Ectopic Pregnancy
Conditions
Keywords
Ectopic pregnancy, Methotrexate
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.
Interventions
DRUGMethotrexate
Two dose methotrexate
Sponsors
Bill and Melinda Gates Foundation
University of Pennsylvania
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prevalence of side effects | Till quantitative bhCG values fall to zero or below 5mIU/mL |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy of treatment of ectopic pregnancy (defined as no surgical intervention) | Till quantitative bhCG values fall to zero or below 5mIU/mL |
Countries
United States
Outcome results
None listed