intramuscularly. The monitoring will be done by measurement of β-hCG in the 4th and 7th day.
      When the decline of beta-hCG titers was > 15% in this interval, the patient was followed with
      weekly dosing of β-hCG until the titers become negative. The criterion of success is when the
      β-hCG was negative. The treatment failure occurs when surgery was necessary.
    


Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

success of treatment

Secondary Outcome

 Blood tests before treatment with Methotrexate and Placebo

Condition

Ectopic Pregnancy

Intervention

Methotrexate

Study Arms / Comparison Groups

 Methotrexate
Description:  Administered a single intramuscular dose of 50 mg/m2 of Methotrexate.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

25

Start Date

September 2011

Completion Date

June 2013

Primary Completion Date

January 2013

Eligibility Criteria

        Inclusion Criteria:

          -  Hemodynamic stability

          -  Initial β-hCG <2000 mIU / mL

          -  Titers of β-hCG in decline in 48 hours before treatment

          -  Adnexal mass <5.0 cm

          -  Desire for future pregnancy

        Exclusion Criteria:

          -  Alive embryo

          -  Ectopic pregnancy other than in tubal location

          -  Pregnancy of unknown location
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Julio Elito Junior, , 

Location Countries

Brazil

Location Countries

Brazil

Administrative Informations


NCT ID

NCT01876004

Organization ID

CEP UNIFESP 0772/11


Responsible Party

Principal Investigator

Study Sponsor

Federal University of São Paulo


Study Sponsor

Julio Elito Junior, Study Director, Federal University of Sao Paulo


Verification Date

June 2013