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IRCT201706199014N170 IRCT 2017-06-26 Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences Comparison of treatment effect of fixed and non-fixed interval prescription of Actinomycin-D on β-HCG level among patients with low-grade gestational trophoblastic neoplasia Comparison of treatment effect of fixed and non-fixed interval prescription of Actinomycin-D on β-HCG level among patients with low-grade gestational trophoblastic neoplasia: a double blind randomized clinical trial 2017-06-22 anticipated 76 Complete https://irct.ir/trial/9608 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomization: Random assignment of the patients to the intervention and control groups through drawing of lots. Blinding: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as double blind. 2 Trophoblastic neoplasia. Intervention 1: Intervention group 1: Actinomycin-D 1.25 mg per/square meter every 2 weeks for 3 months. Intervention 2: Intervention group 2: Actinomycin-D 1.25 mg per/square meter based on β-HCG level for 3 months.
public Dr Somayeh Heidari
Fatemieh Hospital, Pasdaran Ave.
Hamadan Iran (Islamic Republic of) +98 81 3828 3939 drsrezvan@gmail.com Fatemieh Hospital scientific Dr Mehrangiz Zamani
Fatemieh Hospital, Pasdaran Ave.
Hamadan Iran (Islamic Republic of) +98 81 3828 3939 m.zamani@umsha.ac.ir Fatemieh Hospital Iran (Islamic Republic of) Inclusion criteria: Age of 16 to 50 years; low-grade gestational trophoblastic neoplasia; no response to methotrexate. Exclusion criteria: Pregnancy or breastfeeding; history of herpes or chicken Pox infection; liver or kidney or bone marrow disorder. 16 years 50 years Female O01.9 Hydatidiform mole, unspecified Treatment - Drugs Treatment - Drugs Intervention group 1: Actinomycin-D 1.25 mg per/square meter every 2 weeks for 3 months. Intervention group 2: Actinomycin-D 1.25 mg per/square meter based on β-HCG level for 3 months. Measuring the serum level β-HCG. Timepoint: before intervention and every week for 1 month and then monthly for 3 months and then every 2 months for 6 months. Method of measurement: through laboratory test. Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences Approved 2017-06-10 Ethics Committee of Hamadan University of Medical Sciences Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan Iran (Islamic Republic of)