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IRCT2012072910324N2 IRCT 2012-08-09 Womens Reproductive Health Research center, Tabriz University of Medical Sciences The effect of intravenous tranexamic acid on blood loss after vaginal delivery The effect of intravenous tranexamic acid on blood loss after vaginal delivery: A Randomized Controlled Trial 2012-08-15 anticipated 120 Complete https://irct.ir/trial/10785 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention. N/A postpartum haemorrhage. Intervention 1: Intervention group: After delivery of anterior shoulder, 1g tranexamic acid in 200 ml normal saline will be infused intravenously over 10 minutes. Intervention 2: Control group: After delivery of anterior shoulder, 1g placebo of tranexamic acid in 200 ml normal saline will be infused intravenously over 10 minutes.
public Dr.Mojgan Mirghafourvand
Tabriz Nursing & midwifery Faculty , South Shariaty
Tabriz Iran (Islamic Republic of) 51745-347 +98 41 1479 6770 Mirghafourvandm@tbzmed.ac.ir, Mirg1385@yahoo.com Tabriz University of Medical Sciences, Nursing & Midwifery Faculty scientific Dr. Mojgan Mirghafourvand
Tabriz Nursing & midwifery Faculty , South Shariaty
Tabriz Iran (Islamic Republic of) 51745-347 +98 41 1479 6770 Mirghafourvandm@tbzmed.ac.ir Tabriz University of Medical Sciences, Nursing & Midwifery Faculty Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion criteria: -Women with singleton pregnancy between 38 to 42 weeks - Cephalic presentation - No history of cesarean section or uterine surgery - No history of uterine myoma - Normal blood pressure - No history of postpartum haemorrhage - No history of coagulation disorders - No history of heart disease - No history of renal disease - No history of blood disorders and anemia - No history of cerebrovascular disease - Absence of diabetes and preeclampsia in pregnancy current - Absence of polyhydramnious of macrosomia in the current pregnancy - lack of long-term induction of labor in first stage Exclusion criteria: - Instrumental delivery - Extensive vaginal and cervical lacerations - Need for placenta curettag - Continuous pressure in the fundus of the uterus before the fetus and placenta expulsion. 18 years 35 years Female O72.1 Other immediate postpartum haemorrhage Treatment - Drugs Placebo Intervention group: After delivery of anterior shoulder, 1g tranexamic acid in 200 ml normal saline will be infused intravenously over 10 minutes. Control group: After delivery of anterior shoulder, 1g placebo of tranexamic acid in 200 ml normal saline will be infused intravenously over 10 minutes. Comparison of measured blood loss after delivery in the intervention group (receiving tranexamic acid and oxytocin) and control group ( receiving placebo of tranexamic acid and oxytocin). Timepoint: first two hours after delivery. Method of measurement: Differences between the weight of the full and empty container and the dry and bloody plastic cover, drapes and quaze pads will be recorded during the first two hours after delivery and blood loss will be assessed by the method of Gai et al. Comparison of the calculated blood loss after delivery in the intervention group (receiving tranexamic acid and oxytocin) and control group ( receiving placebo tranexamic acid and oxytocin). Timepoint: Before and 12-24 hours after delivery. Method of measurement: Calculated blood loss will be assessed according to pre- and post delivery hematocrit. Comparison of postdelivery hematocrit with effect control of predelivery hematocrit between intervention group(receiving tranexamic acid and oxytocin) and control group (receiving placebo of tranexamic acid and oxytocin). Timepoint: Before and 12-24 hours after delivery. Method of measurement: hematocrit assessment. Comparison of postdelivery Hemoglobin with effect control of predelivery Hemoglobin between intervention group (receiving tranexamic acid and oxytocin) and control group (receiving placebo of tranexamic acid and oxytocin). Timepoint: Before and 12-24 hours after delivery. Method of measurement: Hemoglobin assessment. Comparison of the mean duration of the third stage of labor between intervention group (receiving tranexamic acid and oxytocin) and control group (receiving placebo of tranexamic acid and oxytocin). Timepoint: From newborn delivery to exclusion of the placenta. Method of measurement: Check of the time in second. Comparsion of need for additional uterotonic medication after delivery between intervention group (receiving tranexamic acid and oxytocin) and control group (receiving placebo of tranexamic acid and oxytocin). Timepoint: 30, 45, 60, 90 and 120 minute after delivery. Method of measurement: Checklist. Comparison of vital signs between intervention group (receiving tranexamic acid and oxytocin) and control group (receiving placebo of tranexamic acid and oxytocin). Timepoint: 15-30-45-60-90 and 120minutes after delivery. Method of measurement: cheklist. Womens Reproductive Health Research center, Tabriz University of Medical Sciences Approved 2012-06-13 Tabriz University of Medical Sciences Ethics Committee Tabriz-Golgasht street-Tabriz University of Medical Sciences-Building 2 - Floor 3 Tabriz Iran (Islamic Republic of)