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IRCT20101227005485N10 IRCT 2023-01-06 Tabriz University of Medical Sciences Comparison of three treatment methods in incisional pregnancy Comparison of three treatment methods in incisional pregnancy: methotrexate intrasac injection and potassium chloride intrasac injection and hysteroscopic resection 2023-01-20 anticipated 15 Complete https://irct.ir/trial/66508 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: In this study, the participants are unaware of the type of treatment they will receive. N/A cesarean scar. Intervention 1: Intervention group: injection of methotrexate in the amount of 1.5 square centimeters from an ampoule of 50 mg per 2 square centimeters from Daro Derman Pars Company into the sac or if the heartbeat exist, into the heart of the fetus. These patients will undergo curettage the next day, under transabdominal ultrasound control. Intervention 2: Intervention group: injection of KCL in the amount of 1.5 square centimeters of 15% solution made by the Pasteur Institute (equivalent to 3 milliequivalents), into the sac or if the heartbeat exist, into the heart of the fetus. These patients will undergo curettage the next day under transabdominal ultrasound control. Intervention 3: Intervention group: After a day of injecting 1 mg per square meter of intramuscular methotrexate, they will undergo hysteroscopic resection of cesarean scar pregnancy. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Nazli Navali
Artesh
Tabriz Iran (Islamic Republic of) 5138665793 +98 41 3554 1221 navalin@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Nazli Navali
Artesh
Tabriz Iran (Islamic Republic of) 5138665793 +98 41 3554 1221 navalin@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Definitive diagnosis of incisional pregnancy Stable hemodynamic status Absence of severe vaginal bleeding Consent to participate in the study Pregnancy less than 10 weeks no limit no limit Female History of drug sensitivity History of blood disorders Having liver disorders Having pulmonary disorders Treatment - Surgery Treatment - Surgery Treatment - Surgery Intervention group: injection of methotrexate in the amount of 1.5 square centimeters from an ampoule of 50 mg per 2 square centimeters from Daro Derman Pars Company into the sac or if the heartbeat exist, into the heart of the fetus. These patients will undergo curettage the next day, under transabdominal ultrasound control. Intervention group: injection of KCL in the amount of 1.5 square centimeters of 15% solution made by the Pasteur Institute (equivalent to 3 milliequivalents), into the sac or if the heartbeat exist, into the heart of the fetus. These patients will undergo curettage the next day under transabdominal ultrasound control. Intervention group: After a day of injecting 1 mg per square meter of intramuscular methotrexate, they will undergo hysteroscopic resection of cesarean scar pregnancy. The primary outcome of the study is the successful treatment of patients, which is the reduction of serum b-hCG levels until it become negative. Timepoint: Every week. Method of measurement: Radioimmunoassay. The primary outcome of the study is the successful treatment of patients, by confirming the empty uterus on the ultrasound exam. Timepoint: Every mounth. Method of measurement: Transvaginal sonography. Tabriz University of Medical Sciences Approved 2022-08-01 Ethics Committee of Tabriz University of Medical Sciences Research Deputy of Tabriz University of Medical Sciences, University of Tabriz, Golgasht street Tabriz East Azarbaijan Iran (Islamic Republic of)