Two-Dose Methotrexate for Ectopic Pregnancy

Sponsor

University of Pennsylvania (Other)

Overall Status

Completed

CT.gov ID

NCT00194272

Collaborator

Bill and Melinda Gates Foundation (Other)

100

Enrollment

Locations

Duration (Months)

33.3

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Ectopic Pregnancy	Drug: Methotrexate	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Two-Dose Methotrexate for Ectopic Pregnancy

Study Start Date :

Mar 1, 2001

Actual Study Completion Date :

Jun 1, 2007

Outcome Measures

Primary Outcome Measures

Prevalence of side effects [Till quantitative bhCG values fall to zero or below 5mIU/mL]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Southern California Women's and Children's Hospital	Los Angeles	California	United States	90033
2	University of Miami	Miami	Florida	United States	33101
3	University of Pennsylvania Reproductive Research Unit	Philadelphia	Pennsylvania	United States	19104