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IRCT20151020024625N16 IRCT 2023-04-04 Iran University of Medical Sciences Assessing the effectiveness of methotrexate and actinomycin D in the treatment of patients with C-section ectopic pregnancy Comparison of the effectiveness of methotrexate and actinomycin D in the treatment of patients with C-section ectopic pregnancy 2023-05-05 anticipated 32 Complete https://irct.ir/trial/69366 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomization, at first stage, 32 spheres from one to 32 are considered and following that will randomly divided into two equal parts, including "1" (Intervention1) and group 2 (Intervention2), and then using a lottery container, the ball of each group taken out and the intended sequence will be recorded, Blinding description: The blinding of the study is such that the care provider, outcome assessor and biostatistician do not know the content of the intervention. For administration, the drug is drawn by the researcher into the syringe and given to the clinical care provider for administration by mentioning the administration method. The outcome assessor records the outcome based on the patient's identity number according to the randomization table, and the data collected based on the number and mention of the first and second intervention is provided to the biostatistician for analysis. 3 C-Section Ectopic Pregnancy. Intervention 1: Intervention group: Methotrexate is given as a single dose of 50 mg by intramuscular injection. This dose is repeated after 14 days if there is no therapeutic result. Intervention 2: Intervention group: Actinomycin D is given as a single dose of 0.5 mg by intravenous infusion. This dose is repeated after 14 days if there is no therapeutic result. Yes - There is a plan to make this available What will be shared: The data collection will be presented anonymously. When: After publishing of the results, the data will be delivered upon request and after verification. To whom: The data will be available only for academic researchers. Conditions: In order to conduct similar studies. Where to obtain: Direct request from the scientific responsible. How to obtain: After request and authentication, the data will be provided. Comments:
public Dr. Setareh Nasiri Zeidi
Niyayesh Ave.
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6435 1000 setare_n99@yahoo.com Iran University of Medical Sciences scientific Dr. Setare Nasiri Zeidi
Niyayesh Ave.
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6435 1000 setare_n99@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Confirmed diagnosis of -section ectopic pregnancy no limit no limit Female Gestational age more than 13 weeks at the time of diagnosis Heavy vaginal bleeding Hemodynamic changes O00.9 Ectopic pregnancy, unspecified Treatment - Drugs Treatment - Drugs Intervention group: Methotrexate is given as a single dose of 50 mg by intramuscular injection. This dose is repeated after 14 days if there is no therapeutic result. Intervention group: Actinomycin D is given as a single dose of 0.5 mg by intravenous infusion. This dose is repeated after 14 days if there is no therapeutic result. Level of the blood chorionic gonadotropin hormone (BHCG). Timepoint: 4, 7, 14 and 21 days after intervention. Method of measurement: Enzyme-Linked Immunesorbent Assay (ELIZA). Iran University of Medical Sciences Approved 2022-08-06 Ethics Committee, Iran University of Medical Sciences Hemmat Expressway Tehran Tehran Iran (Islamic Republic of)