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IRCT201610085485N6 IRCT 2016-11-27 Women's Reproductive Health Research Center, Vice chancellor for research, Tabriz University of Medi Double and Single dose Methotrexate regimens in the treatment of ectopic pregnancy Comparison of Double and Single dose Methotrexate Protocols in the treatment of patients with tubal pregnancy 2016-10-22 anticipated 120 Complete https://irct.ir/trial/5886 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A medical treatment of ectopic pregnancy. Intervention 1: In the first group (single dose), we will administer 50 mg/m2 methotrexate IM on day 1, the serum day 4 and 7 β–hCG will be compared. If there is a drop of 15%, the treatment is considered effective, if not the next doses of methotrexate are administered on day 7,and again on day 11 if not effective with the same rule. If there is not a drop of 15% of β–hCG on day 14 in comparision to day 11, the drug therapy is failed and the patient will be operated. Intervention 2: In the second group (double dose), we will administer 50 mg/m2 methotrexate IM on day 1 and 4, the serum day 4 and 7 β–hCG will be compared. If there is a drop of 15%, the treatment is considered effective, if not the next doses of methotrexate are administered on day 7,and again on day 11 if not effective with the same rule. If there is not a drop of 15% of β–hCG on day 14 in comparision to day 11, the drug therapy is failed and the patient will be operated.
public Nazli Navali
Artesh street, Alzahra Hospita, infertility department
Tabriz Iran (Islamic Republic of) 5138665793 +98 41 3554 1221 navalin@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Nazli Navali
Infertility department, Alzahra Hospital, Artesh street
Tabriz Iran (Islamic Republic of) 5138665793 +98 41 3554 1221 navalin@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria are: stable hemodynamic state; adnexal mass diameter lower than 4 cm; the initial β–hCG lower than 10000 mIU/ml; no fetal heart activity by transvaginal sonography and, the request of fertility preservation. exclusion criteria are: creatinine above 1.5 mg/dl; platelets count lower than 100000/ml; white blood cells count lower than 2000/ml and; increased liver enzymes. 15 years 50 years Female O00.1 Tubal pregnancy Fallopian pregnancy Treatment - Drugs Treatment - Drugs In the first group (single dose), we will administer 50 mg/m2 methotrexate IM on day 1, the serum day 4 and 7 β–hCG will be compared. If there is a drop of 15%, the treatment is considered effective, if not the next doses of methotrexate are administered on day 7,and again on day 11 if not effective with the same rule. If there is not a drop of 15% of β–hCG on day 14 in comparision to day 11, the drug therapy is failed and the patient will be operated. In the second group (double dose), we will administer 50 mg/m2 methotrexate IM on day 1 and 4, the serum day 4 and 7 β–hCG will be compared. If there is a drop of 15%, the treatment is considered effective, if not the next doses of methotrexate are administered on day 7,and again on day 11 if not effective with the same rule. If there is not a drop of 15% of β–hCG on day 14 in comparision to day 11, the drug therapy is failed and the patient will be operated. Beta-hCG decrease. Timepoint: days 7, 11 and,14. Method of measurement: blood exam. Abdominal pain. Timepoint: daily and per patient report. Method of measurement: by visiting the patient and patient report. Drug side effects. Timepoint: days 4, 7 and, 11. Method of measurement: physical exam and blood tests. Women's Reproductive Health Research Center, Vice chancellor for research, Tabriz University of Medi Approved 2010-08-20 Ethics Committee of Tabriz University of Medical Sciences Research Deputy of Tabriz University of Medical Sciences, Golgasht street Tabriz Iran (Islamic Republic of)