peri-operative hemorrhage. Other immediate postpartum hemorrhage
Conditions
Interventions
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
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: singleton pregnant women elective cesarean section gestational age between 37 and 42 weeks
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactZahra Naeiji
Shahid Beheshti University of Medical Sciences
Outcome results
None listed