Two-Dose Methotrexate for Ectopic Pregnancy

Phase 3

Completed

• Conditions: Ectopic Pregnancy

• Registration Number: NCT00194272
• Lead Sponsor: University of Pennsylvania

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 Timeline

• Study Start: 2001-03
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-19
• Study Completion: 2007-06
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-08
• Last Update Posted: 2011-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Prevalence of side effects	Till quantitative bhCG values fall to zero or below 5mIU/mL

Secondary Outcome Measures

Name	Time	Method
Efficacy of treatment of ectopic pregnancy (defined as no surgical intervention)	Till quantitative bhCG values fall to zero or below 5mIU/mL

Trial Locations

Locations (3)

University of Miami; 🇺🇸 Miami, Florida, United States

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

University of Pennsylvania Reproductive Research Unit; 🇺🇸 Philadelphia, Pennsylvania, United States