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Prophylactic Tranexamic Acid Doses in Caesarean Section

NCT02739815Phase 4

Key facts

Status: Completed
Start: Apr 2016
Primary completion: Jun 2016
Countries: 1
Sponsor: Talkha Central Hospital
Modality: Small Molecules

Drugs: tranexamic acid
Conditions: postpartum hemorrhage (PPH)

Overview

Phase 4, randomised, double-blind trial of tranexamic acid in postpartum hemorrhage (PPH) (4 arms), sponsored by Talkha Central Hospital. Primary endpoint: Total Blood Loss Volume up to 7 hours. Started Apr 2016; status: completed.

Design

4 arms

Study design: RandomizedDouble-blind

Placebo
Placebo (distilled water) in Z solution (saline + antibiotic)
T1 (15 mg/kg)
Tranexamic Acid 15 mg/kg in Z solution
T2 (20 mg/kg)
Tranexamic Acid 20 mg/kg in Z solution
T3 (25 mg/kg)
Tranexamic Acid 25 mg/kg in Z solution

Who it enrols

Inclusion: Singleton pregnancy at term (38±5 days to 40 weeks), elective or emergency secondary LSCS. Exclusion: Severe medical/surgical complications (heart, liver, kidney, brain, blood disorders), abruptio placenta, placental abnormalities, polyhydramnios, macrosomia, preeclampsia, allergy to TXA, history of thromboembolic disorders, severe anemia.

Endpoints

Primary

Total Blood Loss VolumeUp to 7 hours

Secondary

Duration of surgeryUp to 1 hour
Hemoglobin level6 hours
Maternal weight2 hours
Hematocrit value6 hours
Need for blood or blood products transfusionUp to 6 hours
Need for additional ecbolicsUp to 6 hours
Need for hysterectomyUp to 6 hours
Need for uterine artery ligationUp to 6 hours

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