Adnexal Mass After Methotrexate Treatment for Ectopic Pregnancies

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Brief Title

Adnexal Mass After Methotrexate Treatment for Ectopic Pregnancies

Official Title

Adnexal Mass After Methotrexate Treatment for Ectopic Pregnancies

Brief Summary

      Ectopic pregnancies are a common morbidity in the gynaecological field. Previous work done by
      our team has shown the benefits of conservative treatment with only BHCG (Beta-Human
      Chorionic Gonadotropin) monitoring, proving that a vast number of patients will have a self
      resolution without the need for any further medical intervention. In addition, our working
      hypothesis is that this process in contrast to Methotrexate is a more physiologic one with
      less inflammatory and necrosis reaction.

      OBJECTIVE To measure and compare the size of the ectopic mass and monitor BHCG levels of
      women treated with Methotrexate and those that had a self resolution process of their ectopic
      pregnancy.

      Investigators aim to prove that the mass will have an enlargement trend after Methotrexate in
      contrast to being stable or decrease in size with conservative treatment.
    

Detailed Description

      Ectopic pregnancies are a common morbidity in the gynaecological field. Previous work done by
      our team has shown the benefits of conservative treatment with only BHCG (Beta-Human
      Chorionic Gonadotropin) monitoring, proving that a vast number of patients will have a self
      resolution without the need for any further medical intervention. In addition, our working
      hypothesis is that this process in contrast to Methotrexate is a more physiologic one with
      less inflammatory and necrosis reaction.

      OBJECTIVE To measure and compare the size of the ectopic mass and monitor BHCG levels of
      women treated with Methotrexate and those that had a self resolution process of their ectopic
      pregnancy.

      Investigators aim to prove that the mass will have an enlargement trend after Methotrexate in
      contrast to being stable or decrease in size with conservative treatment.

      PATIENTS & METHODS Patients that will be offered to join the study are those that will be
      with either treated by a Methotrexate injection or those that had signs of self resolution
      with our "Watchful waiting" protocol.
    


Study Type

Observational


Primary Outcome

ectopic mass size

Secondary Outcome

 BHCG values

Condition

Ectopic Pregnancies

Intervention

BHCG monitoring

Study Arms / Comparison Groups

 Methotrexate injection
Description:  Patients with Ectopic pregnancy treated with Methotrexate injection.

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

Other

Estimated Enrollment

500

Start Date

May 2017

Completion Date

October 2019

Primary Completion Date

October 2019

Eligibility Criteria

        Inclusion Criteria:

        All patients admitted and treated for a diagnosis of Ectopic pregnancy in The Department of
        Gynecology, Lis Maternity Hospital.

        Exclusion Criteria:

        none
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Ishai Levin, professor, 052-4266977, [email protected]



Administrative Informations


NCT ID

NCT03138694

Organization ID

614-16-TLV


Responsible Party

Sponsor

Study Sponsor

Tel-Aviv Sourasky Medical Center


Study Sponsor

Ishai Levin, professor, Principal Investigator, Tel Aviv Medical Center


Verification Date

May 2017