Comparison between single and double dose of Methotrexate in Ectopic Pregnancy
Phase 3
- Conditions
- Tubal pregnancy.Fallopian pregnancy
- Registration Number
- IRCT2013051110089N3
- Lead Sponsor
- Vice Chancellor for Research, Guilan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 146
Inclusion Criteria
1- Andexal mass with a size of 4 cm at maximum ; 2- ß–hCG titration level less than15000 mIU/mL; 3- Stable hemodynamic status -Blood Pressure > 90/60 mmHg and nonexistence of tachycardia ( Pulse Rate less than 100/min); 4-No fetal heart activity in gestational sac; 5- Consent for Methotrexate therapy and follow-up; 6- Normal laboratory tests(Platelet count more than 120000/µL , Serum Creatinin less than 1.2mg/dL or Aspartate aminotransferase less than double of normal level). Exclusion criteria: This study has not exclusion criteria .
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Treatment response in terms of basic ß-hCG titration level by ELIZA technique. Timepoint: After first week of treatment and 6 weeks follow-up period. Method of measurement: Determining ß-hCG titration level before treatment by ELIZA technique.;Therapeutic response to methotrexate. Timepoint: Day 4 and day 7, and its repetition weekly until 6 weeks. Method of measurement: Visit the patient and determining serum ß–hCG titration level by ELIZA technique.;Treatment response in terms of longest ectopic mass diameter on Transvaginal Sonography. Timepoint: After first week of treatment and 6 weeks follow-up period. Method of measurement: Determining the longest ectopic mass diameter in terms of Ultrasound report before treatment.
- Secondary Outcome Measures
Name Time Method Follow-up days. Timepoint: After treatment and since first week of follow-up. Method of measurement: Duration of Treatment and follow-up until ß–hCG titration level declined to less than 10 mIU/mL in terms of day by ELIZA technique.;Methotrexate side effects(Abdominal pain,Gastrointestinal symptoms,Alopecia ,Mucositis,Leukocyte count<4000,Platelet count<120000, Aspartate aminotransferase more than double level of normal). Timepoint: After treatment and on first week of follow up. Method of measurement: History, checking liver function tests and Complete Blood Count (CBC).