Methotrexate Treatment for Ectopic Pregnancy

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Brief Title

Methotrexate Treatment for Ectopic Pregnancy

Official Title

Comparison of Two-dose and Single-dose Methotrexate Protocol for Ectopic Pregnancy: a Randomized Controlled Trial

Brief Summary

      Ectopic pregnancy is an important cause of maternal morbidity and occasionally mortality.
      Deaths associated with ectopic pregnancy have declined, though approximately 75% of deaths in
      the first trimester and 9-13% of all pregnancy-related deaths are associated ectopic
      pregnancy. The main stays of management for ectopic pregnancy were surgery and medical
      treatment. Medical management with systemic methotrexate administration avoids the inherent
      morbidity of anesthesia and surgery is cost-effective, and also offers success rates
      comparable to surgical management, with no loss in future potential fertility.

      However, although medical management using methotrexate is used commonly, there is no solid
      consensus regarding dose protocol. Currently, there are three methotrexate protocols for the
      treatment of an ectopic pregnancy, "multi-dose", "single-dose", or "two-dose". Among them,
      the multi-dose protocol includes the administration of 4 methotrexate doses alternating with
      leucovorin (rescue regimen). As a result of the multiple dosing of methotrexate, side effects
      are more common. In contrast, the advantages of the single-dose protocol include elimination
      of a rescue regimen, lower incidence of adverse effects, and better compliance. However, the
      single-dose protocol was found to be associated with a considerably lower success rate as
      compared with the multi-dose protocol (88% versus 93%) in a recent meta-analysis. The
      two-dose protocol, which it balances efficacy and safety/convenience, was described as a
      cross between the multi-dose and single-dose protocols.

      However, there were a few studies comparing between single-dose and two-dose protocol. The
      purpose of this prospective randomized trial was to compared the success rates of single-dose
      and two-dose methotrexate protocol for the treatment of tubal ectopic pregnancy.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

treatment success


Condition

Ectopic Pregnancy

Intervention

Single-dose Methotrexate

Study Arms / Comparison Groups

 Single-dose methotrexate protocol
Description:  Participants in the "single-dose protocol" group received intramuscular methotrexate at single dose of 50 mg/m2 on day 0 (the initial day of treatment). The β-hCG levels were then measured on day 4 and 7. If there was at least 15% β-hCG drop between day 4 and 7, the treatment was deemed successful and the participants were then followed with weekly β-hCG measurements until the results was negative. If a 15% drop on day 4 and 7 did not occur, a second dose was administrated on day 7 and β-hCG levels were then measured on day 11 and 14. Participants were referred for surgical treatment if β-hCG levels fell <15% between day 11 and 14.

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

Procedure

Estimated Enrollment

92

Start Date

May 2013

Completion Date

April 2015

Primary Completion Date

April 2015

Eligibility Criteria

        Inclusion Criteria:

          -  tubal pregnancy

          -  tubal pregnancy except interstitial pregnancy

          -  a pretreatment β-hCG level <15000 mIU/mL

          -  a gestational sac with a largest diameter <4 cm

          -  hemodynamically stable status

          -  agreement to methotrexate treatment and follow up

        Exclusion Criteria:

          -  heterotrophic pregnancy

          -  a presence of embryonic cardiac motion

          -  clinically or sonographically suspected tubal rupture

          -  laboratory tests showing possible deleterious effects of methotrexate treatment on
             organ functions
      

Gender

Female

Ages

19 Years - 55 Years

Accepts Healthy Volunteers

No

Contacts

Taejong Song, M.D., , 

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

Administrative Informations


NCT ID

NCT01855568

Organization ID

KNC13-006


Responsible Party

Principal Investigator

Study Sponsor

CHA University


Study Sponsor

Taejong Song, M.D., Principal Investigator, CHA Gangnam Medical Center, Seoul, Republic of Korea


Verification Date

January 2016