Two-Dose Methotrexate for Ectopic Pregnancy

Study Overview
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Brief Summary
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This study examines the safety and acceptability of a novel two dose regimen of methotrexate to treat ectopic pregnancy.

Detailed Description
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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.

Official Title
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Two-Dose Methotrexate for Ectopic Pregnancy

Conditions
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Ectopic Pregnancy

Intervention / Treatment
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* Drug: Methotrexate


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Methotrexate|Two dose methotrexate|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of side effects |  | Till quantitative bhCG values fall to zero or below 5mIU/mL | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of treatment of ectopic pregnancy (defined as no surgical intervention) |  | Till quantitative bhCG values fall to zero or below 5mIU/mL | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ectopic pregnancy, Methotrexate