Two-Dose Methotrexate for Ectopic Pregnancy

Ectopic Pregnancy Clinical Trial

Official title:

Two-Dose Methotrexate for Ectopic Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00194272
• Other study ID #: 701460
• Secondary ID: RRU001
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: August 8, 2011
• Start date: March 2001
• Est. completion date: June 2007

Study information

• Verified date: August 2011
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ectopic Pregnancy
• Pregnancy, Ectopic

Intervention

Drug:
• Methotrexate
Two dose methotrexate

Locations

Country	Name	City	State
United States	University of Southern California Women's and Children's Hospital	Los Angeles	California
United States	University of Miami	Miami	Florida
United States	University of Pennsylvania Reproductive Research Unit	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Bill and Melinda Gates Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of side effects		Till quantitative bhCG values fall to zero or below 5mIU/mL	Yes
Secondary	Efficacy of treatment of ectopic pregnancy (defined as no surgical intervention)		Till quantitative bhCG values fall to zero or below 5mIU/mL	No