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Completed

NCT Number: NCT00194272

Two-Dose Methotrexate for Ectopic Pregnancy

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

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

University of Southern California Women's and Children's Hospital, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 standard
  • 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 formulation

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

Treatment and study plan

methotrexate

Drug

Two dose methotrexate

Other names: Rheumatrex Dose Pack, Trexall

Primary outcomes

  1. Prevalence of side effects

    Time frame: Till quantitative bhCG values fall to zero or below 5mIU/mL

Secondary outcomes

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

    Time frame: Till quantitative bhCG values fall to zero or below 5mIU/mL

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Bill and Melinda Gates Foundation

Registry information

Important dates

Study start
2001
Study completion
2007
First posted
Sep 19, 2005
Registry last updated
Aug 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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