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IRCT20091010002558N7 IRCT 2020-12-08 Ghoum University of Medical Sciences Effect of prophylactic intravenous tranexamic acid on blood loss after cesarean delivery Effect of prophylactic intravenous tranexamic acid on blood loss after cesarean delivery 2016-03-21 anticipated 44 Complete https://irct.ir/trial/51451 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: The research population is randomly divided into two groups of intervention and control. Random assignment of patients to two groups is based on the block method. Block size 4 is considered. So we have six quadruple blocks consisting of AABB, ABAB, BBAA, BABA, ABBA, BAAB. The selection of each block will also be random and will be done using dice. For example, if the number 3 is rolled in a dice, the BBAA block is considered, so the first two patients are assigned to treatment B and the next two patients to treatment A. The dice will be thrown ten times to complete the assignment of patients to treatment groups. Assignment of treatment to groups A and B will also be based on accident (coin toss), Blinding description: In order to hide the medication allocation, two vials of the tranexamic acid and distilled water were placed in similar opaque sequentially numbered sealed packages by an Operator room technician that not involved in sampling and analysis, who maintained the medication administration code. In this way, the data evaluators and participants had no knowledge of the study medication. 1 postpartum blood loss. Intervention 1: Intervention group: Women in the study group, received one gram intravenous TA, 10 min before skin incision in 200 mL normal saline over 10 min. In this study, TA was supplied in 2 × 500 mg/ mL ampoules obtained from kharazmi Pharmaceutical Company in Iran. Intervention 2: Control group: Women in the control group, received 10mL placebo (distilled water) 10 min before skin incision in 200 mL normal saline over 10 min. The placebo comprised 2×5 ml distilled water ampoules from Shahid Ghazi Pharmaceutical Company in Tabriz - Iran. Yes - There is a plan to make this available What will be shared: All of the above are documented and can be sent via email. When: 6 months after printing the results To whom: Researchers working in scientific institutes Conditions: Scientific uses to continue the work process or aggregate data Where to obtain: To the researcher email How to obtain: Refer a reputable scientific institution to the applicant via email Comments:
public Esmat Jafarbegloo
No 2. East moallem, moallem Blvd, Qom
Qom Iran (Islamic Republic of) 3715835155 +98 25 3783 1371 jafarbegloo_2004@yahoo.com Ghoum University of Medical Sciences scientific Esmat Jafarbegloo
No2. East moallem. moallem Blvd. Qom.
Qom Iran (Islamic Republic of) 3715835155 +98 25 3783 1371 jafarbegloo_2004@yahoo.com Ghoum University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria included age 18-35 years, single pregnancy, cesarean delivery, blood pressure less than 140 over 90, no history of thromboembolism and coagulation disease, no uterine myoma, no IUFD fetus, no decolonization and no history or Active heart, liver and kidney diseases 18 years 35 years Female During cesarean section, if placental adhesions such as placenta, increta and percorta are observed, individuals will be excluded. Treatment - Drugs Placebo Intervention group: Women in the study group, received one gram intravenous TA, 10 min before skin incision in 200 mL normal saline over 10 min. In this study, TA was supplied in 2 × 500 mg/ mL ampoules obtained from kharazmi Pharmaceutical Company in Iran. Control group: Women in the control group, received 10mL placebo (distilled water) 10 min before skin incision in 200 mL normal saline over 10 min. The placebo comprised 2×5 ml distilled water ampoules from Shahid Ghazi Pharmaceutical Company in Tabriz - Iran. Blood loss after cesarean. Timepoint: The lost blood will be controlled in two times: A: The time of placenta departure until the end of cesarean section B: From the end of cesarean section to 2 hours after delivery. Method of measurement: In practice, the volume of blood in the suction and the weight of the gases and blood-stained tampons will be used to check for postpartum hemorrhage. A digital scale (with an error rate of 10 grams) will be used to weigh gases and guns. To collect the blood lost after the cesarean section, immediately after the end of the cesarean section, a disposable plastic cover with a certain weight is spread under the cesarean section woman and she will be weighed 2 hours after the cesarean section. Hemoglobin and hematocrit levels. Timepoint: Hemoglobin and hematocrit levels will be monitored before and 12-24 hours after delivery. Method of measurement: hemoglobin and hematocrit are measured by blood test. Ghoum University of Medical Sciences Approved 2016-02-10 Ethics Committee of Qom University of Medical Sciences saheli street Qom Ghoum Iran (Islamic Republic of)