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IRCT20180819040830N2 IRCT 2020-04-29 Shahid Beheshti University of Medical Sciences Tranexamic Acid for Decreasing the Blood Loss Efficacy and Safety of Prophylactic Use of Tranexamic Acid for Decreasing the Blood Loss in Elective Cesarean Section: A Placebo-Controlled Randomized Clinical Trial 2020-02-29 anticipated 200 Complete https://irct.ir/trial/45862 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: --, Randomization description: computer-generated blocks of 4, block randomization, Blinding description: Patient and gynecologist who performed the cesarean section and research assistant who measured the bleeding volume were blinded to the intervention. research assistant who prepared the drug and placebo for administration were open to the intervention. 3 peri-operative hemorrhage. Intervention 1: "Intervention group": received a bolus of 1gm TXA (Tranexip®,Tavexamic acid, 500mg/5ml, for slow IV injection, Caspian Tamin Pharmaceutical Co, Tehran, Iran) if their body weight was <90 kg and 1.5 gram if their body weight was >90 kg diluted in 15 ml of 5% dextrose intravenously. Intervention 2: Control group: Receiving routine and 15 ml Dextrose water 5% IV injection as placebo. No - There is not a plan to make this available Justification or reason for not sharing IPD is "There is no further information"
public Zahra Naeiji
Shishegar Khane St., Fadayian Eslam Blv. Shoosh Sq.
Tehran Iran (Islamic Republic of) 1445763693 +98 21 5506 2628 zahranaeiji98@yahoo.com Shahid Beheshti University of Medical Sciences scientific Zahra Naeiji
Shishegar Khane St., Fadayian Eslam Blv. Shoosh Sq.
Tehran Iran (Islamic Republic of) 1445763693 +98 21 5506 2628 zahranaeiji98@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) singleton pregnant women elective cesarean section gestational age between 37 and 42 weeks 18 years no limit Female patients with Known allergy to TXA history of thromboembolic or coagulation disorders known history of renal, cardiac or hepatic impairment gestational or chronic hypertension/pre-eclampsia placental disorders polyhydramnios patients who had received aspirin 1 week before surgery O72.1 Other immediate postpartum hemorrhage Treatment - Drugs Treatment - Drugs "Intervention group": received a bolus of 1gm TXA (Tranexip®,Tavexamic acid, 500mg/5ml, for slow IV injection, Caspian Tamin Pharmaceutical Co, Tehran, Iran) if their body weight was <90 kg and 1.5 gram if their body weight was >90 kg diluted in 15 ml of 5% dextrose intravenously. Control group: Receiving routine and 15 ml Dextrose water 5% IV injection as placebo Intra-operative and post-operative blood loss in elective cesarean section. Timepoint: From skin incision to hours after surgery. Method of measurement: Intra-operative blood loss (from skin incision to skin closure) was measured by gravimetric method. Soaked drapes, mops, sponges, pads, and operation table perineal sheet were weighed with an electronic weighing scale before and after the surgery. The difference between their wet and dry weights was considered as the collected blood. Each mg of measured weight was considered as equivalent to 1 ml of blood. The total amount of blood loss (ml) was determined as the sum of blood absorbed by soaked mops, sponges, pads, drapes and perineal sheet plus blood collected in suction bottle after placental delivery (to exclude the measurement of amniotic fluid). Post-operative blood loss (first 6 hours after skin closure) was measured by weighing and numbering the vaginal pads used by the patient. Occurrence of minor or major adverse reactions of tranexamic acid (headaches, fatigue, abdominal pain, nausea, vomiting, diarrhea, seizures, anaphylaxis, visual disturbances, pulmonary embolism, deep vein thrombosis, myocardial infarction, cerebrovascular accidents). adverse neonatal outcome and labor complications like increased uterine contractions and placental separation were also considered as secondary outcomes. Timepoint: From drug administration to 6 hours after surgery. Method of measurement: History taking, physical exam, para-clinical assessments as indicated. Preventative Gynecology Research Center Approved 2018-11-03 Ethics committee of Shahid Beheshti University of Medical Sciences Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran Tehran Iran (Islamic Republic of)