Comparison of the effect of methotrexate dose in the treatment of patients with ectopic pregnancy
Phase 2
- Conditions
- Ectopic pregnancy.Ectopic pregnancy, unspecifiedO00.9
- Registration Number
- IRCT20120716010297N7
- Lead Sponsor
- Esfahan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 108
Inclusion Criteria
Satisfaction with participating in the study
Confirmation of ectopic pregnancy by ultrasound and ßHCG
Stable hemodynamic status
the gestational sac with the largest diameter of, 4 cm;
Existence of low free fluid in the abdominal and pelvic cavity based on ultrasound.
Exclusion Criteria
The presence of active hepatitis
The presence of kidney disease
Use of immunosuppressive drugs
History of severe allergy to methotrexate
Leukopenia in patient CBC tests
Hematopoiesis disorder
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Serum ßHCG level. Timepoint: On days 1, 3, 5 and 7 after injection of methotrexate. Method of measurement: blood test.;Outcome of treatment. Timepoint: 6 weeks after starting treatment. Method of measurement: The outcome of treatment is assessed as follows: The success of single-dose treatment means a 5% reduction in serum hCG levels after one week of treatment and a serum level of less than 5 mIU / mL after 6 weeks of treatment. In the multi-dose regimen, a 15% decrease in hCG serum levels after 48 hours of treatment or after 4 therapeutic doses, or hCG serum levels less than 5 mIU / mL after 6 weeks of treatment will be regarded as success of treatment.
- Secondary Outcome Measures
Name Time Method Methotrexate complications such as Hair loss, gastroenteritis, Neutropenia, Fever, and Increase in liver enzyme. Timepoint: during the treatment up to six weeks after. Method of measurement: Clinical observation and doctor's diagnosis.