Condition 1: hemorrhage following delivery. Condition 2: hemorrhage following delivery. Condition 3: hemorrhage following delivery. Condition 4: complications after delivery. Condition 5: hemorrhage following delivery. haemorrhage after delivery of fetus or infant Third-stage haemorrhage Complication of labour and delivery, unspecified Other specified complications of labour and delivery Other immediate postpartum haemorrhage
Conditions
Interventions
Intervention 1: Intervention group received 10 mg/kg intravenous TXA in 100 mL normal saline. Intervention 2: Control group received one vial of distilled water (as placebo) in 100 mL normal saline.
Treatment - Drugs
Prevention
Intervention group received 10 mg/kg intravenous TXA in 100 mL normal saline.
Control group received one vial of distilled water (as placebo) in 100 mL normal saline.
Sponsors
Iran University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Pregnant singleton gestational age between 37-42 weeks normal blood pressure (< 140/90 mmHg) informed consent for the study
Exclusion criteria
Exclusion criteria: history of coagulopathy pre-eclampsia placental abruption hypersensitivity to tranexamic acid Body Mass Index(BMI) of more than 30 episiotomy history of cardiac, hepatic, renal and neurologic disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin level. Timepoint: At the time of admission and 6 hours after delivery . Method of measurement: blood test. | — |
Secondary
| Measure | Time frame |
|---|---|
| Urine output. Timepoint: was checked at the beginning of labor and then during 6 hours after delivery ; every 15 minutes after labor for the first hour and then every 30 minutes for the second hour and finally every hour for another 4 hours. Method of measurement: Data sheets, Monitoring of urine output.;Respiratory rate. Timepoint: was checked at the beginning of labor and then during 6 hours after delivery ; every 15 minutes after labor for the first hour and then every 30 minutes for the second hour and finally every hour for another 4 hours. Method of measurement: Data sheets, Monitoring of respiratory rate.;Blood pressure. Timepoint: was checked at the beginning of labor and then during 6 hours after delivery ; every 15 minutes after labor for the first hour and then every 30 minutes for the second hour and finally every hour for another 4 hours. Method of measurement: Data sheets, Monitoring of blood pressure.;Pulse rate. Timepoint: was checked at the beginning of labor and then during 6 hours after delivery ; every 15 minutes after labor for the first hour and then every 30 minutes for the second hour and finally every hour for another 4 hours. Method of measurement: Data sheets,Monitoring of pulse rate.;Need of additional uterotonic agents . Timepoint: Any time after delivery. Method of measurement: Data sheets, using uterotonic agents.;Need of blood transfusion. Timepoint: Any time after delivery up to 24 hours. Method of measurement: blood transfusion.;Need to surgical interventions. Timepoint: Any time after delivery up to 24 hours. Method of measurement: surgical interventions.;Side effects of Tranexamic acid. Timepoint: Any time after delivery up to 42 days. Method of measurement: Data sheets. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMaryam Kashanian
Iran University of Medical Sciences
Outcome results
None listed