Two-Dose Methotrexate for Ectopic Pregnancy

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Brief Title

Two-Dose Methotrexate for Ectopic Pregnancy

Official Title

Two-Dose Methotrexate for Ectopic Pregnancy

Brief Summary

      This study examines the safety and acceptability of a novel "two dose" regimen of
      methotrexate to treat ectopic pregnancy.

Detailed Description

      The regimen is an attempt to create a middle ground between the 2 commonly used regimens -
      "single dose" and "multi dose". The "multi dose" regimen is more effective, but the "single
      dose" regimen is more convenient for patients and has fewer side effects.

Study Phase

Phase 3

Study Type


Primary Outcome

Prevalence of side effects

Secondary Outcome

 Efficacy of treatment of ectopic pregnancy (defined as no surgical intervention)


Ectopic Pregnancy




* 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


Estimated Enrollment


Start Date

March 2001

Completion Date

June 2007

Eligibility Criteria

        Inclusion Criteria:

          -  Confirmed diagnosis of ectopic pregnancy via

               -  D&E without products of conception identified on frozen pathology or

               -  VABRA without products of conception identified with pathologic evaluation or

               -  Ultrasound visualization of a gestational sac in the adnexa, with definitive
                  visualization of a yolk sac or fetal pole

          -  the subject is hemodynamically stable without signs of hemoperitoneum

          -  laparoscopy has not been performed

          -  the subject is able to return for frequent follow-up care

          -  normal renal and liver function have been documented within 2 days

          -  normal white blood count and platelet count have been documented as per laboratory

          -  normal chest x-ray was obtained if the subject has a history of pulmonary disease

          -  no history of allergy or sensitivity to methotrexate or any component of its

        Exclusion Criteria:

          -  breastfeeding

          -  laboratory evidence of immunodeficiency

          -  alcoholism or chronic liver disease

          -  the concomitant use of non-steroidal anti-inflammatory drugs

          -  blood dyscrasia such as leukopenia, thrombocytopenia, or severe anemia

          -  active pulmonary disease

          -  hepatic, renal, or hematological dysfunction

          -  adnexal mass > or = 3.5 cm

          -  presence of fetal cardiac motion

          -  active major psychiatric disorder such as major depression, bipolar disease, psychotic
             disorder, or drug addiction

          -  subjects unable or unwilling to comply with study procedures or illiterate




N/A - N/A

Accepts Healthy Volunteers



Kurt T Barnhart, MD, MSCE, , 

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID


Secondary IDs


Study Sponsor

University of Pennsylvania


 Bill and Melinda Gates Foundation

Study Sponsor

Kurt T Barnhart, MD, MSCE, Principal Investigator, University of Pennsylvania

Verification Date

August 2011