Objectives: This study is aimed to compare the effect of single dose and multiple dose methotrexate in treatment of tubal pregnancy and fertility 1 year after treatment.
Design: Prospective randomized clinical trial. Setting and conduct : Tertiary regional and teaching hospital.
Participants including major eligibility criteria: Seventy patients, with gestational age less than 20 weeks; absence of bleeding in evidences of laparoscopic surgery and vaginal sonography, β -hCG less than 15000 mlU per mL undergoing treatment with methotrexate in Yazd Shahid Sadoughi Hospital during 2010-2011 , were included and patients with Creatinine levels more than 1.5 mg/kg, Platelet levels more than 100000/ml, W.B.C levels more than 2000/ml, Higher than 2 times increased liver enzyme levels were excluded. Patients were randomized into two groups of 35 each, using a table of random numbers.
Intervention: Group I patients received methotrexate (50 mg per m2 IM on day one ) and multiple dose ( 1 mg per kg per day) on days 1,3,5,7 and citrovoram factor (0.1mg per kg per day) were administered for 2,4,6,8 days.
Main outcome measures (variables): Adverse events,resolution of pregnancy without surgical treatment and Success rate of methotrexate treatment and fertility outcome in each group.
The medications are coded and delivered to the patients by and individual not aware of the research process.
A blind stuff assessed success rates of treatment by measuring drop in serum β - hCG level. Also, Researcher was unaware to each groups.