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IRCT20211109053019N1 IRCT 2022-11-26 Karaj University of Medical Sciences Prophylactic effect of Tranexamic acid in decreasing hemorrhage in elective cesarean section Evaluation the effect of Tranexamic acid infusion with oxytocin versus oxytocin alone before elective cesarean section in prevention preoperative and post operative hemorrhage in Karaj Kamali Hospital: A randomized clinical trial study 2022-11-22 anticipated 200 Complete https://irct.ir/trial/59906 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Volunteers participating in the study divided into two groups: intervention and control, using a table of computer random numbers in envelopes in the package, Blinding description: After randomizing people, the envelopes in the package are opened by the anesthesia technician and the anesthesiologist is in the process of assigning the grouping but patient and surgeon and person completing the questionnaire and people who did statistical analysis, They do not know the grouping of patients. 3 Post partum hemorrhage after elective cesarean section. Intervention 1: Intervention group: The person 20 minutes before the operation and incision of the skin will receive 1 g of tranexamic acid diluted in 20 cc of 5% dextrose intravenously. Also after the umbilical cord clamp, 30 units of oxytocin in 500 cc of Ringer serum will be received intravenously. Intervention 2: Control group: The person 20 minutes before the operation and incision of the skin will receive placebo in 20 cc of 5% dextrose intravenously. Also after the umbilical cord clamp, 30 units of oxytocin in 500 cc of Ringer serum will be received intravenously. Yes - There is a plan to make this available What will be shared: All data can be shared after de-identifying individuals When: The access period starts 6 months after the results are published To whom: Research centers and faculty members Conditions: According to the request of the researcher and the request of the academic staff Where to obtain: Send an email to the responsible scientific person How to obtain: Documents will be sent to the mentioned people within two months from the time of the request and sending the email Comments:
public Dr Ramesh Baradaran Bagheri
Beheshti Street
Karaj Iran (Islamic Republic of) 3134877179 +98 26 3222 2021 elham.ghafarinia@gmail.com Karaj University of Medical Sciences scientific Dr Ramesh Baradaran Bagheri
Beheshti
Karaj Iran (Islamic Republic of) 3134877179 +98 26 3222 2021 elham.ghafarinia@gmail.com Karaj University of Medical Sciences Iran (Islamic Republic of) Singleton pregnancy Age over 18 years old Gestational age over 34 weeks Hemoglobin level before operation over 10 mg/dl Platelets over 100000 Be an elective cesarean section candidate 18 years no limit Female Emergency cesarean section Age less than 18 years old History of deep vein thrombosis or pulmonary emboli History of arterial thrombosis( pectoralis angina, myocardial infarction or stroke) History of convulsion or epilepsy Any known active cardiovascular or liver or kidney disorder Autoimmune disease Sickle cell disease Severe bleeding disease Placenta previa Placenta accreta spectrum Preeclampsia or eclampsia Gestational hypertension or chronic hypertension Hemolysis or low platelet Intrauterine fetal death Allergy to tranexamic acid Multifetal pregnancy Sever polyhydramnios History of recurrent abortion Uterine fibroma History of rheumatologic disease Varicose veins Pre partum hemorrhage Sever intra abdominal adhesions during surgery Damage to bladder or intestines or other organs during surgery Unsuccessful operative vaginal delivery O72 Postpartum hemorrhage Prevention Placebo Intervention group: The person 20 minutes before the operation and incision of the skin will receive 1 g of tranexamic acid diluted in 20 cc of 5% dextrose intravenously. Also after the umbilical cord clamp, 30 units of oxytocin in 500 cc of Ringer serum will be received intravenously. Control group: The person 20 minutes before the operation and incision of the skin will receive placebo in 20 cc of 5% dextrose intravenously. Also after the umbilical cord clamp, 30 units of oxytocin in 500 cc of Ringer serum will be received intravenously. Measurement of hemoglobin after cesarean section. Timepoint: 24 hours after surgery. Method of measurement: Using laboratory vein blood samples. Post partum hemorrhage. Timepoint: 24 hours after delivery. Method of measurement: Comparison of hemoglobin before and after surgery and using the formula to estimate the amount of bleeding. Karaj University of Medical Sciences Approved 2022-08-13 Research Ethics Committees of Alborz University of Medical Sciences Golshahr street karaj Alborz Iran (Islamic Republic of)