Medical Treatment in Ectopic Tubal Pregnancy

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Brief Title

Medical Treatment in Ectopic Tubal Pregnancy

Official Title

Treatment Success With Two Doses of Methotrexate vs Single Dose of Methotrexate in Ectopic Tubal Pregnancy

Brief Summary

      Ectopic pregnancy (EP) is estimated to be responsible for approximately 20% of all
      pregnancy-related mortality and 46% early pregnancy mortality.1 Hemodynamically stable women
      with EP are frequently managed with methotrexate (MTX) while multiple protocols like fixed
      multiple doses, single-dose as well as two-dose regimens have been in practice for treating
      EP, but no consensus exists regarding the optimum dosage regimen.
    

Detailed Description

      Literature reports multiple dosage regimens of MTX to be associated with increased rates of
      side effects. Single dose protocol has good compliance and fewer side effects but is linked
      with lower success rates in comparison to multiple dose protocols.

      A new treatment protocol involving "two-doses" of MTX for medical management of EP was
      introduced in 2007 but most of the research conducted so far has been retrospective in nature
      and limitations in study designs. No such study in recent years has been done in Pakistan to
      compare the success and safety of single-dose and two-dose MTX protocols so this study was
      planned to compare the success rates and safety of two-doses of MTX versus single dose of MTX
      in tubal EP.
    


Study Type

Interventional


Primary Outcome

success rate

Secondary Outcome

 frequency of Side-effects of treatment

Condition

Ectopic Pregnancy

Intervention

Methotrexate

Study Arms / Comparison Groups

 single-dose group
Description:  Women in single-dose group were administered a single-dose of intramuscular methotrexate as 50 mg/m2 on day-zero (the start of treatment).

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

100

Start Date

January 1, 2020

Completion Date

July 30, 2021

Primary Completion Date

July 30, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Diagnosis of tubal ectopic pregnancy.

          -  Pre-treatment beta-human chorionic gonadotrophin (β-hCG) level below 1500 mIU/ml.

          -  Gestational sac with largest diameter as 4cm.

          -  Willing to take methotrexate treatment.

          -  Willing to follow up.

        Exclusion Criteria:

          -  Heterotrophic pregnancy

          -  Persistent tubal pregnancy

          -  Embryonic cardiac motion

          -  Suspected tubal rupture

          -  Past history of harmful effects of methotrexate treatment on organ functions.
      

Gender

Female

Ages

20 Years - 35 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Rashida Parveen, FCPS, , 

Location Countries

Pakistan

Location Countries

Pakistan

Administrative Informations


NCT ID

NCT05208034

Organization ID

NishtarMU12


Responsible Party

Principal Investigator

Study Sponsor

Nishtar Medical University


Study Sponsor

Rashida Parveen, FCPS, Principal Investigator, Nishtar Medical University


Verification Date

January 2022