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IRCT20130311012782N40 IRCT 2020-02-25 Esfahan University of Medical Sciences omparison effect of single dose of Methotrexate and Actinomycin D in the prevention of gestational trophoblastic neoplasia in patients with high risk hydatidiform mole Comparison effect of single dose of Methotrexate and Actinomycin D in the prevention of gestational trophoblastic neoplasia in patients with high risk hydatidiform mole who refer to Shahid Beheshti and Azahra hospitals of Isfahan university of medical sciences in 2020 2020-04-02 anticipated 90 Complete https://irct.ir/trial/45014 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients were divided into 3 groups included intervention group1, intervention group 2 and control group by using Random Allocation Software. The total sample size is entered into the software and the number of groups is specified. The software specifies the patients in each group by random number. based on the time of referral, patients will be divided into two groups according to the schedule to reach the required sample size in each group, Blinding description: The study was a double-blind study and patients were unaware of the type of drug being administered. The drug is also prescribed by the researcher, but the data are collected by another specialist physician who is unaware of the type of intervention received. 3 gestational trophoblastic neoplasia. Intervention 1: Intervention group: Intravenous injection of a single dose of actinomycin D and then washing the vein with 10 ml distilled water one hour before suction curettage. Intervention 2: Intervention group: Intramuscular injection of 50 mg methotrexate one hour before curettage suction. Intervention 3: Control group: Intramuscular injection of one ampule B complex one hour before suction curettage. No - There is not a plan to make this available Justification or reason for not sharing IPD is The project is owned by the state agency and cannot be published
public Samaneh Maghzi
Department of gynecology, Sofehh street, Alzahra hospital
Isfahan Iran (Islamic Republic of) 8434193474 +98 31 3669 5555 samaneh.maghzi@gmail.com Esfahan University of Medical Sciences scientific Fahimeh Sabet
Department of gynecology, Alzahra hospital, Soffeh street
Isfahan Iran (Islamic Republic of) 8434193474 +98 31 3669 5555 f_sabet@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Full molar pregnancy mother age above 40 years old Patient's consent to participate in the study Patient Preparation for Surgery and Termination of Pregnancy with Suction for Molar Discharge Having risk factors for pregnancy progression to trophoblastic neoplasia 40 years no limit Female serum level of B-hCG >=100000 iu/ml theca lutein cyst size >=6 cm O01.9 gestational trophoblastic neoplasm Prevention Prevention Prevention Intervention group: Intravenous injection of a single dose of actinomycin D and then washing the vein with 10 ml distilled water one hour before suction curettage Intervention group: Intramuscular injection of 50 mg methotrexate one hour before curettage suction Control group: Intramuscular injection of one ampule B complex one hour before suction curettage Incidence of gestational trophoblastic neoplasia in Molar pregnancy. Timepoint: Every week for three weeks and the 6 months later. Method of measurement: measurement of beta HCH. Esfahan University of Medical Sciences Approved 2019-12-20 Ethics committee of Isfahan University of Medical Sciences Research faculty, Isfahan University of Medical Sciences, Hezar Jerib street, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)