ectopic pregnancy. Ectopic pregnancy, unspecified
Conditions
Interventions
Intervention 1: One single intramuscular dose of methotrexate (50 milligrams per square meter of body surface area) along with two daily placebo tablets. Intervention 2: Intervention group: Methotrexa
Sponsors
Oroumia University of Medical Sciences
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Diagnosis of ectopic tubal pregnancy Serum ßhCG level increased by at least 60% compared to baseline within 48 hours Age between 18 and 45 years Serum ßhCG level less than 3500 IU/L Absence of fetal heartbeat detected by ultrasound Mean diameter of adnexal mass less than 3.5 cm Hemodynamically stable condition Absence of significant abdominal pain
Exclusion criteria
Exclusion criteria: history of hypersensitivity to methotrexate history of allergic reactions to letrozole or other aromatase inhibitors Lack of consent to medical treatment of ectopic pregnancy History of methadone use Presence of significant free pelvic fluid Diagnosis of liver disease or abnormal liver enzyme levels (ALT or AST) Diagnosis of renal disease or impaired kidney function (abnormal creatinine level) Heterotopic pregnancy (presence of ectopic pregnancy? concurrent with intrauterine pregnancy)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Medical treatment of ectopic pregnancy. Timepoint: Days one, four, and seven following treatment. Method of measurement: Serum Beta Human Chorionic Gonadotropin level measured by an immunoassay device (enzyme-linked immunosorbent assay kit ). | — |
Secondary
| Measure | Time frame |
|---|---|
| Need for surgical intervention. Timepoint: after intervention. Method of measurement: Clinical assessment of the need for laparoscopy or open surgery based on clinical criteria and imaging findings.;Hemodynamic instability. Timepoint: after intervention. Method of measurement: Measurement of blood pressure and heart rate; assessment of fluid and vasopressor requirements by the attending physician.;Frequency of nausea after treatment. Timepoint: after intervention. Method of measurement: Direct questioning of the patient and documentation in the adverse event follow-up form.;Frequency of abdominal pain after treatment. Timepoint: after intervention. Method of measurement: Assessment by patient questioning using the Visual Analogue Scale for pain.;Frequency of bodily pain after treatment. Timepoint: after intervention. Method of measurement: Documentation of patient report and clinical assessment in the follow-up form. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactRazieh Hosseinzadeh
Oroumia University of Medical Sciences
Outcome results
None listed